0A4F4F9BD490A749D5437F821CF06DF1
Guideline for Good Clinical Practice (GCP)
https://clinregs.niaid.nih.gov/sites/default/files/documents/sierra_leone/PBSL-GCP-Guideline-V2.pdf
http://leaux.net/URLS/ConvertAPI Text Files/8C6D82FBA46324AC498664C8EFFCA4C3.en.txt
Examining the file media/Synopses/8C6D82FBA46324AC498664C8EFFCA4C3.html:
This file was generated: 2020-07-15 06:28:25
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
...
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
p.000027: • A majority of the research ethics committee, other than prison members, shall have no association with the
p.000027: prison(s) involved, apart from their membership of the research ethics committee;
p.000027: • At least one member of the research ethics committee shall be a prisoner, or a prisoners'
p.000027: representative with appropriate background and experience to serve in that capacity. Where a research project is
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
...
Political / Indigenous
Searching for indicator indigenous:
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p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
...
Political / criminal
Searching for indicator criminal:
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p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
...
p.000081: medical care which might have the effect of weakening the physical and mental condition of the patient.”
p.000081: The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and
p.000081: prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.
p.000081: In current medical practice, most diagnostic, therapeutic or prophylactic procedures involve hazards. This
p.000081: applies especially to biomedical research.
p.000081: Medical progress is based on research which ultimately must rest in part on experimentation
p.000081: involving human subjects.
p.000081: In the field of biomedical research a fundamental distinction must be recognized between medical research in which the
p.000081: aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is
p.000081: purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.
p.000081: Special caution must be exercised in the conduct of research which may affect the environment, and the
p.000081: welfare of animals used for research must be respected.
p.000081: Because it is essential that the results of laboratory experiments be applied to human beings to further scientific
p.000081: knowledge and to help suffering humanity, the World Medical Association has prepared the following
p.000081: recommendations as a guide to every physician in biomedical research involving human subjects. They should be kept
p.000081: under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over
p.000081: the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own
p.000081: countries.
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000081:
p.000082: 82
p.000082:
p.000082: I. Basic principles
p.000082:
p.000082: 1. Biomedical research involving human subjects must conform to generally accepted scientific principles and
p.000082: should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the
p.000082: scientific literature.
p.000082: 2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in
p.000082: an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed
p.000082: committee independent of the investigator and the sponsor provided that this independent committee is in conformity
p.000082: with the laws and regulations of the country i which the research experiment is performed.
p.000082: 3. Biomedical research involving human subjects should be conducted only by scientifically
p.000082: qualified persons and under the supervision of a clinically competent medical person. The responsibility for the
p.000082: human subject must always rest with a medically qualified person and never rest on the subject of the
p.000082: research, even though the subject has given his or her consent.
p.000082: 4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the
p.000082: objective is in proportion to the inherent risk to the subject.
p.000082: 5. Every biomedical research project involving human subjects should be preceded by careful assessment of
...
Political / nomad
Searching for indicator nomads:
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p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
p.000011: The guideline was partly derived from the International Conference on Harmonization Good Clinical Practice
...
Political / political affiliation
Searching for indicator party:
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p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
p.000005: of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors)
p.000005: with direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000005: requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
p.000005: “Drug/Medicine” Includes
p.000005:
p.000005: 1. A substance or mixture of substances prepared, sold or represented for use in
p.000005:
p.000005: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000005:
p.000005: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical state or the symptoms
p.000005: of it, in man or animal, or
p.000005: 2. Nutritional supplements
p.000005:
p.000005: Documentation
p.000005: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and
p.000005: scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a
p.000005: trial, the factors affecting a trial, and the actions taken.
p.000005: Essential Documents
p.000005: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data
p.000005: produced (see Essential Documents for the Conduct of a Clinical Trial).
p.000005: Good Clinical Practice (GCP)
p.000005: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000005: trials that provides assurance that the data and reported results are
p.000005:
p.000005:
p.000006: 6
p.000006:
...
p.000030: of the clinical trial at a clinical site. A Principal Investigator must have had previous experience as a
p.000030: co-investigator in at least two trials in the relevant professional area.
p.000030: 4.1.8. All investigators in a clinical trial as well as the trial monitor must have had formal training in Good
p.000030: Clinical Practice (GCP) within the last two years.
p.000030: 4.1.9 Upon signing the application, all parties accept the responsibility that all applicable regulations and
p.000030: requirements will be adhered to. Furthermore, all parties are responsible for ensuring that the trial is based on and
p.000030: implemented according to well – founded ethical and scientific principles, which are expressed in the Helsinki
p.000030: Declaration (see Appendix 3) and its current revisions as well as in the local and international guidelines for GCP.
p.000030: 4.2 Adequate Resources
p.000030: 4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting
p.000030: the required number of suitable subjects within the agreed recruitment period.
p.000030: 4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial
p.000030: period.
p.000030: 4.2.3 The investigator should have available an adequate number of qualified staff and
p.000030:
p.000030:
p.000031: 31
p.000031:
p.000031: adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
p.000031: 4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the
p.000031: protocol, the investigational product(s), and their trial-related duties and functions.
p.000031: 4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates
p.000031: trial-related duties and functions conducted at the trial site.
p.000031: 4.2.6 If the investigator/institution retains the services of any individual or party to perform trial-related duties
p.000031: and functions, the investigator/institution should ensure this individual or party is qualified to perform those
p.000031: trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties
p.000031: and functions performed and any data generated.
p.000031: 4.3 Medical Care of Trial Subjects
p.000031: 4.3.1 A medical practitioner (or dentist, when appropriate), who is an investigator or a sub-investigator for the
p.000031: trial, should be responsible for all trial-related medical (or dental) decisions. The qualified medical practitioner
p.000031: should also be licensed with the Sierra Leone Medical and Dental Council or the Pharmacy Board of Sierra Leone. The
p.000031: medical care given to, and medical decisions made on behalf of the subjects must always be the
p.000031: responsibility of a qualified medical practitioner or when appropriate a qualified dentist registered with the Medical
p.000031: and Dental Council.
p.000031: 4.3.2 During and following a subject's participation in a trial, the investigator should ensure that adequate medical
p.000031: care is provided to a subject for any adverse events, including clinically significant laboratory values, related to
p.000031: the trial. The investigator should inform a subject when medical care is needed for intercurrent illness(es) of which
p.000031: the investigator becomes aware.
p.000031: 4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation
p.000031: in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
p.000031: 4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a
p.000031: trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the
p.000031: subject's rights.
...
p.000040: 5.1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with
p.000040: written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in
p.000040: compliance with the protocol, GCP, and the PBSL regulatory requirement(s).
p.000040: 5.1.2 The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial
p.000040: related sites, source data/documents, and reports for the
p.000040:
p.000041: 41
p.000041:
p.000041: purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.
p.000041: 5.1.3 Quality control should be applied to each stage of data handling to ensure that all data are reliable and have
p.000041: been processed correctly.
p.000041: 5.1.4 Agreements, made by the sponsor with the investigator/institution and any other parties involved with
p.000041: the clinical trial, should be in writing, as part of the protocol submitted to PBSL or in a separate agreement
p.000041: 5.2 Contract Research Organization (CRO)
p.000041: 5.2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate
p.000041: responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should
p.000041: implement quality assurance and quality control.
p.000041: 5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified
p.000041: in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its
p.000041: behalf, including trial-related duties and functions that are subcontracted to another party by the
p.000041: sponsor’s contracted CRO(s).
p.000041: 5.2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the
p.000041: sponsor.
p.000041: 5.2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial
p.000041: related duties and functions of a sponsor.
p.000041: 5.3 Medical Expertise
p.000041: The sponsor should designate appropriately qualified medical personnel who will be readily available to
p.000041: advise on trial related medical questions or problems. If necessary, outside consultant(s) may be appointed for this
p.000041: purpose.
p.000041: 5.4 Trial Design
p.000041: 5.4.1 The sponsor should utilize qualified individuals (e.g. biostatisticians, clinical pharmacologists,
p.000041: Pharmacists and physicians) as appropriate, throughout all stages of the trial process, from designing the
p.000041: protocol and CRFs and planning the analyses to analyzing and preparing interim and final clinical trial reports.
p.000041:
p.000041:
p.000041: 5.4.2 For further guidance: Clinical Trial Protocol and Protocol Amendment(s) (see Section 6 of this
p.000041: guideline).
p.000041:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042: 5.5 Trial Management, Data Handling, and Record Keeping
p.000042: 5.5.1 The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to
p.000042: handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.
p.000042: 5.5.2 The sponsor may consider establishing an independent data-monitoring committee (IDMC) to assess the progress of a
p.000042: clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the
...
p.000072:
p.000072:
p.000072: To document compliance with applicable labelling regulations and appropriateness of instructions provided to the
p.000072: subjects
p.000072: Investigator/I nstitution
p.000072: Sponsor
p.000072:
p.000072: X
p.000072:
p.000072:
p.000072: 14. INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
p.000072: (if not included in protocol or Investigator’s Brochure)
p.000072: 15. SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND
p.000072: TRIAL-RELATED MATERIALS
p.000072:
p.000072:
p.000072: 16. CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000072:
p.000072: 17. DECODING PROCEDURES FOR BLINDED TRIALS
p.000072: To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational
p.000072: products and trial-related materials
p.000072:
p.000072:
p.000072: To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related
p.000072: materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000072:
p.000072: To document identity, purity, and strength of investigational product(s) to be used in the trial
p.000072:
p.000072: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000072: the blind for the remaining subjects' treatment
p.000072: X X
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: X X
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: X
p.000072:
p.000072:
p.000072:
p.000072: X X(third party if applicable)
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: NO. Title of Document Purpose
p.000073: Located in File
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 18. MASTER RANDOMISATION LIST
p.000073:
p.000073: 19. PRE-TRIAL MONITORING REPORT
p.000073:
p.000073:
p.000073: To document method for randomisation of trial population
p.000073:
p.000073: To document that the site is suitable for the trial (may be combined with 20)
p.000073: Investigator/I nstitution
p.000073: Sponsor
p.000073:
p.000073: X
p.000073: (third party if applicable
p.000073: X
p.000073:
p.000073:
p.000073: 20. TRIAL INITIATION MONITORING REPORT
p.000073:
p.000073:
p.000073: During the Clinical Conduct of the Trial
p.000073: To document that trial procedures X X were reviewed with the investigator
p.000073: and the investigator’s trial staff ( may be combined with 19)
p.000073: In addition to having on file the above documents the following should be added to the files during the trial as
p.000073: evidence that all new relevant information is documented as it becomes available.
p.000073:
p.000073: 21. INVESTIGATOR’S BROCHURE UPDATE
p.000073: To document that investigator is X X informed in a timely manner of
p.000073: relevant information as it becomes available
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: NO. Title of Document Purpose
p.000074: Located in Files of
p.000074:
p.000074:
p.000074: Investigator/ Institution
p.000074: Sponsor
p.000074:
p.000074: 22. ANY REVISION TO:
p.000074: -Protocol/amendment(s) and CRF
p.000074: -Informed consent form any other written
p.000074: -Information provided to subjects
p.000074: -Advertisement for subject recruitment
p.000074: used)
p.000074: 23. DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
...
Searching for indicator political:
(return to top)
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
p.000011: The guideline was partly derived from the International Conference on Harmonization Good Clinical Practice
p.000011: (ICH E6(R2) GCP), World Health Organization (WHO) Guidelines for Good Clinical Practices for Trials on
p.000011: Pharmaceutical Products and from the International Ethical Guidelines for Biomedical Research involving
p.000011: human subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS) in
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: collaboration with World Health Organization (WHO 2002).
p.000012:
p.000012: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical investigators,
p.000012: industry/sponsors/monitors, institutions/ethics committees, and government regulators. The Guidelines are therefore
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.000010: Subject/Trial Subject
p.000010: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a
p.000010: control.
p.000010: Subject Identification Code
p.000010: A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in
p.000010: lieu of the subject's name when the investigator reports adverse events and/or other trial related data.
p.000010: Trial Site
p.000010: The location(s) where trial-related activities are actually conducted.
p.000010: Unexpected Adverse Drug Reaction
p.000010: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
p.000010: Investigator's Brochure for an unapproved investigational product or package insert/summary of product
p.000010: characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and
p.000010: Standards for Expedited Reporting).
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
...
p.000012: addressed to investigators, pharmaceutical, manufacturers and other sponsors of research, the general public and
p.000012: all, those who have an interest in clinical trials research in Sierra Leone.
p.000012: The guidelines are also applicable to academic and contract clinical research and are intended to be
p.000012: applied during all stages of drug development including pre and post product registration and marketing, and they are
p.000012: also applicable, in whole or in part to biomedical research in general. They also provide a resource for editors to
p.000012: determine the acceptability of reported research for publication and specifically, on any study that could influence
p.000012: the use or the terms of registration of a pharmaceutical product.
p.000012: 1.1 RATIONAL FOR THIS GUIDELINE?
p.000012:
p.000012: The purpose of this guideline is to provide Sierra Leone with clearly articulated standards of good clinical practice
p.000012: in research that are also relevant to local realities and contexts and to ensure that clinical trials conducted on
p.000012: human participants are designed and conducted according to sound scientific and ethical standards within the framework
p.000012: of good clinical practice. Compliance with these standards provides the public with assurance that the
p.000012: rights, safety and wellbeing of trial participants are protected and that clinical trial data are credible.
p.000012: 1.2 PRINCIPLES
p.000012:
p.000012: Although well-designed clinical trials will undoubtedly fit in within these modern ethical sentiments, the potential to
p.000012: violate the rights of trial participants particularly in vulnerable communities necessitates the need to articulate
p.000012: ethical guidelines for clinical trials.
p.000012: The principles of GCP include:
p.000012:
p.000012: 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
p.000012: Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
p.000012: 2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000012: benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated
p.000012: benefits justify the risks.
p.000012: 3) The rights, safety, and well-being of the trial subjects are the most important considerations and
p.000012: should prevail over interests of science and society.
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: 4) The available nonclinical and clinical information on an investigational product should be adequate to
p.000013: support the proposed clinical trial.
p.000013: 5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
p.000013: 6) A trial should be conducted in compliance with the protocol that has received prior institutional review
p.000013: board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
p.000013: 7) The medical care given to, and medical decisions made on behalf of, subjects should always be the
p.000013: responsibility of a qualified physician or, when appropriate, of a qualified dentist.
...
p.000014: different social and economic circumstances. Research projects being undertaken in South Africa should be carefully
p.000014: evaluated and examined as to its current and future relevancy.
p.000014: The findings of the proposed study should be translatable into mechanisms for improving the health status of
p.000014: Sierra Leoneans. Solutions should have the potential for implementation.
p.000014: 1.2.2 Study Designs: Appropriate study designs are critical in contributing to answering scientific
p.000014: questions. The study design must therefore demonstrate a high probability for providing answers to specific research
p.000014: questions. Adequate supporting information and explanation on the study sample size and study population must be
p.000014: provided.
p.000014: The social context of a proposed research population that creates conditions for possible exploitation or
p.000014: increased vulnerability among potential research participants should be assessed, where this is relevant. Steps
p.000014: must be taken to overcome these conditions, and to promote and protect the dignity, safety and welfare of
p.000014: participants. The vulnerability factors and steps that will be taken to offset these should be addressed
p.000014: in the study design and clearly outlined in the research protocol. It is imperative that sound study
p.000014: designs, and use of universally accepted ethical standards are applied in both vulnerable and non-vulnerable
p.000014: communities.
p.000014: The design of the study should in no way prejudice the ongoing treatment and care of patients, nor should it in anyway
p.000014: undermine or confuse patients with respect to the best available local standard treatment practices and national policy
p.000014: approaches. If these are not ensured, then the design is unethical.
p.000014: 1.2.3 Investigator Competence: The Principal Investigator's (and other investigators') competence
p.000014: is assessed by two major parameters: technical and humanistic. Technical competence which includes research
p.000014: competence is assessed by education, knowledge, certification and experience such that the investigator is able to
p.000014: assume responsibility for the proper conduct of a trial, should meet all the qualifications
p.000014: specified by applicable regulatory requirement(s), and should provide evidence of such qualifications through an
p.000014: up-to-date curriculum vitae and/or other relevant documentation requested PBSL. Humanistic parameters require
p.000014: compassion and empathy. This is provided by a proper clinical and research environment, encompassing good
p.000014: research mentoring. In all cases the Principal Investigator for each
p.000014:
p.000015: 15
p.000015:
p.000015: site must be a Sierra Leonean-based scientist (domicile in Sierra Leone).
p.000015:
p.000015: 1.2.4 Balance of Harm and Benefit: A risk benefit analysis of the study should precede the conduct of the
p.000015: research itself. The risk-benefit analysis should take full cognisance of benefits and harms beyond the life of the
...
p.000015: medical and non-medical professionals. SLERSC is the national ethics committee which advises the Ministry of Health and
p.000015: Sanitation on health research ethics in Sierra Leone. All clinical trials conducted in Sierra Leone must undergo
p.000015: ethical review SLERSC.
p.000015:
p.000016: 16
p.000016:
p.000016: • Data and Safety Monitoring Committees: These committees oversee ongoing clinical trials with respect to treatment,
p.000016: efficacy and safety. In the advent of clear evidence of efficacy or harm, prior to the end of the trial, premature
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
...
p.000018: 1.5.9 The Inspector: The inspector is a qualified employee of local and international regulatory authority(ies)
p.000018: whose responsibility is to conduct announced or unannounced inspection visits at clinical trial
p.000018: sites/sponsors/CROs/bioequivalence facilities and research ethics committees as required/instructed by the
p.000018: regulatory authority(ies). Most inspectorate visits will be prearranged but some will not especially where
p.000018: there is suspected serious breaches of the GCP or malpractices.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 1.6 CLINICAL TRIAL APPROVAL IN SIERRA LEONE
p.000019:
p.000019: The following steps must be undertaken before a clinical trial can be conducted in Sierra Leone:
p.000019: • PBSL Approval: A sponsor/principal investigator (PI) must apply to the PBSL for approval to conduct a trial for a
p.000019: non-registered drug or a registered drug for new indications etc;
p.000019: • SLERSC Approval: All clinical trials to be conducted in Sierra Leone must apply for and receive ethical approval
p.000019: from the ethics committee
p.000019: 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000019: 3.1 RESPONSIBILITIES
p.000019: 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be
p.000019: paid to trials that may include vulnerable subjects.
p.000019: 3.1.2 The IRB/IEC should obtain the following documents:
p.000019:
p.000019: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator
p.000019: proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be
p.000019: provided to subjects, Investigator's Brochure (IB), available safety information, information about payments
p.000019: and compensation available to subjects, the investigator’s current curriculum vitae and/or other
p.000019: documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its
p.000019: responsibilities.
p.000019: The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly
p.000019: identifying the trial, the documents reviewed and the dates for the following:
p.000019: - approval/favourable opinion;
p.000019: - modifications required prior to its approval/favourable opinion;
p.000019: - disapproval / negative opinion; and
p.000019: - termination/suspension of any prior approval/favourable opinion.
p.000019:
p.000019:
p.000019: 3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a
p.000019: current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
p.000019:
p.000019:
p.000020: 20
p.000020:
...
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
...
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
p.000027: • A majority of the research ethics committee, other than prison members, shall have no association with the
p.000027: prison(s) involved, apart from their membership of the research ethics committee;
p.000027: • At least one member of the research ethics committee shall be a prisoner, or a prisoners'
p.000027: representative with appropriate background and experience to serve in that capacity. Where a research project is
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
...
Searching for indicator vulnerability:
(return to top)
p.000013: and impartial oversight of consent procedures. To follow is a brief discussion on some of these issues as they
p.000013: relate to Sierra Leone.
p.000013: 1.2.1. Study Rationale and Motivation: A study rationale and motivation which does not ask relevant and important
p.000013: questions is unethical. The study rationale should demonstrate that the study question under consideration
p.000013: has not been substantially
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: answered and that adequate systematic review of the subject under discussion was done. Relevant and
p.000014: important questions should also be problems that significantly affect local and regional populations.
p.000014: Research and clinical trials however should be conducted within various settings and applied to communities with
p.000014: different social and economic circumstances. Research projects being undertaken in South Africa should be carefully
p.000014: evaluated and examined as to its current and future relevancy.
p.000014: The findings of the proposed study should be translatable into mechanisms for improving the health status of
p.000014: Sierra Leoneans. Solutions should have the potential for implementation.
p.000014: 1.2.2 Study Designs: Appropriate study designs are critical in contributing to answering scientific
p.000014: questions. The study design must therefore demonstrate a high probability for providing answers to specific research
p.000014: questions. Adequate supporting information and explanation on the study sample size and study population must be
p.000014: provided.
p.000014: The social context of a proposed research population that creates conditions for possible exploitation or
p.000014: increased vulnerability among potential research participants should be assessed, where this is relevant. Steps
p.000014: must be taken to overcome these conditions, and to promote and protect the dignity, safety and welfare of
p.000014: participants. The vulnerability factors and steps that will be taken to offset these should be addressed
p.000014: in the study design and clearly outlined in the research protocol. It is imperative that sound study
p.000014: designs, and use of universally accepted ethical standards are applied in both vulnerable and non-vulnerable
p.000014: communities.
p.000014: The design of the study should in no way prejudice the ongoing treatment and care of patients, nor should it in anyway
p.000014: undermine or confuse patients with respect to the best available local standard treatment practices and national policy
p.000014: approaches. If these are not ensured, then the design is unethical.
p.000014: 1.2.3 Investigator Competence: The Principal Investigator's (and other investigators') competence
p.000014: is assessed by two major parameters: technical and humanistic. Technical competence which includes research
p.000014: competence is assessed by education, knowledge, certification and experience such that the investigator is able to
p.000014: assume responsibility for the proper conduct of a trial, should meet all the qualifications
p.000014: specified by applicable regulatory requirement(s), and should provide evidence of such qualifications through an
p.000014: up-to-date curriculum vitae and/or other relevant documentation requested PBSL. Humanistic parameters require
p.000014: compassion and empathy. This is provided by a proper clinical and research environment, encompassing good
p.000014: research mentoring. In all cases the Principal Investigator for each
p.000014:
p.000015: 15
p.000015:
...
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
p.000028: the participant's representative is able to give consent in advance, a research ethics committee may approve a research
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: • adequate provision will be made for informing patients and their relatives about the research, to ensure that
p.000029: stress and other emotional factors do not impair their understanding of it; and
p.000029: • the dependency of patients and their relatives on the medical personnel providing treatment does not affect any
p.000029: decision to participate.
p.000029: 3.4.7 Emergency Care Research: The benefits of emergency care research include improved effective treatment
p.000029: for life-threatening conditions and improving therapies for survival and quality of life. Research into emergency
p.000029: medical treatment needs to involve participants who are experiencing medical emergencies.
p.000029: The distinguishing feature of emergency care research however is that consent to commence a project usually
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
p.000029: Research ethics committee must therefore take great care when assessing emergency care research.
p.000029: Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to
p.000029: obtain consent for inclusion without delaying the initiation of treatment, and so risking a reduction of
p.000029: potential benefits. As such there may be circumstances in which it is not possible to obtain consent for
p.000029: inclusion in emergency care research. After a protocol has been presented by a researcher giving clear reasons to
p.000029: justify the initiation of the emergency care research without consent, a research ethics committee may approve the
p.000029: research without consent provided it is satisfied that:
p.000029: • reasonable steps are being taken to ascertain the religious and cultural sensitivities of patients experiencing
p.000029: medical emergencies;
p.000029: • the condition of the patient precludes the giving of consent;
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.000024: have given their informed consent, except that the father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Individuals engaged in the activity will have no part in (1) any decision as to the timing, method
p.000025: and procedures used to terminate the pregnancy, and/or (2) determining the viability of the foetus at
p.000025: the termination of the pregnancy.
p.000025: No procedural changes, which may cause greater than minimal risk to the foetus or the pregnant woman, will be
p.000025: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
...
Searching for indicator impaired:
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p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
...
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
...
p.000062: described under the following headings where appropriate:
p.000062: − Single dose
p.000062:
p.000062: − Repeated dose
p.000062:
p.000062: − Carcinogenicity
p.000062:
p.000062: − Special studies (e.g. irritancy and sensitisation)
p.000062:
p.000062: − Reproductive toxicity
p.000062:
p.000062: − Genotoxicity (mutagenicity)
p.000062:
p.000062:
p.000062: 7.3.6 Effects in Humans Introduction:
p.000062: A thorough discussion of the known effects of the investigational product(s) in
p.000062: humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics,
p.000062: dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each
p.000062: completed clinical trial should be provided. Information should also be provided regarding results of any use of the
p.000062: investigational product(s) other than from in clinical trials, such as from experience during marketing.
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
p.000063: − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
p.000063:
p.000063:
p.000063: (b) Safety and Efficacy
p.000063: A summary of information should be provided about the investigational product's/products' (including
p.000063: metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were
p.000063: obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of
p.000063: this information should be discussed. In cases where a number of clinical trials have been completed, the use
p.000063: of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear
p.000063: presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those
p.000063: for all the studied indications) would be useful. Important differences in adverse drug reaction
p.000063: patterns/incidences across indications or subgroups should be discussed.
p.000063: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on
p.000063: the basis of prior experiences with the product under investigation and with related products. A description
p.000063: should also be provided of the precautions or special monitoring to be done as part of the
p.000063: investigational use of the product(s).
...
Searching for indicator impairment:
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p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
...
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
p.000028: the participant's representative is able to give consent in advance, a research ethics committee may approve a research
p.000028: project without prior consent if it is satisfied that:
...
Health / Drug Dependence
Searching for indicator dependency:
(return to top)
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: • adequate provision will be made for informing patients and their relatives about the research, to ensure that
p.000029: stress and other emotional factors do not impair their understanding of it; and
p.000029: • the dependency of patients and their relatives on the medical personnel providing treatment does not affect any
p.000029: decision to participate.
p.000029: 3.4.7 Emergency Care Research: The benefits of emergency care research include improved effective treatment
p.000029: for life-threatening conditions and improving therapies for survival and quality of life. Research into emergency
p.000029: medical treatment needs to involve participants who are experiencing medical emergencies.
p.000029: The distinguishing feature of emergency care research however is that consent to commence a project usually
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
p.000029: Research ethics committee must therefore take great care when assessing emergency care research.
p.000029: Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to
p.000029: obtain consent for inclusion without delaying the initiation of treatment, and so risking a reduction of
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: GUIDELINE FOR GOOD CLINICAL PRACTICE (GCP) IN SIERRA LEONE
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Guideline No. : PBSL/PVGCT/GDL/GCP/02-2018 Effective Date. :31st January, 2018
p.000001: Version No. 02
p.000001: 1
p.000001:
p.000001:
p.000001: TABLE OF CONTENTS
p.000001: TITLE PAGE
p.000001: 1
p.000001: TABLE OF CONTENTS.
p.000002: 2
p.000002: 1. GLOSSARY
p.000003: 3
p.000003: 2.INTRODUCTION
p.000012: 12
p.000012: 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 20
p.000012: 4. INVESTIGATOR.
p.000031: 31
p.000031: 5.SPONSOR.
p.000040: 40
p.000040: 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S). 55
p.000040: 7. INVESTIGATOR’S BROCHURE.
p.000059: 59
p.000059: 7.4 APPENDIX 1
p.000066: 66
p.000066: 7.5 APPENDIX 2
p.000067: 67
p.000067: 8. GOOD CLINICAL PRACTICE (GCP) INSPECTIONS. 68
p.000067: 10. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 69
p.000067: 11. APPENDIX 3. DECLARATION OF HELSINKI
p.000082: 82
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000002: 2
p.000002:
p.000002: 1. GLOSSARY
p.000002: Adverse Drug Reaction (ADR)
p.000002: In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic
p.000002: dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should
p.000002: be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship
p.000002: between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be
p.000002: ruled out.
p.000002: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which
p.000002: occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
p.000002: physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
p.000002: Expedited Reporting).
p.000002: Adverse Event (AE)
p.000002: Any untoward medical occurrence in a patient or clinical investigation subject administered a
p.000002: pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An
p.000002: adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory
p.000002: finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether
p.000002: or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data
p.000002: Management: Definitions and Standards for Expedited Reporting).
p.000002: Adult
p.000002: A person who is eighteen (18) years of age or over that age.
p.000002: Amendment (to the protocol)
p.000002: See Protocol Amendment.
p.000002: Applicable Regulatory Requirement(s)
p.000002: Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
p.000002: Approval(s)
p.000002: The affirmative decision of PBSL or the national ethics committee that the clinical trial has been reviewed and may be
p.000002: conducted at the institution site within the constraints set forth by the PBSL or the national ethics committee,
...
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
p.000003: Phase I refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000004: Phase IV trials are conducted after the national drug registration authority has approved a drug for distribution or
p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
p.000005: of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors)
p.000005: with direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000005: requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
p.000005: “Drug/Medicine” Includes
p.000005:
p.000005: 1. A substance or mixture of substances prepared, sold or represented for use in
p.000005:
p.000005: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000005:
p.000005: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical state or the symptoms
p.000005: of it, in man or animal, or
p.000005: 2. Nutritional supplements
p.000005:
p.000005: Documentation
p.000005: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and
p.000005: scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a
p.000005: trial, the factors affecting a trial, and the actions taken.
p.000005: Essential Documents
p.000005: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data
p.000005: produced (see Essential Documents for the Conduct of a Clinical Trial).
p.000005: Good Clinical Practice (GCP)
p.000005: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000005: trials that provides assurance that the data and reported results are
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
p.000006: Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data
p.000006: Monitoring Committee)
p.000006: An independent data-monitoring committee that may be established by the sponsor to assess at intervals the
...
p.000008: Principal Investigator / Investigator The person responsible for the conduct of the clinical trial at the clinical
p.000008: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000008: located.
p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
p.000009: the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the
p.000009: applicable regulatory requirement(s).
p.000009: Quality Control (QC)
p.000009: The operational techniques and activities undertaken within the quality assurance system to verify that the
p.000009: requirements for quality of the trial-related activities have been fulfilled.
p.000009: Randomization
p.000009: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the
p.000009: assignments in order to reduce bias.
p.000009: Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
p.000009: Any untoward medical occurrence that at any dose:
p.000009: - results in death,
p.000009: - is life-threatening,
p.000009: - requires inpatient hospitalization or prolongation of existing hospitalization,
p.000009: - results in persistent or significant disability/incapacity, or
p.000009: - is a congenital anomaly/birth defect
p.000009: (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
p.000009: Source Data
p.000009: All information in original records and certified copies of original records of clinical findings,
p.000009: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000009: Source data are contained in source documents (original records or certified copies).
p.000009: Source Documents
p.000009: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes,
p.000009: memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from
p.000009: automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches,
p.000009: photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
p.000009: laboratories and at medico-technical departments involved in the clinical trial).
p.000009: Sponsor
p.000009: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000009: management, and/or financing of a clinical trial.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: Sponsor-Investigator
p.000010: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate
p.000010: direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include
p.000010: any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a
p.000010: sponsor-investigator include both those of a sponsor and those of an investigator.
p.000010: Standard Operating Procedures (SOPs)
p.000010: Detailed, written instructions to achieve uniformity of the performance of a specific function.
p.000010: Sub investigator
p.000010: Any individual member of the clinical trial team designated and supervised by the investigator at a
p.000010: trial site to perform critical trial-related procedures and/or to make important trial-related decisions
p.000010: (e.g., associates, residents, research fellows). See also Investigator.
p.000010: Subject/Trial Subject
p.000010: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a
p.000010: control.
p.000010: Subject Identification Code
p.000010: A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in
p.000010: lieu of the subject's name when the investigator reports adverse events and/or other trial related data.
p.000010: Trial Site
p.000010: The location(s) where trial-related activities are actually conducted.
p.000010: Unexpected Adverse Drug Reaction
p.000010: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
p.000010: Investigator's Brochure for an unapproved investigational product or package insert/summary of product
p.000010: characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and
p.000010: Standards for Expedited Reporting).
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
...
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
p.000011: The guideline was partly derived from the International Conference on Harmonization Good Clinical Practice
p.000011: (ICH E6(R2) GCP), World Health Organization (WHO) Guidelines for Good Clinical Practices for Trials on
p.000011: Pharmaceutical Products and from the International Ethical Guidelines for Biomedical Research involving
p.000011: human subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS) in
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: collaboration with World Health Organization (WHO 2002).
p.000012:
p.000012: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical investigators,
p.000012: industry/sponsors/monitors, institutions/ethics committees, and government regulators. The Guidelines are therefore
p.000012: addressed to investigators, pharmaceutical, manufacturers and other sponsors of research, the general public and
p.000012: all, those who have an interest in clinical trials research in Sierra Leone.
p.000012: The guidelines are also applicable to academic and contract clinical research and are intended to be
p.000012: applied during all stages of drug development including pre and post product registration and marketing, and they are
p.000012: also applicable, in whole or in part to biomedical research in general. They also provide a resource for editors to
p.000012: determine the acceptability of reported research for publication and specifically, on any study that could influence
p.000012: the use or the terms of registration of a pharmaceutical product.
p.000012: 1.1 RATIONAL FOR THIS GUIDELINE?
p.000012:
p.000012: The purpose of this guideline is to provide Sierra Leone with clearly articulated standards of good clinical practice
p.000012: in research that are also relevant to local realities and contexts and to ensure that clinical trials conducted on
p.000012: human participants are designed and conducted according to sound scientific and ethical standards within the framework
p.000012: of good clinical practice. Compliance with these standards provides the public with assurance that the
p.000012: rights, safety and wellbeing of trial participants are protected and that clinical trial data are credible.
p.000012: 1.2 PRINCIPLES
p.000012:
p.000012: Although well-designed clinical trials will undoubtedly fit in within these modern ethical sentiments, the potential to
p.000012: violate the rights of trial participants particularly in vulnerable communities necessitates the need to articulate
p.000012: ethical guidelines for clinical trials.
p.000012: The principles of GCP include:
p.000012:
p.000012: 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
p.000012: Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
...
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
p.000016: appropriate for the local setting and that particular modifications are made to the local study when required e.g.
p.000016: inclusion/exclusion criteria. Special attention should also be paid to the sampling strategy when reviewing
p.000016: multi- centred clinical trials.
p.000016: Furthermore, it is unacceptable for developed country participants to have better standards of care offered
p.000016: in the study when compared to Sierra Leone participants. When Sierra Leone is chosen for a clinical trial while the
p.000016: trial is not undertaken in the
p.000016:
p.000017: 17
p.000017:
p.000017: country of origin an explanation should be sought about why this is the case.
p.000017:
p.000017: 1.3 SCOPE OF THIS GUIDELINE
p.000017:
p.000017: This guideline focuses on the management and regulation of drug trials on human participants. These
p.000017: guidelines have not specifically addressed clinical trials on complementary medicines, traditional
p.000017: medicines, non-pharmacological interventions including surgical procedures, medical devices and X-rays. However,
p.000017: this guideline is such that, in the absence of alternatives, the basic principles outlined in this document may be used
p.000017: to guide any research involving human participants, particularly research involving experimental study designs. This
p.000017: guideline has been guided by and based on the following documents:
p.000017: • ICH GCP (R2)
p.000017: • Declaration of Helsinki
p.000017: • International Guidelines for Ethical Review of Epidemiological Studies, Council for International Organisations of
p.000017: Medical Sciences (CIOMS), 1991
p.000017: • World Health Organisation, WHO Technical Report Series, No. 850, Guidelines for good clinical practice (GCP) for
p.000017: trials on pharmaceutical products, 1995
p.000017: In the event that these Guidelines differ from any of the above texts, these Guidelines will apply. The
p.000017: responsibility for deviation with any of the above documents lies with the authors of these Guidelines.
p.000017: 1.4 GUIDELINES AND LEGISLATION
p.000017:
p.000017: Regulations established in terms of the Pharmacy and Drugs Act of 2001 and the National Medicines Policy of 2012
p.000017: enforces this guideline. Compliance with this guideline is compulsory under the direction of the Pharmacy Board
p.000017: of Sierra Leone.
p.000017: 1.5 REGULATORY AUTHORITIES ROLES AND RESPONSIBILITIES
p.000017:
p.000017: This document outlines the roles and responsibilities of the various parties involved in controlling
p.000017: clinical trials in Sierra Leone. Specifically, these include:
...
p.000017: PBSL. The PBSL has a statutory obligation to ensure that the medicines available in the country fulfil the
p.000017: necessary requirements for safety, quality and efficacy. In the case of an ongoing trial where there are serious
p.000017: breaches of Good Clinical Practice (GCP), the PBSL can terminate the trial.
p.000017:
p.000018: 18
p.000018:
p.000018: 1.5.2 Research Ethics Committee: The main responsibility of Research Ethics Committee (REC) in Sierra Leone is
p.000018: to ensure the protection of, and respect the rights, safety and wellbeing of participants involved in a trial and to
p.000018: provide public assurance of that protection by reviewing, approving and providing comment on clinical trial protocols,
p.000018: the suitability of investigator(s), facilities, methods and procedures used to obtain informed consent. In the
p.000018: execution of these responsibilities, the committee should be guided by relevant Sierra Leone ethical guidelines,
p.000018: professional standards and codes of practice.
p.000018: 1.5.3 The Principal Investigator (PI): The principal investigator should be Sierra Leonean- based scientist who has
p.000018: a sole or joint responsibility for the design, conduct, delegation of trial responsibilities, analysis and reporting
p.000018: of the trial. The principal investigator is accountable to the sponsor and regulatory authorities as required by this
p.000018: Guideline. The PI should be knowledgeable and have an understanding of the drug, its toxicology and safety. In the case
p.000018: of a multi-centre trial there must be a local principal investigator (PI) attached to each site. It is unacceptable to
p.000018: have an "absentee" PI who is based in another country. See glossary for
p.000018: definitions of investigator/sub-investigator.
p.000018: 1.5.4 The Sponsor: An individual, company, institution, or organisation which takes responsibility for the initiation,
p.000018: management, and/or financing of a clinical trial.
p.000018: 1.5.7 The Monitor: The monitor is appointed by and reports to the sponsor. The monitor is responsible for
p.000018: overseeing the progress of a clinical trial and ensuring that it is conducted, recorded and reported in
p.000018: accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good
p.000018: Laboratory Practice (GLP), Good Pharmacy Practice (GPP), this guideline and other applicable legislation and
p.000018: regulations.
p.000018: 1.5.8 The Auditor: The auditors are independent individuals appointed by sponsors, local and other regulatory
p.000018: authority(ies) to conduct a systematic and in-depth examination of trial conduct and compliance with the
p.000018: protocol, SOPs, GCP, GLP, GPP and the applicable regulatory requirements. An audit is separate from routine
p.000018: monitoring or quality control functions.
p.000018: 1.5.9 The Inspector: The inspector is a qualified employee of local and international regulatory authority(ies)
p.000018: whose responsibility is to conduct announced or unannounced inspection visits at clinical trial
p.000018: sites/sponsors/CROs/bioequivalence facilities and research ethics committees as required/instructed by the
p.000018: regulatory authority(ies). Most inspectorate visits will be prearranged but some will not especially where
p.000018: there is suspected serious breaches of the GCP or malpractices.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 1.6 CLINICAL TRIAL APPROVAL IN SIERRA LEONE
p.000019:
p.000019: The following steps must be undertaken before a clinical trial can be conducted in Sierra Leone:
p.000019: • PBSL Approval: A sponsor/principal investigator (PI) must apply to the PBSL for approval to conduct a trial for a
p.000019: non-registered drug or a registered drug for new indications etc;
p.000019: • SLERSC Approval: All clinical trials to be conducted in Sierra Leone must apply for and receive ethical approval
p.000019: from the ethics committee
p.000019: 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000019: 3.1 RESPONSIBILITIES
p.000019: 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be
p.000019: paid to trials that may include vulnerable subjects.
p.000019: 3.1.2 The IRB/IEC should obtain the following documents:
p.000019:
p.000019: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator
p.000019: proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be
p.000019: provided to subjects, Investigator's Brochure (IB), available safety information, information about payments
p.000019: and compensation available to subjects, the investigator’s current curriculum vitae and/or other
p.000019: documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its
p.000019: responsibilities.
p.000019: The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly
p.000019: identifying the trial, the documents reviewed and the dates for the following:
p.000019: - approval/favourable opinion;
p.000019: - modifications required prior to its approval/favourable opinion;
...
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
p.000027: • A majority of the research ethics committee, other than prison members, shall have no association with the
...
p.000037: investigator/institution should take measures to prevent accidental or premature destruction of these
p.000037: documents.
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038: 4.9.6 The financial aspects of the trial should be documented in an agreement between the sponsor and the
p.000038: investigator/institution.
p.000038: 4.9.7 Upon request of the PBSL the investigator/institution should make available for direct access all
p.000038: requested trial-related records.
p.000038: 4.10 Progress Reports
p.000038: 4.10.1 The investigator should submit written summaries of the trial status to the PBSL as specified in section 3.5
p.000038: sub-section 3.5.1 of PBSL guideline for conducting clinical trial., or more frequently, if requested by the PBSL.
p.000038: 4.10.2 The investigator should promptly provide written reports to PBSL on any changes significantly affecting the
p.000038: conduct of the trial, and/or increasing the risk to subjects.
p.000038: 4.11 Safety Reporting
p.000038: 4.11.1 All serious adverse events (SAEs) should be reported immediately to PBSL except for those SAEs that the protocol
p.000038: or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate
p.000038: reports should be followed promptly by detailed, written reports. The immediate and follow-up reports
p.000038: should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects'
p.000038: names, personal identification numbers, and/or addresses. The investigator should also comply with the
p.000038: applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to PBSL.
p.000038: See PBSL guideline for conducting clinical trials for timelines.
p.000038: 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations
p.000038: should be reported to the PBSL according to the reporting requirements and within the timelines specified PBSL.
p.000038: 4.11.3 For reported deaths, the investigator should supply PBSL with any additional requested information
p.000038: (e.g., autopsy reports and terminal medical reports).
p.000038: 4.12 Premature Termination or Suspension of a Trial
p.000038: If the trial is prematurely terminated or suspended for any reason, the
p.000038: investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for
p.000038: the subjects, and also inform PBSL. In addition:
p.000038: 4.12.1 If the investigator terminates or suspends a trial without prior agreement of the sponsor, the
p.000038: investigator should inform the institution where applicable, and the investigator/institution should promptly inform
p.000038: the sponsor and PBSL and should provide the sponsor and PBSL a detailed written explanation of the termination or
p.000038: suspension.
p.000038:
p.000039: 39
p.000039:
p.000039: 4.12.2 If the sponsor terminates or suspends a trial (see sub-section 5.21), the investigator should promptly inform
p.000039: the institution where applicable and the investigator/institution should promptly inform PBSL and provide PBSL
p.000039: a detailed written explanation of the termination or suspension.
p.000039: 4.12.3 If the PBSL terminates or suspends its approval of a trial (see subsections 3.1.2 and 3.3.9), the investigator
...
p.000046: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications,
p.000046: should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000046: extent stability permits, samples should be retained either until the analyses of the trial data are complete or as
p.000046: required by the PBSL regulatory requirement(s), whichever represents the longer retention period.
p.000046: 5.15 Record Access
p.000046: 5.15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000046: the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring,
p.000046: audits, PBSL review and regulatory inspection.
p.000046: 5.15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her
p.000046: original medical records for trial-related monitoring, audit, PBSL review, and regulatory inspection.
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 5.16 Safety Information
p.000047: 5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000047: 5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and PBSL of findings that
p.000047: could affect adversely the safety of subjects, impact the conduct of the trial, or alter the PBSL approval to
p.000047: continue the trial.
p.000047: 5.17 Adverse Drug Reaction Reporting
p.000047: 5.17.1 The sponsor should expedite the reporting to PBSL, all concerned
p.000047: investigator(s)/institutions(s), to the IRB(s)/IEC(s),of all adverse drug reactions (ADRs) that are both serious
p.000047: and unexpected.
p.000047: 5.17.2 Such expedited reports should comply with the PBSL regulatory requirement(s) as specified in PBSL guidelines for
p.000047: conducting clinical trials.
p.000047: 5.17.3 The sponsor should submit to PBSL all safety updates and periodic reports, as required by PBSL
p.000047: regulatory requirement(s).
p.000047: 5.18 Monitoring
p.000047: 5.18.1 Purpose
p.000047: The purposes of trial monitoring are to verify that:
p.000047: (a) The rights and well-being of human subjects are protected.
p.000047: (b) The reported trial data are accurate, complete, and verifiable from source documents.
p.000047: (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with
p.000047: GCP, and with the applicable regulatory requirement(s).
p.000047: 5.18.2 Selection and Qualifications of Monitors
p.000047: (a) Monitors should be appointed by the sponsor.
p.000047: (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to
p.000047: monitor the trial adequately. A monitor’s qualifications should be documented.
p.000047: (c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent
p.000047: form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the PBSL regulatory
p.000047: requirement(s).
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: 5.18.3 Extent and Nature of Monitoring
p.000048: The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the
p.000048: appropriate extent and nature of monitoring. The determination of the extent and nature of
...
p.000057: sponsor, and inspection by domestic and foreign
p.000057:
p.000058: 58
p.000058:
p.000058: regulatory authorities.
p.000058: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have
p.000058: been processed correctly. Agreements, made by the sponsor with the principal investigator and any other parties
p.000058: involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.
p.000058: 6.12 Ethics
p.000058: Description of ethical considerations relating to the trial.
p.000058: 6.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000058: given to patients or volunteers.
p.000058: 6.12.2. In all circumstances provisions made in this guideline with respect to ethics and informed consent should be
p.000058: complied with.
p.000058:
p.000058:
p.000058: 6.13 Data Handling and Record Keeping
p.000058: 6.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on the case
p.000058: report form (CRF) for each individual taking part in the trial.
p.000058: 6.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000058: 6.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of
p.000058: 5 years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily
p.000058: available for review upon request by PBSL.
p.000058: 6.14 Financing and Insurance
p.000058: Financing and insurance if not addressed in a separate agreement.
p.000058: 6.15 Publication Policy
p.000058: Publication policy, if not addressed in a separate agreement.
p.000058:
p.000058:
p.000058: 7. INVESTIGATOR’S BROCHURE
p.000058: 7.1 Introduction
p.000058: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational
p.000058: product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the
p.000058: investigators and others involved in the trial with the information to facilitate their understanding of the
p.000058: rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval,
p.000058: methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical
p.000058: management of the study subjects during the course of the clinical trial. The
p.000058:
p.000059: 59
p.000059:
p.000059: information should be presented in a concise, simple, objective, balanced, and non-promotional form
p.000059: that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit
p.000059: assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should
p.000059: generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that
p.000059: generated the described data.
p.000059: This guideline delineates the minimum information that should be included in an IB and provides suggestions for its
...
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
p.000063: − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
p.000063:
p.000063:
p.000063: (b) Safety and Efficacy
p.000063: A summary of information should be provided about the investigational product's/products' (including
p.000063: metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were
p.000063: obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of
p.000063: this information should be discussed. In cases where a number of clinical trials have been completed, the use
p.000063: of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear
p.000063: presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those
p.000063: for all the studied indications) would be useful. Important differences in adverse drug reaction
p.000063: patterns/incidences across indications or subgroups should be discussed.
p.000063: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on
p.000063: the basis of prior experiences with the product under investigation and with related products. A description
p.000063: should also be provided of the precautions or special monitoring to be done as part of the
p.000063: investigational use of the product(s).
p.000063: (c) Marketing Experience
p.000063: The IB should identify countries where the investigational product has been marketed or approved. Any significant
p.000063: information arising from the marketed use should be summarised (e.g., formulations, dosages,
p.000063: routes of administration, and adverse product reactions). The IB should also identify all the countries where
p.000063: the investigational product did not receive approval/registration for marketing or
p.000063: was withdrawn from marketing/registration.
p.000063: 7.3.7 Summary of Data and Guidance for the Investigator
p.000063: This section should provide an overall discussion of the nonclinical and clinical data, and should summarise the
p.000063: information from various sources on different aspects of the investigational product(s), wherever possible.
p.000063: In this way, the investigator can be provided with the most informative interpretation of the available
p.000063: data and with an assessment of the implications of the information for future clinical trials.
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064: Where appropriate, the published reports on related products should be discussed. This could help the investigator
p.000064: to anticipate adverse drug reactions or other problems in clinical trials.
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000065: 65
p.000065:
p.000065: 7.4 APPENDIX 1:
p.000065: TITLE PAGE (Example)
p.000065: SPONSOR'S NAME
p.000065: Product:
p.000065: Research Number:
p.000065: Name(s): Chemical, Generic (if approved)
p.000065: Trade Name(s) (if legally permissible and desired by the sponsor)
p.000065: INVESTIGATOR'S BROCHURE
p.000065: Edition Number:
p.000065: Release Date:
p.000065: Replaces Previous Edition Number: Date:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: 7.5 APPENDIX 2:
p.000066: TABLE OF CONTENTS OF INVESTIGATOR'S BROCHURE (Example)
p.000066: - Confidentiality Statement (optional)...........................................................................
p.000066: - Signature Page
p.000066: (optional).............................................................................................
p.000066: 1 Table of Contents
...
p.000076: subject and substantiate integrity of trial data collected. To include original documents related to the trial, to
p.000076: medical treatment, and history of subject
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077:
p.000077: NO. Title of Document Purpose
p.000077: Located in File
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: 34. SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)
p.000077:
p.000077: 35. DOCUMENTATION OF CRF CORRECTIONS
p.000077:
p.000077:
p.000077:
p.000077: To document that the investigator or authorised member of the
p.000077: investigator’s staff confirms the observations recorded
p.000077:
p.000077: To document all changes/additions or corrections made to CRF after initial data were recorded
p.000077: Investigator/ Institution
p.000077: X
p.000077: (copy)
p.000077:
p.000077:
p.000077: X
p.000077: (copy)
p.000077: Sponsor
p.000077:
p.000077:
p.000077: X
p.000077: (original)
p.000077:
p.000077:
p.000077: X
p.000077: (original)
p.000077:
p.000077:
p.000077: 36. NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
p.000077: Notification by originating X X investigator to sponsor of serious
p.000077: adverse events and related reports in accordance with 4.11of this Guideline for GCP and 3.4 of PBSL Guideline for
p.000077: Conducting Clinical Trials.
p.000077:
p.000077:
p.000077: 37. NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO PBSL AND IRB(S)/IEC(S) OF UNEXPECTED
p.000077: SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION
p.000077: Notification by sponsor and/or investigator, where applicable, to PBSL and IRB(s)/IEC(s) of unexpected serious adverse
p.000077: drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in accordance with
p.000077: 5.16.2 and 4.11.2 of this GCP Guideline.
p.000077: X X
p.000077: (where required)
p.000077:
p.000077:
p.000077: 38. NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
p.000077:
p.000077: 39. INTERIM OR ANNUAL REPORTS TO IRB/IEC AND PBSL
p.000077: Notification by sponsor to investigators of safety information in accordance with 5.16.2 of this Guideline.
p.000077:
p.000077: Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to PBSL) in accordance with
p.000077: 5.17.3 of this Guideline.
p.000077: X X
p.000077:
p.000077:
p.000077:
p.000077: X X
p.000077: (where required)
p.000077:
p.000077:
p.000077:
p.000077:
p.000077:
p.000078: 78
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: NO. Title of Document Purpose
p.000078: Located in File
p.000078:
p.000078: Investigator/ Institution
p.000078: Sponsor
p.000078:
p.000078: 40. SUBJECT SCREENING LOG
p.000078:
p.000078:
p.000078: 41. SUBJECT IDENTIFICATION CODE LIST
p.000078:
p.000078:
p.000078:
p.000078:
p.000078: 42. SUBJECT ENROLMENT LOG
p.000078:
p.000078: 43. INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE
p.000078: To document identification of subjects who entered pre-trial screening
p.000078:
p.000078: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers
p.000078: on enrolling in the trial. Allows investigator/institution to reveal identity of any subject
p.000078:
p.000078: To document chronological enrolment of subjects by trial number
p.000078:
...
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p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
p.000011: The guideline was partly derived from the International Conference on Harmonization Good Clinical Practice
p.000011: (ICH E6(R2) GCP), World Health Organization (WHO) Guidelines for Good Clinical Practices for Trials on
p.000011: Pharmaceutical Products and from the International Ethical Guidelines for Biomedical Research involving
p.000011: human subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS) in
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: collaboration with World Health Organization (WHO 2002).
p.000012:
p.000012: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical investigators,
p.000012: industry/sponsors/monitors, institutions/ethics committees, and government regulators. The Guidelines are therefore
p.000012: addressed to investigators, pharmaceutical, manufacturers and other sponsors of research, the general public and
p.000012: all, those who have an interest in clinical trials research in Sierra Leone.
p.000012: The guidelines are also applicable to academic and contract clinical research and are intended to be
p.000012: applied during all stages of drug development including pre and post product registration and marketing, and they are
p.000012: also applicable, in whole or in part to biomedical research in general. They also provide a resource for editors to
p.000012: determine the acceptability of reported research for publication and specifically, on any study that could influence
p.000012: the use or the terms of registration of a pharmaceutical product.
p.000012: 1.1 RATIONAL FOR THIS GUIDELINE?
p.000012:
p.000012: The purpose of this guideline is to provide Sierra Leone with clearly articulated standards of good clinical practice
p.000012: in research that are also relevant to local realities and contexts and to ensure that clinical trials conducted on
p.000012: human participants are designed and conducted according to sound scientific and ethical standards within the framework
p.000012: of good clinical practice. Compliance with these standards provides the public with assurance that the
p.000012: rights, safety and wellbeing of trial participants are protected and that clinical trial data are credible.
p.000012: 1.2 PRINCIPLES
p.000012:
p.000012: Although well-designed clinical trials will undoubtedly fit in within these modern ethical sentiments, the potential to
p.000012: violate the rights of trial participants particularly in vulnerable communities necessitates the need to articulate
p.000012: ethical guidelines for clinical trials.
p.000012: The principles of GCP include:
p.000012:
p.000012: 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
p.000012: Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
p.000012: 2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000012: benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated
p.000012: benefits justify the risks.
p.000012: 3) The rights, safety, and well-being of the trial subjects are the most important considerations and
p.000012: should prevail over interests of science and society.
p.000012:
...
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
p.000016: appropriate for the local setting and that particular modifications are made to the local study when required e.g.
p.000016: inclusion/exclusion criteria. Special attention should also be paid to the sampling strategy when reviewing
p.000016: multi- centred clinical trials.
p.000016: Furthermore, it is unacceptable for developed country participants to have better standards of care offered
p.000016: in the study when compared to Sierra Leone participants. When Sierra Leone is chosen for a clinical trial while the
p.000016: trial is not undertaken in the
p.000016:
p.000017: 17
p.000017:
p.000017: country of origin an explanation should be sought about why this is the case.
p.000017:
p.000017: 1.3 SCOPE OF THIS GUIDELINE
p.000017:
p.000017: This guideline focuses on the management and regulation of drug trials on human participants. These
...
p.000033: 4.8.1 In obtaining and documenting informed consent, the investigator should comply with the applicable
p.000033: regulatory requirement(s) such as PBSL requirements and should adhere to GCP and to the ethical principles
p.000033: that have their origin in the Declaration of Helsinki(see Appendix 3 of this Guideline). Prior to the beginning
p.000033: of the trial, the investigator should have the IRB/IEC's written approval/favourable opinion of the written informed
p.000033: consent form and any other written information to be provided to subjects.
p.000033: 4.8.2 The written informed consent form and any other written information to be provided to subjects should be
p.000033: revised whenever important new information becomes available that may be relevant to the subject’s
p.000033: consent. Any revised written informed consent form, and written information should receive PBSL approval in advance
p.000033: of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner
p.000033: if new information becomes available that may be relevant to the subject’s willingness to continue participation in the
p.000033: trial. The communication of this information should be documented.
p.000033: 4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a
p.000033:
p.000034: 34
p.000034:
p.000034: subject to participate or to continue to participate in a trial.
p.000034: 4.8.4 None of the oral and written information concerning the trial, including the written informed consent form,
p.000034: should contain any language that causes the subject or the subject's legally acceptable representative to waive or to
p.000034: appear to waive any legal rights, or that releases or appears to release the investigator, the institution,
p.000034: the sponsor, or their agents from liability for negligence.
p.000034: 4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject
p.000034: is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the
p.000034: trial including the written information and the approval by PBSL.
p.000034: 4.8.6 The language used in the oral and written information about the trial, including the written informed consent
p.000034: form, should be as non-technical as practical and should be understandable to the subject or the subject's legally
p.000034: acceptable representative and the impartial witness, where applicable.
p.000034: 4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator, should
p.000034: provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire
p.000034: about details of the trial and to decide whether or not to participate in the trial. All questions about the trial
...
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p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
p.000005: of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors)
p.000005: with direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000005: requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
p.000005: “Drug/Medicine” Includes
p.000005:
p.000005: 1. A substance or mixture of substances prepared, sold or represented for use in
p.000005:
p.000005: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000005:
p.000005: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical state or the symptoms
p.000005: of it, in man or animal, or
p.000005: 2. Nutritional supplements
p.000005:
p.000005: Documentation
p.000005: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and
p.000005: scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a
p.000005: trial, the factors affecting a trial, and the actions taken.
p.000005: Essential Documents
p.000005: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data
p.000005: produced (see Essential Documents for the Conduct of a Clinical Trial).
p.000005: Good Clinical Practice (GCP)
p.000005: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000005: trials that provides assurance that the data and reported results are
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
p.000006: Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data
p.000006: Monitoring Committee)
p.000006: An independent data-monitoring committee that may be established by the sponsor to assess at intervals the
p.000006: progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor
p.000006: whether to continue, modify, or stop a trial.
p.000006: Impartial Witness
...
p.000021: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
...
p.000024: obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and
p.000024: have given their informed consent, except that the father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Individuals engaged in the activity will have no part in (1) any decision as to the timing, method
p.000025: and procedures used to terminate the pregnancy, and/or (2) determining the viability of the foetus at
p.000025: the termination of the pregnancy.
p.000025: No procedural changes, which may cause greater than minimal risk to the foetus or the pregnant woman, will be
p.000025: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
...
p.000059: 7.2.2 Confidentiality Statement
p.000059: The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential
p.000059: document for the sole information and use of the investigator's team and the IRB/IEC.
p.000059: 7.3 Contents of the Investigator’s Brochure
p.000059: The IB should contain the following sections, each with literature references where
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: appropriate:
p.000060: 7.3.1 Table of Contents
p.000060: An example of the Table of Contents is given in Appendix 2
p.000060: 7.3.2 Summary
p.000060: A brief summary (preferably not exceeding two pages) should be given, highlighting the significant
p.000060: physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical
p.000060: information available that is relevant to the stage of clinical development of the investigational product.
p.000060: 7.3.3 Introduction
p.000060: A brief introductory statement should be provided that contains the chemical name (and generic and trade name(s) when
p.000060: approved) of the investigational product(s), all active ingredients, the investigational product (s) pharmacological
p.000060: class and its expected position within this class (e.g. advantages), the rationale for performing research with the
p.000060: investigational product(s), and the anticipated prophylactic, therapeutic, or diagnostic indication(s). Finally,
p.000060: the introductory statement should provide the general approach to be followed in evaluating the
p.000060: investigational product.
p.000060: 7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation
p.000060: A description should be provided of the investigational product substance(s) (including the chemical and/or
p.000060: structural formula(e)), and a brief summary should be given of the relevant physical, chemical, and pharmaceutical
p.000060: properties.
p.000060: To permit appropriate safety measures to be taken in the course of the trial, a description of the
p.000060: formulation(s) to be used, including excipients, should be provided and justified if clinically relevant.
p.000060: Instructions for the storage and handling of the dosage form(s) should also be given.
p.000060: Any structural similarities to other known compounds should be mentioned.
p.000060: 7.3.5 Nonclinical Studies Introduction:
p.000060: The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic,
p.000060: and investigational product metabolism studies should be provided in summary form. This summary should
p.000060: address the methodology used, the results, and a discussion of the relevance of the findings to the investigated
p.000060: therapeutic and the possible unfavourable and unintended effects in humans.
p.000060: The information provided may include the following, as appropriate, if known/available:
p.000060: • Species tested
p.000060:
p.000061: 61
p.000061:
p.000061: • Number and sex of animals in each group
p.000061: • Unit dose (e.g., milligram/kilogram (mg/kg))
p.000061: • Dose interval
p.000061: • Route of administration
p.000061: • Duration of dosing
p.000061: • Information on systemic distribution
p.000061: • Duration of post-exposure follow-up
p.000061: • Results, including the following aspects:
p.000061: − Nature and frequency of pharmacological or toxic effects
p.000061:
p.000061: − Severity or intensity of pharmacological or toxic effects
p.000061:
p.000061: − Time to onset of effects
p.000061:
p.000061: − Reversibility of effects
p.000061:
p.000061: − Duration of effects
p.000061:
...
Health / HIV/AIDS
Searching for indicator HIV:
(return to top)
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000022: performance of routine medical or psychological examinations or tests – referred to as 'negligible risk' in some
p.000022: guidelines); or
...
Health / Healthy People
Searching for indicator volunteers:
(return to top)
p.000057: investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and PBSL
p.000057: regulatory inspection(s), providing direct access to source data/documents.
p.000057: 6.11 Quality Control and Quality Assurance
p.000057: 6.11.1. The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with
p.000057: written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are generated,
p.000057: documented (recorded), and reported in compliance with the protocol, GCP, and PBSL regulatory requirement(s).
p.000057: 4.11.2. The sponsor is responsible for securing agreement from all involved parties to ensure direct access
p.000057: to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the
p.000057: sponsor, and inspection by domestic and foreign
p.000057:
p.000058: 58
p.000058:
p.000058: regulatory authorities.
p.000058: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have
p.000058: been processed correctly. Agreements, made by the sponsor with the principal investigator and any other parties
p.000058: involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.
p.000058: 6.12 Ethics
p.000058: Description of ethical considerations relating to the trial.
p.000058: 6.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000058: given to patients or volunteers.
p.000058: 6.12.2. In all circumstances provisions made in this guideline with respect to ethics and informed consent should be
p.000058: complied with.
p.000058:
p.000058:
p.000058: 6.13 Data Handling and Record Keeping
p.000058: 6.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on the case
p.000058: report form (CRF) for each individual taking part in the trial.
p.000058: 6.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000058: 6.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of
p.000058: 5 years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily
p.000058: available for review upon request by PBSL.
p.000058: 6.14 Financing and Insurance
p.000058: Financing and insurance if not addressed in a separate agreement.
p.000058: 6.15 Publication Policy
p.000058: Publication policy, if not addressed in a separate agreement.
p.000058:
p.000058:
p.000058: 7. INVESTIGATOR’S BROCHURE
p.000058: 7.1 Introduction
p.000058: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational
p.000058: product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the
p.000058: investigators and others involved in the trial with the information to facilitate their understanding of the
p.000058: rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval,
...
p.000062: dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each
p.000062: completed clinical trial should be provided. Information should also be provided regarding results of any use of the
p.000062: investigational product(s) other than from in clinical trials, such as from experience during marketing.
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
p.000063: − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
p.000063:
p.000063:
p.000063: (b) Safety and Efficacy
p.000063: A summary of information should be provided about the investigational product's/products' (including
p.000063: metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were
p.000063: obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of
p.000063: this information should be discussed. In cases where a number of clinical trials have been completed, the use
p.000063: of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear
p.000063: presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those
p.000063: for all the studied indications) would be useful. Important differences in adverse drug reaction
p.000063: patterns/incidences across indications or subgroups should be discussed.
p.000063: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on
p.000063: the basis of prior experiences with the product under investigation and with related products. A description
p.000063: should also be provided of the precautions or special monitoring to be done as part of the
p.000063: investigational use of the product(s).
p.000063: (c) Marketing Experience
p.000063: The IB should identify countries where the investigational product has been marketed or approved. Any significant
p.000063: information arising from the marketed use should be summarised (e.g., formulations, dosages,
p.000063: routes of administration, and adverse product reactions). The IB should also identify all the countries where
p.000063: the investigational product did not receive approval/registration for marketing or
p.000063: was withdrawn from marketing/registration.
p.000063: 7.3.7 Summary of Data and Guidance for the Investigator
...
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
p.000083: 6. The physician can combine medical research with professional care, the objective being the acquisition of new
p.000083: medical knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000083: therapeutic value for the patient.
p.000083: III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
p.000084: 84
p.000084:
p.000084: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000084: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000084: out.
p.000084: 2. The subjects should be volunteers--either healthy persons or patients for whom the experimental designed
p.000084: is not related to the patient's illness.
p.000084: 3. The investigator or the investigating team should discontinue the research if in his/her or their judgement it may,
p.000084: if continued, be harmful to the individual.
p.000084: 4. In research on man, the interest of science and society should never take precedence over considerations related to
p.000084: the wellbeing of the subject.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
...
Searching for indicator disability:
(return to top)
p.000008: located.
p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
p.000009: the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the
p.000009: applicable regulatory requirement(s).
p.000009: Quality Control (QC)
p.000009: The operational techniques and activities undertaken within the quality assurance system to verify that the
p.000009: requirements for quality of the trial-related activities have been fulfilled.
p.000009: Randomization
p.000009: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the
p.000009: assignments in order to reduce bias.
p.000009: Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
p.000009: Any untoward medical occurrence that at any dose:
p.000009: - results in death,
p.000009: - is life-threatening,
p.000009: - requires inpatient hospitalization or prolongation of existing hospitalization,
p.000009: - results in persistent or significant disability/incapacity, or
p.000009: - is a congenital anomaly/birth defect
p.000009: (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
p.000009: Source Data
p.000009: All information in original records and certified copies of original records of clinical findings,
p.000009: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000009: Source data are contained in source documents (original records or certified copies).
p.000009: Source Documents
p.000009: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes,
p.000009: memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from
p.000009: automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches,
p.000009: photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
p.000009: laboratories and at medico-technical departments involved in the clinical trial).
p.000009: Sponsor
p.000009: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000009: management, and/or financing of a clinical trial.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: Sponsor-Investigator
p.000010: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate
p.000010: direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include
p.000010: any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a
...
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
p.000011: The guideline was partly derived from the International Conference on Harmonization Good Clinical Practice
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000031: 4.2.5 The investigator is responsible for supervising any individual or party to whom the investigator delegates
p.000031: trial-related duties and functions conducted at the trial site.
p.000031: 4.2.6 If the investigator/institution retains the services of any individual or party to perform trial-related duties
p.000031: and functions, the investigator/institution should ensure this individual or party is qualified to perform those
p.000031: trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties
p.000031: and functions performed and any data generated.
p.000031: 4.3 Medical Care of Trial Subjects
p.000031: 4.3.1 A medical practitioner (or dentist, when appropriate), who is an investigator or a sub-investigator for the
p.000031: trial, should be responsible for all trial-related medical (or dental) decisions. The qualified medical practitioner
p.000031: should also be licensed with the Sierra Leone Medical and Dental Council or the Pharmacy Board of Sierra Leone. The
p.000031: medical care given to, and medical decisions made on behalf of the subjects must always be the
p.000031: responsibility of a qualified medical practitioner or when appropriate a qualified dentist registered with the Medical
p.000031: and Dental Council.
p.000031: 4.3.2 During and following a subject's participation in a trial, the investigator should ensure that adequate medical
p.000031: care is provided to a subject for any adverse events, including clinically significant laboratory values, related to
p.000031: the trial. The investigator should inform a subject when medical care is needed for intercurrent illness(es) of which
p.000031: the investigator becomes aware.
p.000031: 4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation
p.000031: in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
p.000031: 4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a
p.000031: trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the
p.000031: subject's rights.
p.000031:
p.000031:
p.000031: 4.4 Communication with PBSL
p.000031: 4.4.1 Before initiating a trial, the principal investigator should have the written and dated approval from the PBSL
p.000031:
p.000032: 32
p.000032:
p.000032: 4.4.2 As part of the investigator written application to PBSL, the investigator should provide PBSL
p.000032: with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during
p.000032: the trial, the investigator should supply a copy of the updated Investigator’s Brochure to PBSL.
p.000032: 4.4.3 During the trial the investigator should provide PBSL all documents subject to review.
p.000032: 4.5 Compliance with Protocol
p.000032: 4.5.1 The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, which
p.000032: was given approval by PBSL. The investigator and the sponsor should sign the protocol, or an alternative
p.000032: contract, to confirm agreement.
p.000032: 4.5.2 The investigator should not implement any deviation from, or changes of the protocol without prior review and
p.000032: approval from PBSL of an amendment, except where necessary to eliminate an immediate hazard(s) to trial
...
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
p.000083: 6. The physician can combine medical research with professional care, the objective being the acquisition of new
p.000083: medical knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000083: therapeutic value for the patient.
p.000083: III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
p.000084: 84
p.000084:
p.000084: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000084: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000084: out.
p.000084: 2. The subjects should be volunteers--either healthy persons or patients for whom the experimental designed
p.000084: is not related to the patient's illness.
p.000084: 3. The investigator or the investigating team should discontinue the research if in his/her or their judgement it may,
p.000084: if continued, be harmful to the individual.
p.000084: 4. In research on man, the interest of science and society should never take precedence over considerations related to
p.000084: the wellbeing of the subject.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
...
Health / Physically Ill
Searching for indicator sick:
(return to top)
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
p.000083: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
p.000083: 6. The physician can combine medical research with professional care, the objective being the acquisition of new
p.000083: medical knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000083: therapeutic value for the patient.
p.000083: III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
p.000084: 84
p.000084:
p.000084: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000084: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000084: out.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
p.000023: women's health. Research ethics committees should consider whether the exclusion of women is justified in terms of
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
p.000023: perpetuate discriminations against women by unfairly or unjustifiably excluding them from study protocols.
p.000023: 3.4.2.1 Women and Pregnancy: Research ethics committees must give extra attention to research that involves
p.000023: women who are, or may become pregnant, because of the additional health concerns during pregnancy and the need to avoid
p.000023: unnecessary risk to the foetus. Reasons for excluding women from research should be adequately justified both from
p.000023: the point of protecting the health of a foetus and from the perspective of whether such exclusion is
p.000023: scientifically supportable.
p.000023: No research activities involving pregnant women and foetuses may be undertaken unless:
p.000023: • Appropriate studies on animals and non-pregnant individuals have been completed;
p.000023: • The purpose of the activity is to meet the health needs of the mother of the particular foetus, the risk to the
p.000023: foetus is minimal and, in all cases, presents the least possible risk for achieving the objectives of the activity.
p.000023: • Individuals engaged in the activity will have no part in 1) any decision as to the timing, method and
p.000023: procedures used to terminate the pregnancy, and 2) determining the viability of the foetus at the termination of
p.000023: the pregnancy; and
p.000023: • No procedural changes which may cause greater than minimal risk to the foetus or the pregnant woman will be
p.000023: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000023: The father's informed consent need not be secured if:
p.000023: • the purpose of the activity is to meet the health needs of the mother;
p.000023: • his identity or whereabouts cannot reasonably be ascertained;
p.000023: • he is not reasonably available; or
p.000023: • the pregnancy results from rape.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 3.4.2.2 Foetuses In-Utero as Participants: No foetus in utero may be involved as a participant in any research activity
p.000024: unless:
p.000024: • the purpose of the activity is to meet the health needs of the particular foetus and the foetus will be placed at
p.000024: risk only to the minimum extent necessary to meet such needs; or
p.000024: • the risk to the foetus imposed by the research is minimal and the purpose of the activity is the development of
p.000024: important biomedical knowledge which cannot be obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and have
p.000024: given their informed consent.
p.000024: The father's informed consent need not be secured if:
...
p.000024: point of viability.
p.000024: No nonviable foetus may be involved as a participant in any research activity unless:
p.000024: • vital functions of the foetus will not be artificially maintained; experimental activities which of themselves
p.000024: would terminate the heartbeat or respiration of the foetus will not be employed; and
p.000024: • the purpose of the activity is the development of important biomedical knowledge which cannot be
p.000024: obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and
p.000024: have given their informed consent, except that the father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Individuals engaged in the activity will have no part in (1) any decision as to the timing, method
p.000025: and procedures used to terminate the pregnancy, and/or (2) determining the viability of the foetus at
p.000025: the termination of the pregnancy.
p.000025: No procedural changes, which may cause greater than minimal risk to the foetus or the pregnant woman, will be
p.000025: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
...
Health / Terminally Ill
Searching for indicator terminal:
(return to top)
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
...
p.000038: 4.10 Progress Reports
p.000038: 4.10.1 The investigator should submit written summaries of the trial status to the PBSL as specified in section 3.5
p.000038: sub-section 3.5.1 of PBSL guideline for conducting clinical trial., or more frequently, if requested by the PBSL.
p.000038: 4.10.2 The investigator should promptly provide written reports to PBSL on any changes significantly affecting the
p.000038: conduct of the trial, and/or increasing the risk to subjects.
p.000038: 4.11 Safety Reporting
p.000038: 4.11.1 All serious adverse events (SAEs) should be reported immediately to PBSL except for those SAEs that the protocol
p.000038: or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate
p.000038: reports should be followed promptly by detailed, written reports. The immediate and follow-up reports
p.000038: should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects'
p.000038: names, personal identification numbers, and/or addresses. The investigator should also comply with the
p.000038: applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to PBSL.
p.000038: See PBSL guideline for conducting clinical trials for timelines.
p.000038: 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations
p.000038: should be reported to the PBSL according to the reporting requirements and within the timelines specified PBSL.
p.000038: 4.11.3 For reported deaths, the investigator should supply PBSL with any additional requested information
p.000038: (e.g., autopsy reports and terminal medical reports).
p.000038: 4.12 Premature Termination or Suspension of a Trial
p.000038: If the trial is prematurely terminated or suspended for any reason, the
p.000038: investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for
p.000038: the subjects, and also inform PBSL. In addition:
p.000038: 4.12.1 If the investigator terminates or suspends a trial without prior agreement of the sponsor, the
p.000038: investigator should inform the institution where applicable, and the investigator/institution should promptly inform
p.000038: the sponsor and PBSL and should provide the sponsor and PBSL a detailed written explanation of the termination or
p.000038: suspension.
p.000038:
p.000039: 39
p.000039:
p.000039: 4.12.2 If the sponsor terminates or suspends a trial (see sub-section 5.21), the investigator should promptly inform
p.000039: the institution where applicable and the investigator/institution should promptly inform PBSL and provide PBSL
p.000039: a detailed written explanation of the termination or suspension.
p.000039: 4.12.3 If the PBSL terminates or suspends its approval of a trial (see subsections 3.1.2 and 3.3.9), the investigator
p.000039: should inform the institution where applicable and the investigator/institution should promptly notify the
p.000039: sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.
p.000039: 4.13 Final Report(s) by Investigator
p.000039: Upon completion of the trial, the investigator s should provide the PBSL with a summary of the trial’s outcome. See
p.000039: PBSL guidelines for conducting clinical trial for format.
p.000039: 5. SPONSOR
p.000039: 5.0 Quality Management
p.000039: The sponsor should implement a system to manage quality throughout all stages of the trial process. Sponsors should
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
p.000028: the participant's representative is able to give consent in advance, a research ethics committee may approve a research
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
...
Health / alcoholism
Searching for indicator alcoholism:
(return to top)
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
p.000022: minor increase over minimal risk. The intervention or procedure should present experiences to participants that are
p.000022: reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or
p.000022: education settings.
p.000022: • In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as
p.000022: participants.
p.000022:
p.000022: 3.4.1.1 Consent Requirements: For research with minors, the following should be obtained:
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
...
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: • adequate provision will be made for informing patients and their relatives about the research, to ensure that
p.000029: stress and other emotional factors do not impair their understanding of it; and
p.000029: • the dependency of patients and their relatives on the medical personnel providing treatment does not affect any
p.000029: decision to participate.
p.000029: 3.4.7 Emergency Care Research: The benefits of emergency care research include improved effective treatment
p.000029: for life-threatening conditions and improving therapies for survival and quality of life. Research into emergency
p.000029: medical treatment needs to involve participants who are experiencing medical emergencies.
p.000029: The distinguishing feature of emergency care research however is that consent to commence a project usually
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
p.000029: Research ethics committee must therefore take great care when assessing emergency care research.
p.000029: Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to
p.000029: obtain consent for inclusion without delaying the initiation of treatment, and so risking a reduction of
p.000029: potential benefits. As such there may be circumstances in which it is not possible to obtain consent for
p.000029: inclusion in emergency care research. After a protocol has been presented by a researcher giving clear reasons to
p.000029: justify the initiation of the emergency care research without consent, a research ethics committee may approve the
p.000029: research without consent provided it is satisfied that:
p.000029: • reasonable steps are being taken to ascertain the religious and cultural sensitivities of patients experiencing
p.000029: medical emergencies;
p.000029: • the condition of the patient precludes the giving of consent;
p.000029: • inclusion in the trial is not contrary to the interests of the patient;
p.000029: • the research is intended to be therapeutic and poses no more risk than is inherent to the patient's condition or
p.000029: would be caused by alternative methods of treatment;
p.000029: • the patient and the patient's next of kin or legal representatives will be informed as soon as is reasonably
p.000029: possible of the patient's inclusion in the study and of the option to withdraw from the research project at any time;
p.000029: • the patient will be informed, and consent obtained, once the patient who has undergone the necessary
p.000029: emergency procedures has regained consciousness; and
p.000029: • the research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard
p.000029: care.
p.000029:
p.000029:
p.000029:
p.000029: 4. INVESTIGATOR
p.000029: 4.1 Investigator's Qualifications and Agreements
p.000029: 4.1.1 The investigator(s) should be qualified by education, training, and experience to
p.000029:
p.000030: 30
p.000030:
p.000030: assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications and
p.000030: experience through an up to date Curriculum Vitae. The Principal investigator’s qualification should be in
p.000030: accordance with Section 3.2 sub-section 3.2.3 under the PBSL Guidelines for Conducting Clinical Trials.
...
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p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
p.000005: of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors)
p.000005: with direct access should take all reasonable precautions within the constraints of the applicable regulatory
p.000005: requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
p.000005: “Drug/Medicine” Includes
p.000005:
p.000005: 1. A substance or mixture of substances prepared, sold or represented for use in
p.000005:
p.000005: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000005:
p.000005: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical state or the symptoms
p.000005: of it, in man or animal, or
p.000005: 2. Nutritional supplements
p.000005:
p.000005: Documentation
p.000005: All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and
p.000005: scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a
p.000005: trial, the factors affecting a trial, and the actions taken.
p.000005: Essential Documents
p.000005: Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data
p.000005: produced (see Essential Documents for the Conduct of a Clinical Trial).
p.000005: Good Clinical Practice (GCP)
p.000005: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000005: trials that provides assurance that the data and reported results are
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
p.000006: Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data
...
p.000015: and the possible benefits of the effects must be made. The principal investigator has the ethical duty of
p.000015: excluding participants who are at undue risk.
p.000015: 1.2.5 Transparency: Clinical trialists have an ethical obligation to honestly report a trial's existence and findings.
p.000015: Publication bias among other things often serves as a barrier to this and can distort the body of evidence
p.000015: available for clinical decision making. That’s why it is a requirement for all trials being conducted in Sierra
p.000015: Leone to be registered in a PBSL approved clinical trial registry preferable the Pan-African Clinical Trial
p.000015: Registry (PACTR).
p.000015: Benefits of registering a trial are numerous. It serves to: promote collaboration among researchers, the private
p.000015: sector and the community through the sharing of research information; assist people to identify clinical trials
p.000015: they can participate in; decrease publication bias; reduce duplication of research efforts; promote best use of limited
p.000015: research resources; and contribute to global efforts to reduce/eliminate disease (while preserving the
p.000015: confidentiality of commercially valuable information regarding the medicine during the development stage).
p.000015: Sponsors of trials conducted in Sierra Leone are required to register their trials. Where there is no sponsor, it is
p.000015: the responsibility of the Principal Investigator to register the trial.
p.000015: 1.2.6 Privacy: Participants' right to privacy must be protected at all costs. This is maintained via the
p.000015: use of appropriate precautions regarding participant identifiers. This will also include
p.000015: electronic/computerised records and access thereof of such information.
p.000015: 1.2.7 Scientific and Ethical Review: Scientific and ethical review provides an objective appraisal of the
p.000015: research proposal as it affects the potential participants and the general day to day functioning of the health
p.000015: system. The following bodies are involved in scientific and ethical review in Sierra Leone:
p.000015: • Sierra Leone Ethical and Scientific Review Committee (SLERSC): Research Ethics Committees are usually made up of
p.000015: medical and non-medical professionals. SLERSC is the national ethics committee which advises the Ministry of Health and
p.000015: Sanitation on health research ethics in Sierra Leone. All clinical trials conducted in Sierra Leone must undergo
p.000015: ethical review SLERSC.
p.000015:
p.000016: 16
p.000016:
p.000016: • Data and Safety Monitoring Committees: These committees oversee ongoing clinical trials with respect to treatment,
p.000016: efficacy and safety. In the advent of clear evidence of efficacy or harm, prior to the end of the trial, premature
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
...
p.000035: information to be provided to subjects should include explanations of the following:
p.000035: (a) That the trial involves research.
p.000035: (b) The purpose of the trial.
p.000035: (c) The trial treatment(s) and the probability for random assignment to each treatment.
p.000035: (d) The trial procedures to be followed, including all invasive procedures.
p.000035: (e) The subject's responsibilities.
p.000035: (f) Those aspects of the trial that are experimental.
p.000035: (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
p.000035: nursing infant.
p.000035: (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
p.000035: made aware of this.
p.000035: (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
p.000035: potential benefits and risks.
p.000035: (j) The compensation and/or treatment available to the subject in the event of trial-related injury.
p.000035: (k) The anticipated prorated payment, if any, to the subject for participating in the trial.
p.000035: (l) The anticipated expenses, if any, to the subject for participating in the trial.
p.000035: (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
p.000035: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.000035: (n) That the monitor(s), the auditor(s), the IRB/IEC, and PBSL will be granted direct access to the
p.000035: subject's original medical records for verification of clinical trial procedures and/or data, without violating the
p.000035: confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
p.000035: signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing
p.000035: such access.
p.000035: (o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
p.000035: and/or regulations, will not be made publicly available. If the results of the trial are published, the
p.000035: subject’s identity will remain confidential.
p.000035:
p.000035:
p.000036: 36
p.000036:
p.000036: (p) That the subject or the subject's legally acceptable representative will be informed in a timely
p.000036: manner if information becomes available that may be relevant to the subject's willingness to continue
p.000036: participation in the trial.
p.000036: (q) The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to
p.000036: contact in the event of trial-related injury.
p.000036: (r) The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be
p.000036: terminated.
p.000036: (s) The expected duration of the subject's participation in the trial.
p.000036: (t) The approximate number of subjects involved in the trial.
p.000036: 4.8.11 Prior to participation in the trial, the subject or the subject's legally acceptable representative
p.000036: should receive a copy of the signed and dated written informed consent form and any other written
p.000036: information provided to the subjects. During a subject’s participation in the trial, the subject or the subject’s
p.000036: legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any
p.000036: amendments to the written information provided to subjects.
p.000036: 4.8.12 When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be enrolled in the
...
p.000037: sponsor in the CRFs and in all required reports.
p.000037: 4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the
p.000037: source documents or the discrepancies should be explained.
p.000037: 4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not
p.000037: obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic
p.000037: changes or corrections (see
p.000037: 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated
p.000037: representatives on making such corrections. Sponsors should have written procedures to assure that changes or
p.000037: corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are
p.000037: endorsed by the investigator. The investigator should retain records of the changes and corrections.
p.000037: 4.9.4 The investigator/institution should maintain the trial documents as specified in Essential Documents
p.000037: for the Conduct of a Clinical Trial (see section 11.) and as required by the applicable regulatory requirement(s). The
p.000037: investigator/institution should take measures to prevent accidental or premature destruction of these
p.000037: documents.
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038: 4.9.6 The financial aspects of the trial should be documented in an agreement between the sponsor and the
p.000038: investigator/institution.
p.000038: 4.9.7 Upon request of the PBSL the investigator/institution should make available for direct access all
p.000038: requested trial-related records.
p.000038: 4.10 Progress Reports
p.000038: 4.10.1 The investigator should submit written summaries of the trial status to the PBSL as specified in section 3.5
p.000038: sub-section 3.5.1 of PBSL guideline for conducting clinical trial., or more frequently, if requested by the PBSL.
p.000038: 4.10.2 The investigator should promptly provide written reports to PBSL on any changes significantly affecting the
p.000038: conduct of the trial, and/or increasing the risk to subjects.
p.000038: 4.11 Safety Reporting
p.000038: 4.11.1 All serious adverse events (SAEs) should be reported immediately to PBSL except for those SAEs that the protocol
p.000038: or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate
p.000038: reports should be followed promptly by detailed, written reports. The immediate and follow-up reports
p.000038: should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects'
p.000038: names, personal identification numbers, and/or addresses. The investigator should also comply with the
p.000038: applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to PBSL.
p.000038: See PBSL guideline for conducting clinical trials for timelines.
p.000038: 4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations
p.000038: should be reported to the PBSL according to the reporting requirements and within the timelines specified PBSL.
p.000038: 4.11.3 For reported deaths, the investigator should supply PBSL with any additional requested information
...
p.000040: if action is needed.
p.000040: 5.0.5 Risk Communication
p.000040: The sponsor should document quality management activities. The sponsor should communicate quality
p.000040: management activities to those who are involved in or affected by such activities, to facilitate risk review and
p.000040: continual improvement during clinical trial execution.
p.000040: 5.0.6 Risk Review
p.000040: The sponsor should periodically review risk control measures to ascertain whether the implemented quality
p.000040: management activities remain effective and relevant, taking into account emerging knowledge and experience.
p.000040: 5.0.7 Risk Reporting The sponsor should describe the quality management approach implemented in the trial
p.000040: and summarize important deviations from the predefined quality tolerance limits and remedial actions taken
p.000040: in the clinical study report (ICH E3, Section 9.6 Data Quality Assurance).
p.000040:
p.000040:
p.000040: 5.1 Quality Assurance and Quality Control
p.000040: 5.1.1 The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with
p.000040: written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in
p.000040: compliance with the protocol, GCP, and the PBSL regulatory requirement(s).
p.000040: 5.1.2 The sponsor is responsible for securing agreement from all involved parties to ensure direct access to all trial
p.000040: related sites, source data/documents, and reports for the
p.000040:
p.000041: 41
p.000041:
p.000041: purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities.
p.000041: 5.1.3 Quality control should be applied to each stage of data handling to ensure that all data are reliable and have
p.000041: been processed correctly.
p.000041: 5.1.4 Agreements, made by the sponsor with the investigator/institution and any other parties involved with
p.000041: the clinical trial, should be in writing, as part of the protocol submitted to PBSL or in a separate agreement
p.000041: 5.2 Contract Research Organization (CRO)
p.000041: 5.2.1 A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate
p.000041: responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should
p.000041: implement quality assurance and quality control.
p.000041: 5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified
p.000041: in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its
p.000041: behalf, including trial-related duties and functions that are subcontracted to another party by the
p.000041: sponsor’s contracted CRO(s).
p.000041: 5.2.3 Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the
p.000041: sponsor.
p.000041: 5.2.4 All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial
p.000041: related duties and functions of a sponsor.
p.000041: 5.3 Medical Expertise
...
p.000042: sponsor whether to continue, modify, or stop a trial. The IDMC should have written operating procedures and
p.000042: maintain written records of all its meetings.
p.000042: 5.5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:
p.000042: (a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established
p.000042: requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation). The
p.000042: sponsor should base their approach to validation of such systems on a risk assessment that takes into consideration the
p.000042: intended use of the system and the potential of the system to affect human subject protection and reliability of trial
p.000042: results.
p.000042: (b) Maintains SOPs for using these systems. The SOPs should cover system setup, installation, and use. The SOPs
p.000042: should describe system validation and functionality testing, data collection and handling, system maintenance,
p.000042: system security measures, change control, data backup, recovery, contingency planning, and
p.000042: decommissioning. The responsibilities of the sponsor, investigator, and other parties with respect to the use
p.000042: of these computerized systems should be clear, and the users should be provided with training in their use.
p.000042: (c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and
p.000042: that there is no deletion of entered data (i.e. maintain an audit trail, data trail, edit trail).
p.000042: (d) Maintain a security system that prevents unauthorized access to the data.
p.000042: (e) Maintain a list of the individuals who are authorized to make data changes (see subsections 4.1.5 and 4.9.3).
p.000042: (f) Maintain adequate backup of the data.
p.000042: (g) Safeguard the blinding, if any (e.g. maintain the blinding during data entry and processing).
p.000042: (h) Ensure the integrity of the data including any data that describe the context, content, and structure. This is
p.000042: particularly important when making changes to
p.000042:
p.000043: 43
p.000043:
p.000043: the computerized systems, such as software upgrades or migration of data.
p.000043: 5.5.4 If data are transformed during processing, it should always be possible to compare the original data and
p.000043: observations with the processed data.
p.000043: 5.5.5 The sponsor should use an unambiguous subject identification code that allows identification of all
p.000043: the data reported for each subject.
p.000043: 5.5.6 The sponsor, or other owners of the data, should retain all of the sponsor-specific essential documents
p.000043: pertaining to the trial (see section 11. Essential Documents for the Conduct of a Clinical Trial).
p.000043: 5.5.7 The sponsor should retain all sponsor-specific essential documents in conformance with the applicable regulatory
p.000043: requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends to apply for
p.000043: approval(s).
p.000043: 5.5.8 If the sponsor discontinues the clinical development of an investigational product (i.e. for any or all
p.000043: indications, routes of administration, or dosage forms), the sponsor should maintain all sponsor-specific essential
p.000043: documents for at least 2 years after formal discontinuation or in conformance with the applicable
p.000043: regulatory requirement(s).
...
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: investigational product(s) for the trial and documentation thereof. The procedures should address adequate and safe
p.000046: receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational
p.000046: product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the PBSL
p.000046: regulatory requirement(s)).
p.000046: 5.14.4 The sponsor should:
p.000046: (a) Ensure timely delivery of investigational product(s) to the investigator(s).
p.000046: (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the
p.000046: investigational product(s) (see Section 11. Essential Documents for the Conduct of a Clinical Trial).
p.000046: (c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g. for deficient
p.000046: product recall, reclaim after trial completion, expired product reclaim).
p.000046: (d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this
p.000046: disposition.
p.000046: 5.14.5 The sponsor should:
p.000046: (a) Take steps to ensure that the investigational product(s) are stable over the period of use.
p.000046: (b) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications,
p.000046: should this become necessary, and maintain records of batch sample analyses and characteristics. To the
p.000046: extent stability permits, samples should be retained either until the analyses of the trial data are complete or as
p.000046: required by the PBSL regulatory requirement(s), whichever represents the longer retention period.
p.000046: 5.15 Record Access
p.000046: 5.15.1 The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000046: the investigator(s)/institution(s) provide direct access to source data/documents for trial-related monitoring,
p.000046: audits, PBSL review and regulatory inspection.
p.000046: 5.15.2 The sponsor should verify that each subject has consented, in writing, to direct access to his/her
p.000046: original medical records for trial-related monitoring, audit, PBSL review, and regulatory inspection.
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: 5.16 Safety Information
p.000047: 5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
p.000047: 5.16.2 The sponsor should promptly notify all concerned investigator(s)/institution(s) and PBSL of findings that
p.000047: could affect adversely the safety of subjects, impact the conduct of the trial, or alter the PBSL approval to
p.000047: continue the trial.
p.000047: 5.17 Adverse Drug Reaction Reporting
p.000047: 5.17.1 The sponsor should expedite the reporting to PBSL, all concerned
p.000047: investigator(s)/institutions(s), to the IRB(s)/IEC(s),of all adverse drug reactions (ADRs) that are both serious
p.000047: and unexpected.
p.000047: 5.17.2 Such expedited reports should comply with the PBSL regulatory requirement(s) as specified in PBSL guidelines for
p.000047: conducting clinical trials.
p.000047: 5.17.3 The sponsor should submit to PBSL all safety updates and periodic reports, as required by PBSL
p.000047: regulatory requirement(s).
p.000047: 5.18 Monitoring
p.000047: 5.18.1 Purpose
p.000047: The purposes of trial monitoring are to verify that:
p.000047: (a) The rights and well-being of human subjects are protected.
p.000047: (b) The reported trial data are accurate, complete, and verifiable from source documents.
p.000047: (c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with
p.000047: GCP, and with the applicable regulatory requirement(s).
...
p.000056:
p.000056:
p.000056: 6.7 Assessment of Efficacy
p.000056: 6.7.1 Specification of the efficacy parameters.
p.000056: 6.7.2 Methods and timing for assessing, recording, and analysing of efficacy parameters.
p.000056: 6.8 Assessment of Safety
p.000056: 6.8.1 Specification of safety parameters.
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: 6.8.2 The methods and timing for assessing, recording, and analysing safety parameters.
p.000057: 6.8.3 Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.
p.000057: 6.8.4 The type and duration of the follow-up of subjects after adverse events.
p.000057:
p.000057:
p.000057: 6.9 Statistics
p.000057: 6.9.1 A description of the statistical methods to be employed, including timing of any planned interim
p.000057: analysis(ses).
p.000057: 6.9.2 The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected
p.000057: for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations
p.000057: of) the power of the trial and clinical justification.
p.000057: 6.9.3 The level of significance to be used.
p.000057: 6.9.4 Criteria for the termination of the trial.
p.000057: 6.9.5 Procedure for accounting for missing, unused, and spurious data.
p.000057: 6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from
p.000057: the original statistical plan should be described and justified in protocol and/or in the final report, as
p.000057: appropriate).
p.000057: 6.9.7 The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all
p.000057: eligible subjects, evaluable subjects).
p.000057: 6.10 Direct Access to Source Data/Documents
p.000057: The sponsor should ensure that it is specified in the protocol or other written agreement that the
p.000057: investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and PBSL
p.000057: regulatory inspection(s), providing direct access to source data/documents.
p.000057: 6.11 Quality Control and Quality Assurance
p.000057: 6.11.1. The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with
p.000057: written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are generated,
p.000057: documented (recorded), and reported in compliance with the protocol, GCP, and PBSL regulatory requirement(s).
p.000057: 4.11.2. The sponsor is responsible for securing agreement from all involved parties to ensure direct access
p.000057: to all trial related sites, source data/documents, and reports for the purpose of monitoring and auditing by the
p.000057: sponsor, and inspection by domestic and foreign
p.000057:
p.000058: 58
p.000058:
p.000058: regulatory authorities.
p.000058: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and have
p.000058: been processed correctly. Agreements, made by the sponsor with the principal investigator and any other parties
p.000058: involved with the clinical trial, should be in writing, as part of the protocol or in a separate agreement.
p.000058: 6.12 Ethics
p.000058: Description of ethical considerations relating to the trial.
p.000058: 6.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000058: given to patients or volunteers.
p.000058: 6.12.2. In all circumstances provisions made in this guideline with respect to ethics and informed consent should be
p.000058: complied with.
p.000058:
p.000058:
p.000058: 6.13 Data Handling and Record Keeping
p.000058: 6.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on the case
p.000058: report form (CRF) for each individual taking part in the trial.
p.000058: 6.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000058: 6.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of
...
p.000067:
p.000067: The PBSL reserves the right to interrupt and inspect any trial for which authorization has been given, as and when
p.000067: necessary for a good cause. An inspection of the conduct of a clinical trial by on-site visits forms part of PBSL’s
p.000067: monitoring activities.
p.000067: 8.1. Periodic Good Clinical Practice (GCP) Inspections of the trial sites shall be conducted to ensure that the
p.000067: facilities used continue to be acceptable throughout the clinical investigation.
p.000067: 8.2. The inspections may be carried out randomly, and/or for specific reasons and shall be either announced or
p.000067: unannounced.
p.000067: 8.3. An inspection would consist of a comparison of the procedures and practices of the principal investigator with the
p.000067: commitments set out in the protocol and reports submitted to PBSL by the investigator or the sponsor.
p.000067: 8.4. During the inspection PBSL shall assure itself that:
p.000067: 8.4.1. The facilities used by the investigator continue to be acceptable for the purposes of the study.
p.000067: 8.4.2. The approved study protocol for the investigation is being followed.
p.000067: 8.4.3. Any changes to the protocol have been approved by respective Ethics Committees and the Board
p.000067: 8.4.4. Accurate, complete and current records are being maintained.
p.000067: 8.4.5. Serious adverse events (SAEs) are reported to the sponsor and to the PBSL and institutional review board(s)
p.000067: within the stipulated time as specified in these guidelines.
p.000067: 8.4.6. The investigator is carrying out the agreed-upon activities, and has not delegated them to other previously
p.000067: unspecified staff.
p.000067: 8.5. During an inspection, inspectors:
p.000067: 8.5.1. Should be given easy access to the trial sites and laboratories at all times
p.000067: 8.5.2. Should have easy access to all patient files and raw data utilised for and generated during the trial. All site
p.000067: data and documents including participant files must be available for verification.
p.000067: 8.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that the
p.000067: conclusions that would be presented are derived correctly from the raw data.
p.000067: 8.7. Before an inspection, the principal investigator (or the co-investigator) shall be
p.000067:
p.000068: 68
p.000068:
p.000068: informed of the impending inspection either in writing, by phone or electronically.
p.000068:
p.000068: 8.8. An unannounced inspection may however be conducted, if the PBSL has reasonable cause to believe that the approved
p.000068: protocol is being violated.
p.000068: 9.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
p.000068: 9.1 Introduction
p.000068: Essential Documents are those documents which individually and collectively permit evaluation of the conduct
p.000068: of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the
p.000068: investigator, sponsor and monitor with the standards of Good Clinical Practice and with all PBSL regulatory
p.000068: requirements.
p.000068: Essential Documents also serve a number of other important purposes. Filing essential documents at the
p.000068: investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a
p.000068: trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the
p.000068: sponsor's independent audit function and inspected by the PBSL as part of the process to confirm the validity of the
p.000068: trial conduct and the integrity of data collected.
...
p.000075: X X
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: X X
p.000075: (where required)
p.000075:
p.000075: 28. DOCUMENTATION OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT
p.000075: (see 15.) X X
p.000075:
p.000075:
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076:
p.000076: NO. Title of Document Purpose
p.000076: Located in File
p.000076:
p.000076: Investigator/ Institution
p.000076: Sponsor
p.000076:
p.000076: 29. CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS
p.000076: (see .16) X
p.000076:
p.000076:
p.000076: 30. MONITORING VISIT REPORTS
p.000076: To document site visits by, and X findings of, the monitor
p.000076:
p.000076:
p.000076:
p.000076: 31. RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS
p.000076: - letters
p.000076: - meeting notes
p.000076: notes of telephone calls
p.000076: 32. SIGNED INFORMED CONSENT FORMS
p.000076: To document any agreements or X X significant discussions regarding
p.000076: trial administration, protocol violations, trial conduct, adverse event (AE) reporting
p.000076:
p.000076:
p.000076: To document that consent is X obtained in accordance with GCP
p.000076: and protocol and dated prior to participation of each subject in trial. Also to document direct access permission
p.000076: (see.3)
p.000076:
p.000076: 33. SOURCE DOCUMENTS To document the existence of the X
p.000076: subject and substantiate integrity of trial data collected. To include original documents related to the trial, to
p.000076: medical treatment, and history of subject
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077:
p.000077: NO. Title of Document Purpose
p.000077: Located in File
p.000077:
p.000077:
p.000077:
p.000077:
p.000077: 34. SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)
p.000077:
p.000077: 35. DOCUMENTATION OF CRF CORRECTIONS
p.000077:
p.000077:
p.000077:
p.000077: To document that the investigator or authorised member of the
p.000077: investigator’s staff confirms the observations recorded
p.000077:
p.000077: To document all changes/additions or corrections made to CRF after initial data were recorded
p.000077: Investigator/ Institution
p.000077: X
p.000077: (copy)
p.000077:
p.000077:
p.000077: X
p.000077: (copy)
p.000077: Sponsor
p.000077:
p.000077:
p.000077: X
p.000077: (original)
p.000077:
p.000077:
p.000077: X
p.000077: (original)
p.000077:
p.000077:
p.000077: 36. NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
p.000077: Notification by originating X X investigator to sponsor of serious
p.000077: adverse events and related reports in accordance with 4.11of this Guideline for GCP and 3.4 of PBSL Guideline for
p.000077: Conducting Clinical Trials.
p.000077:
p.000077:
p.000077: 37. NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO PBSL AND IRB(S)/IEC(S) OF UNEXPECTED
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Social / Age
Searching for indicator age:
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p.000002: In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic
p.000002: dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should
p.000002: be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship
p.000002: between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be
p.000002: ruled out.
p.000002: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which
p.000002: occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
p.000002: physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
p.000002: Expedited Reporting).
p.000002: Adverse Event (AE)
p.000002: Any untoward medical occurrence in a patient or clinical investigation subject administered a
p.000002: pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An
p.000002: adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory
p.000002: finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether
p.000002: or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data
p.000002: Management: Definitions and Standards for Expedited Reporting).
p.000002: Adult
p.000002: A person who is eighteen (18) years of age or over that age.
p.000002: Amendment (to the protocol)
p.000002: See Protocol Amendment.
p.000002: Applicable Regulatory Requirement(s)
p.000002: Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
p.000002: Approval(s)
p.000002: The affirmative decision of PBSL or the national ethics committee that the clinical trial has been reviewed and may be
p.000002: conducted at the institution site within the constraints set forth by the PBSL or the national ethics committee,
p.000002: the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000002: Audit
p.000002: A systematic and independent examination of trial related activities and documents to determine whether the
p.000002: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported
p.000002: according to the protocol, sponsor's standard
p.000002:
p.000003: 3
p.000003:
p.000003: operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
p.000003: Audit Certificate
p.000003: A declaration of confirmation by the auditor that an audit has taken place.
p.000003: Audit Report
p.000003: A written evaluation by the sponsor's auditor of the results of the audit.
p.000003:
p.000003: Audit Trail
p.000003: Documentation that allows reconstruction of the course of events.
p.000003: Blinding/Masking
p.000003: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000003: Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
p.000003: Phase I refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
...
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000022: performance of routine medical or psychological examinations or tests – referred to as 'negligible risk' in some
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
...
p.000062: (c) Toxicology
p.000062: A summary of the toxicological effects found in relevant studies conducted in different animal species should be
p.000062: described under the following headings where appropriate:
p.000062: − Single dose
p.000062:
p.000062: − Repeated dose
p.000062:
p.000062: − Carcinogenicity
p.000062:
p.000062: − Special studies (e.g. irritancy and sensitisation)
p.000062:
p.000062: − Reproductive toxicity
p.000062:
p.000062: − Genotoxicity (mutagenicity)
p.000062:
p.000062:
p.000062: 7.3.6 Effects in Humans Introduction:
p.000062: A thorough discussion of the known effects of the investigational product(s) in
p.000062: humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics,
p.000062: dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each
p.000062: completed clinical trial should be provided. Information should also be provided regarding results of any use of the
p.000062: investigational product(s) other than from in clinical trials, such as from experience during marketing.
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
p.000063: − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
p.000063:
p.000063:
p.000063: (b) Safety and Efficacy
p.000063: A summary of information should be provided about the investigational product's/products' (including
p.000063: metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were
p.000063: obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of
p.000063: this information should be discussed. In cases where a number of clinical trials have been completed, the use
p.000063: of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear
p.000063: presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those
p.000063: for all the studied indications) would be useful. Important differences in adverse drug reaction
p.000063: patterns/incidences across indications or subgroups should be discussed.
p.000063: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on
p.000063: the basis of prior experiences with the product under investigation and with related products. A description
p.000063: should also be provided of the precautions or special monitoring to be done as part of the
...
Social / Child
Searching for indicator child:
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p.000002: according to the protocol, sponsor's standard
p.000002:
p.000003: 3
p.000003:
p.000003: operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
p.000003: Audit Certificate
p.000003: A declaration of confirmation by the auditor that an audit has taken place.
p.000003: Audit Report
p.000003: A written evaluation by the sponsor's auditor of the results of the audit.
p.000003:
p.000003: Audit Trail
p.000003: Documentation that allows reconstruction of the course of events.
p.000003: Blinding/Masking
p.000003: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000003: Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
p.000003: Phase I refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
...
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
p.000022: minor increase over minimal risk. The intervention or procedure should present experiences to participants that are
p.000022: reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or
p.000022: education settings.
p.000022: • In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as
p.000022: participants.
p.000022:
p.000022: 3.4.1.1 Consent Requirements: For research with minors, the following should be obtained:
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
p.000023: women's health. Research ethics committees should consider whether the exclusion of women is justified in terms of
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
...
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
...
p.000082: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000082: his or her consent to participation at any time. The physician should then obtain the subject's freely-given
p.000082:
p.000083: 83
p.000083:
p.000083: informed consent, preferably in writing.
p.000083:
p.000083: 10. When obtaining informed consent for the research project the physician should be particularly cautious
p.000083: if the subject is in a dependent relationship to him or her or mayconsent under duress. In that case
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
p.000083: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
...
Searching for indicator children:
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p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000004: Phase IV trials are conducted after the national drug registration authority has approved a drug for distribution or
p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
...
p.000021: and/or advise.
p.000021: 3.3 RECORDS
p.000021: The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of
p.000021: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000022: performance of routine medical or psychological examinations or tests – referred to as 'negligible risk' in some
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
...
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000004: Phase IV trials are conducted after the national drug registration authority has approved a drug for distribution or
p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000034: and personally dated the informed consent form, the witness should sign and personally date the consent form. By
p.000034: signing the consent form, the witness attests that the information in the consent form and any other written
p.000034: information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable
p.000034: representative, and that informed consent was freely given by the subject or the subject’s legally
p.000034: acceptable representative.
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: 4.8.10 Both the informed consent discussion and the written informed consent form and any other written
p.000035: information to be provided to subjects should include explanations of the following:
p.000035: (a) That the trial involves research.
p.000035: (b) The purpose of the trial.
p.000035: (c) The trial treatment(s) and the probability for random assignment to each treatment.
p.000035: (d) The trial procedures to be followed, including all invasive procedures.
p.000035: (e) The subject's responsibilities.
p.000035: (f) Those aspects of the trial that are experimental.
p.000035: (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
p.000035: nursing infant.
p.000035: (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
p.000035: made aware of this.
p.000035: (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
p.000035: potential benefits and risks.
p.000035: (j) The compensation and/or treatment available to the subject in the event of trial-related injury.
p.000035: (k) The anticipated prorated payment, if any, to the subject for participating in the trial.
p.000035: (l) The anticipated expenses, if any, to the subject for participating in the trial.
p.000035: (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
p.000035: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.000035: (n) That the monitor(s), the auditor(s), the IRB/IEC, and PBSL will be granted direct access to the
p.000035: subject's original medical records for verification of clinical trial procedures and/or data, without violating the
p.000035: confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
p.000035: signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing
p.000035: such access.
p.000035: (o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
p.000035: and/or regulations, will not be made publicly available. If the results of the trial are published, the
...
Searching for indicator foetus:
(return to top)
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
p.000023: women's health. Research ethics committees should consider whether the exclusion of women is justified in terms of
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
p.000023: perpetuate discriminations against women by unfairly or unjustifiably excluding them from study protocols.
p.000023: 3.4.2.1 Women and Pregnancy: Research ethics committees must give extra attention to research that involves
p.000023: women who are, or may become pregnant, because of the additional health concerns during pregnancy and the need to avoid
p.000023: unnecessary risk to the foetus. Reasons for excluding women from research should be adequately justified both from
p.000023: the point of protecting the health of a foetus and from the perspective of whether such exclusion is
p.000023: scientifically supportable.
p.000023: No research activities involving pregnant women and foetuses may be undertaken unless:
p.000023: • Appropriate studies on animals and non-pregnant individuals have been completed;
p.000023: • The purpose of the activity is to meet the health needs of the mother of the particular foetus, the risk to the
p.000023: foetus is minimal and, in all cases, presents the least possible risk for achieving the objectives of the activity.
p.000023: • Individuals engaged in the activity will have no part in 1) any decision as to the timing, method and
p.000023: procedures used to terminate the pregnancy, and 2) determining the viability of the foetus at the termination of
p.000023: the pregnancy; and
p.000023: • No procedural changes which may cause greater than minimal risk to the foetus or the pregnant woman will be
p.000023: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000023: The father's informed consent need not be secured if:
p.000023: • the purpose of the activity is to meet the health needs of the mother;
p.000023: • his identity or whereabouts cannot reasonably be ascertained;
p.000023: • he is not reasonably available; or
p.000023: • the pregnancy results from rape.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 3.4.2.2 Foetuses In-Utero as Participants: No foetus in utero may be involved as a participant in any research activity
p.000024: unless:
p.000024: • the purpose of the activity is to meet the health needs of the particular foetus and the foetus will be placed at
p.000024: risk only to the minimum extent necessary to meet such needs; or
p.000024: • the risk to the foetus imposed by the research is minimal and the purpose of the activity is the development of
p.000024: important biomedical knowledge which cannot be obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and have
p.000024: given their informed consent.
p.000024: The father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024: 3.4.2.3 Foetuses Ex Utero, including Nonviable Foetuses, as Participants:Until it has been ascertained whether or not a
p.000024: foetus ex utero is viable, a foetus ex utero may not be involved as a participant in any research activity unless:
p.000024: • there will be no added risk to the foetus resulting from the activity, and the purpose of the activity is the
p.000024: development of important biomedical knowledge which cannot be obtained by other means, or
p.000024: • the purpose of the activity is to enhance the possibility of survival of the particular foetus to the
p.000024: point of viability.
p.000024: No nonviable foetus may be involved as a participant in any research activity unless:
p.000024: • vital functions of the foetus will not be artificially maintained; experimental activities which of themselves
p.000024: would terminate the heartbeat or respiration of the foetus will not be employed; and
p.000024: • the purpose of the activity is the development of important biomedical knowledge which cannot be
p.000024: obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and
p.000024: have given their informed consent, except that the father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Individuals engaged in the activity will have no part in (1) any decision as to the timing, method
p.000025: and procedures used to terminate the pregnancy, and/or (2) determining the viability of the foetus at
p.000025: the termination of the pregnancy.
p.000025: No procedural changes, which may cause greater than minimal risk to the foetus or the pregnant woman, will be
p.000025: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
...
Searching for indicator foetuses:
(return to top)
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
p.000023: perpetuate discriminations against women by unfairly or unjustifiably excluding them from study protocols.
p.000023: 3.4.2.1 Women and Pregnancy: Research ethics committees must give extra attention to research that involves
p.000023: women who are, or may become pregnant, because of the additional health concerns during pregnancy and the need to avoid
p.000023: unnecessary risk to the foetus. Reasons for excluding women from research should be adequately justified both from
p.000023: the point of protecting the health of a foetus and from the perspective of whether such exclusion is
p.000023: scientifically supportable.
p.000023: No research activities involving pregnant women and foetuses may be undertaken unless:
p.000023: • Appropriate studies on animals and non-pregnant individuals have been completed;
p.000023: • The purpose of the activity is to meet the health needs of the mother of the particular foetus, the risk to the
p.000023: foetus is minimal and, in all cases, presents the least possible risk for achieving the objectives of the activity.
p.000023: • Individuals engaged in the activity will have no part in 1) any decision as to the timing, method and
p.000023: procedures used to terminate the pregnancy, and 2) determining the viability of the foetus at the termination of
p.000023: the pregnancy; and
p.000023: • No procedural changes which may cause greater than minimal risk to the foetus or the pregnant woman will be
p.000023: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000023: The father's informed consent need not be secured if:
p.000023: • the purpose of the activity is to meet the health needs of the mother;
p.000023: • his identity or whereabouts cannot reasonably be ascertained;
p.000023: • he is not reasonably available; or
p.000023: • the pregnancy results from rape.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: 3.4.2.2 Foetuses In-Utero as Participants: No foetus in utero may be involved as a participant in any research activity
p.000024: unless:
p.000024: • the purpose of the activity is to meet the health needs of the particular foetus and the foetus will be placed at
p.000024: risk only to the minimum extent necessary to meet such needs; or
p.000024: • the risk to the foetus imposed by the research is minimal and the purpose of the activity is the development of
p.000024: important biomedical knowledge which cannot be obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and have
p.000024: given their informed consent.
p.000024: The father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024: 3.4.2.3 Foetuses Ex Utero, including Nonviable Foetuses, as Participants:Until it has been ascertained whether or not a
p.000024: foetus ex utero is viable, a foetus ex utero may not be involved as a participant in any research activity unless:
p.000024: • there will be no added risk to the foetus resulting from the activity, and the purpose of the activity is the
p.000024: development of important biomedical knowledge which cannot be obtained by other means, or
p.000024: • the purpose of the activity is to enhance the possibility of survival of the particular foetus to the
p.000024: point of viability.
p.000024: No nonviable foetus may be involved as a participant in any research activity unless:
p.000024: • vital functions of the foetus will not be artificially maintained; experimental activities which of themselves
p.000024: would terminate the heartbeat or respiration of the foetus will not be employed; and
p.000024: • the purpose of the activity is the development of important biomedical knowledge which cannot be
p.000024: obtained by other means.
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
p.000011: practice.
...
Social / Incarcerated
Searching for indicator incarcerated:
(return to top)
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
...
Searching for indicator liberty:
(return to top)
p.000082: 4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the
p.000082: objective is in proportion to the inherent risk to the subject.
p.000082: 5. Every biomedical research project involving human subjects should be preceded by careful assessment of
p.000082: predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the
p.000082: interests of the subject must always prevail over the interests of science and society.
p.000082: 6. The right of the research subject to safeguard his or her integrity must always be respected. Every
p.000082: precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the
p.000082: subject's physical and mental integrity and on the personality of the subject.
p.000082: 7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that
p.000082: the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found
p.000082: to outweigh the potential benefits.
p.000082: 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000082: results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be
p.000082: accepted for publication.
p.000082: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000082: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000082: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000082: his or her consent to participation at any time. The physician should then obtain the subject's freely-given
p.000082:
p.000083: 83
p.000083:
p.000083: informed consent, preferably in writing.
p.000083:
p.000083: 10. When obtaining informed consent for the research project the physician should be particularly cautious
p.000083: if the subject is in a dependent relationship to him or her or mayconsent under duress. In that case
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
...
Searching for indicator prison:
(return to top)
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: • research on practices, both innovative and accepted, that have the intent and probability of improving
p.000027: the health or wellbeing of prisoners.
p.000027: Where some prisoners may be assigned to control groups that may not benefit from the research, the research may
p.000027: proceed only after appropriate experts have been consulted. Research that could be conducted on a
p.000027: population other than prisoners should not be permitted, unless cogent motivation is presented to the research
p.000027: ethics committee, and the committee is satisfied that the motivation does not represent exploitative
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
p.000027: • A majority of the research ethics committee, other than prison members, shall have no association with the
p.000027: prison(s) involved, apart from their membership of the research ethics committee;
p.000027: • At least one member of the research ethics committee shall be a prisoner, or a prisoners'
p.000027: representative with appropriate background and experience to serve in that capacity. Where a research project is
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
p.000027:
p.000028: 28
p.000028:
p.000028: interests. The collection of even small blood samples additional to those required for diagnostic purposes, or the
p.000028: handling of a low birth-weight infant to make observations will demand careful scrutiny.
p.000028: 3.4.6.3 Terminal Care Research: Research in terminal care is distinguished by the short remaining life expectancy
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
...
p.000034: and personally dated the informed consent form, the witness should sign and personally date the consent form. By
p.000034: signing the consent form, the witness attests that the information in the consent form and any other written
p.000034: information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable
p.000034: representative, and that informed consent was freely given by the subject or the subject’s legally
p.000034: acceptable representative.
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: 4.8.10 Both the informed consent discussion and the written informed consent form and any other written
p.000035: information to be provided to subjects should include explanations of the following:
p.000035: (a) That the trial involves research.
p.000035: (b) The purpose of the trial.
p.000035: (c) The trial treatment(s) and the probability for random assignment to each treatment.
p.000035: (d) The trial procedures to be followed, including all invasive procedures.
p.000035: (e) The subject's responsibilities.
p.000035: (f) Those aspects of the trial that are experimental.
p.000035: (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
p.000035: nursing infant.
p.000035: (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
p.000035: made aware of this.
p.000035: (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
p.000035: potential benefits and risks.
p.000035: (j) The compensation and/or treatment available to the subject in the event of trial-related injury.
p.000035: (k) The anticipated prorated payment, if any, to the subject for participating in the trial.
p.000035: (l) The anticipated expenses, if any, to the subject for participating in the trial.
p.000035: (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
p.000035: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.000035: (n) That the monitor(s), the auditor(s), the IRB/IEC, and PBSL will be granted direct access to the
p.000035: subject's original medical records for verification of clinical trial procedures and/or data, without violating the
p.000035: confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
p.000035: signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing
p.000035: such access.
p.000035: (o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
p.000035: and/or regulations, will not be made publicly available. If the results of the trial are published, the
p.000035: subject’s identity will remain confidential.
p.000035:
p.000035:
p.000036: 36
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000015: ethical review SLERSC.
p.000015:
p.000016: 16
p.000016:
p.000016: • Data and Safety Monitoring Committees: These committees oversee ongoing clinical trials with respect to treatment,
p.000016: efficacy and safety. In the advent of clear evidence of efficacy or harm, prior to the end of the trial, premature
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
p.000016: appropriate for the local setting and that particular modifications are made to the local study when required e.g.
p.000016: inclusion/exclusion criteria. Special attention should also be paid to the sampling strategy when reviewing
p.000016: multi- centred clinical trials.
p.000016: Furthermore, it is unacceptable for developed country participants to have better standards of care offered
p.000016: in the study when compared to Sierra Leone participants. When Sierra Leone is chosen for a clinical trial while the
p.000016: trial is not undertaken in the
p.000016:
p.000017: 17
p.000017:
p.000017: country of origin an explanation should be sought about why this is the case.
p.000017:
p.000017: 1.3 SCOPE OF THIS GUIDELINE
p.000017:
...
p.000033: that have their origin in the Declaration of Helsinki(see Appendix 3 of this Guideline). Prior to the beginning
p.000033: of the trial, the investigator should have the IRB/IEC's written approval/favourable opinion of the written informed
p.000033: consent form and any other written information to be provided to subjects.
p.000033: 4.8.2 The written informed consent form and any other written information to be provided to subjects should be
p.000033: revised whenever important new information becomes available that may be relevant to the subject’s
p.000033: consent. Any revised written informed consent form, and written information should receive PBSL approval in advance
p.000033: of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner
p.000033: if new information becomes available that may be relevant to the subject’s willingness to continue participation in the
p.000033: trial. The communication of this information should be documented.
p.000033: 4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a
p.000033:
p.000034: 34
p.000034:
p.000034: subject to participate or to continue to participate in a trial.
p.000034: 4.8.4 None of the oral and written information concerning the trial, including the written informed consent form,
p.000034: should contain any language that causes the subject or the subject's legally acceptable representative to waive or to
p.000034: appear to waive any legal rights, or that releases or appears to release the investigator, the institution,
p.000034: the sponsor, or their agents from liability for negligence.
p.000034: 4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject
p.000034: is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the
p.000034: trial including the written information and the approval by PBSL.
p.000034: 4.8.6 The language used in the oral and written information about the trial, including the written informed consent
p.000034: form, should be as non-technical as practical and should be understandable to the subject or the subject's legally
p.000034: acceptable representative and the impartial witness, where applicable.
p.000034: 4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator, should
p.000034: provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire
p.000034: about details of the trial and to decide whether or not to participate in the trial. All questions about the trial
p.000034: should be answered to the satisfaction of the subject or the subject's legally acceptable representative.
p.000034: 4.8.8 Prior to a subject’s participation in the trial, the written informed consent form should be signed and
p.000034: personally dated by the subject or by the subject's legally acceptable representative, and by the person who conducted
p.000034: the informed consent discussion.
p.000034: 4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial
p.000034: witness should be present during the entire informed consent discussion. After the written informed consent
p.000034: form and any other written information to be provided to subjects, is read and explained to the subject or the
p.000034: subject’s legally acceptable representative, and after the subject or the subject’s legally acceptable
...
Social / Literacy
Searching for indicator literacy:
(return to top)
p.000015: Sanitation on health research ethics in Sierra Leone. All clinical trials conducted in Sierra Leone must undergo
p.000015: ethical review SLERSC.
p.000015:
p.000016: 16
p.000016:
p.000016: • Data and Safety Monitoring Committees: These committees oversee ongoing clinical trials with respect to treatment,
p.000016: efficacy and safety. In the advent of clear evidence of efficacy or harm, prior to the end of the trial, premature
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000002: A person who is eighteen (18) years of age or over that age.
p.000002: Amendment (to the protocol)
p.000002: See Protocol Amendment.
p.000002: Applicable Regulatory Requirement(s)
p.000002: Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
p.000002: Approval(s)
p.000002: The affirmative decision of PBSL or the national ethics committee that the clinical trial has been reviewed and may be
p.000002: conducted at the institution site within the constraints set forth by the PBSL or the national ethics committee,
p.000002: the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000002: Audit
p.000002: A systematic and independent examination of trial related activities and documents to determine whether the
p.000002: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported
p.000002: according to the protocol, sponsor's standard
p.000002:
p.000003: 3
p.000003:
p.000003: operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
p.000003: Audit Certificate
p.000003: A declaration of confirmation by the auditor that an audit has taken place.
p.000003: Audit Report
p.000003: A written evaluation by the sponsor's auditor of the results of the audit.
p.000003:
p.000003: Audit Trail
p.000003: Documentation that allows reconstruction of the course of events.
p.000003: Blinding/Masking
p.000003: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000003: Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
...
p.000004: Phase IV trials are conducted after the national drug registration authority has approved a drug for distribution or
p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
...
p.000007: requirements".
p.000007: Investigator's Brochure
p.000007: A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study
p.000007: of the investigational product(s) in human subjects (see section7. Investigator’s Brochure).
p.000007: Legally Acceptable Representative
p.000007: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective
p.000007: subject, to the subject's participation in the clinical trial.
p.000007:
p.000007:
p.000007: Local Monitor A person appointed by the Sponsor or CRO to oversee the progress of a clinical trial and of ensuring that
p.000007: it is conducted, recorded and reported in accordance with the SOPs, GCP and the applicable regulatory requirements.
p.000007:
p.000007:
p.000007: Monitoring
p.000007: The act of overseeing the progress of a clinical trial either by PBSL or an independent monitor selected by the sponsor
p.000007: to ensure that it is conducted, recorded, and reported in
p.000007:
p.000008: 8
p.000008:
p.000008: accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
p.000008: applicable regulatory requirement(s).
p.000008:
p.000008:
p.000008: Monitoring Report
p.000008: A written report from the monitor to the sponsor after each site visit and/or other trial-related
p.000008: communication according to the sponsor’s SOPs.
p.000008: Monitoring Plan
p.000008: A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial.
p.000008: Multicentre Trial
p.000008: A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more
p.000008: than one investigator.
p.000008: Nonclinical Study
p.000008: Biomedical studies not performed on human subjects.
p.000008: Opinion (in relation to Independent Ethics Committee)
p.000008: The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
p.000008: Original Medical Record
p.000008: See Source Documents.
p.000008: PBSL means Pharmacy Board of Sierra Leone
p.000008: Placebo A medication with no active ingredients or a procedure without any medical benefit.
p.000008: Principal Investigator / Investigator The person responsible for the conduct of the clinical trial at the clinical
p.000008: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000008: located.
p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
...
p.000061: observed effects, the relevance to humans, and any aspects to be studied in humans. If applicable, the
p.000061: effective and nontoxic dose findings in the same animal species should be compared (i.e., the therapeutic index
p.000061: should be discussed). The relevance of this information to the proposed human dosing should be addressed.
p.000061: Whenever possible, comparisons should be made in terms of blood/tissue levels rather than on a mg/kg basis.
p.000061: (a) Nonclinical Pharmacology
p.000061: A summary of the pharmacological aspects of the investigational product and, where appropriate, its significant
p.000061: metabolites studied in animals, should be included. Such a summary should incorporate studies that assess
p.000061: potential therapeutic activity (e.g. efficacy models, receptor binding, and specificity) as well as those that assess
p.000061: safety (e.g., special studies to assess pharmacological actions other than the intended therapeutic effect(s).
p.000061: (b) Pharmacokinetics and Product Metabolism in Animals
p.000061: A summary of the pharmacokinetics and biological transformation and disposition of the investigational
p.000061: product in all species studied should be given.
p.000061:
p.000061:
p.000062: 62
p.000062:
p.000062: The discussion of the findings should address the absorption and the local and systemic bioavailability of the
p.000062: investigational product and its metabolites, and their relationship to the pharmacological and toxicological findings
p.000062: in animal species.
p.000062: (c) Toxicology
p.000062: A summary of the toxicological effects found in relevant studies conducted in different animal species should be
p.000062: described under the following headings where appropriate:
p.000062: − Single dose
p.000062:
p.000062: − Repeated dose
p.000062:
p.000062: − Carcinogenicity
p.000062:
p.000062: − Special studies (e.g. irritancy and sensitisation)
p.000062:
p.000062: − Reproductive toxicity
p.000062:
p.000062: − Genotoxicity (mutagenicity)
p.000062:
p.000062:
p.000062: 7.3.6 Effects in Humans Introduction:
p.000062: A thorough discussion of the known effects of the investigational product(s) in
p.000062: humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics,
p.000062: dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each
p.000062: completed clinical trial should be provided. Information should also be provided regarding results of any use of the
p.000062: investigational product(s) other than from in clinical trials, such as from experience during marketing.
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
...
Social / Presence of Coercion
Searching for indicator coerce:
(return to top)
p.000033: adverse event) of the investigational product(s).
p.000033: 4.8 Informed Consent of Trial Subjects
p.000033: 4.8.1 In obtaining and documenting informed consent, the investigator should comply with the applicable
p.000033: regulatory requirement(s) such as PBSL requirements and should adhere to GCP and to the ethical principles
p.000033: that have their origin in the Declaration of Helsinki(see Appendix 3 of this Guideline). Prior to the beginning
p.000033: of the trial, the investigator should have the IRB/IEC's written approval/favourable opinion of the written informed
p.000033: consent form and any other written information to be provided to subjects.
p.000033: 4.8.2 The written informed consent form and any other written information to be provided to subjects should be
p.000033: revised whenever important new information becomes available that may be relevant to the subject’s
p.000033: consent. Any revised written informed consent form, and written information should receive PBSL approval in advance
p.000033: of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner
p.000033: if new information becomes available that may be relevant to the subject’s willingness to continue participation in the
p.000033: trial. The communication of this information should be documented.
p.000033: 4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a
p.000033:
p.000034: 34
p.000034:
p.000034: subject to participate or to continue to participate in a trial.
p.000034: 4.8.4 None of the oral and written information concerning the trial, including the written informed consent form,
p.000034: should contain any language that causes the subject or the subject's legally acceptable representative to waive or to
p.000034: appear to waive any legal rights, or that releases or appears to release the investigator, the institution,
p.000034: the sponsor, or their agents from liability for negligence.
p.000034: 4.8.5 The investigator, or a person designated by the investigator, should fully inform the subject or, if the subject
p.000034: is unable to provide informed consent, the subject's legally acceptable representative, of all pertinent aspects of the
p.000034: trial including the written information and the approval by PBSL.
p.000034: 4.8.6 The language used in the oral and written information about the trial, including the written informed consent
p.000034: form, should be as non-technical as practical and should be understandable to the subject or the subject's legally
p.000034: acceptable representative and the impartial witness, where applicable.
p.000034: 4.8.7 Before informed consent may be obtained, the investigator, or a person designated by the investigator, should
p.000034: provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
p.000011: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Sierra Leone are
p.000011: designed and conducted according to sound scientific and ethical standards within the framework of good clinical
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
p.000029: Research ethics committee must therefore take great care when assessing emergency care research.
p.000029: Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to
p.000029: obtain consent for inclusion without delaying the initiation of treatment, and so risking a reduction of
p.000029: potential benefits. As such there may be circumstances in which it is not possible to obtain consent for
p.000029: inclusion in emergency care research. After a protocol has been presented by a researcher giving clear reasons to
p.000029: justify the initiation of the emergency care research without consent, a research ethics committee may approve the
p.000029: research without consent provided it is satisfied that:
p.000029: • reasonable steps are being taken to ascertain the religious and cultural sensitivities of patients experiencing
p.000029: medical emergencies;
p.000029: • the condition of the patient precludes the giving of consent;
p.000029: • inclusion in the trial is not contrary to the interests of the patient;
p.000029: • the research is intended to be therapeutic and poses no more risk than is inherent to the patient's condition or
p.000029: would be caused by alternative methods of treatment;
p.000029: • the patient and the patient's next of kin or legal representatives will be informed as soon as is reasonably
p.000029: possible of the patient's inclusion in the study and of the option to withdraw from the research project at any time;
p.000029: • the patient will be informed, and consent obtained, once the patient who has undergone the necessary
p.000029: emergency procedures has regained consciousness; and
p.000029: • the research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard
p.000029: care.
p.000029:
p.000029:
p.000029:
p.000029: 4. INVESTIGATOR
p.000029: 4.1 Investigator's Qualifications and Agreements
p.000029: 4.1.1 The investigator(s) should be qualified by education, training, and experience to
p.000029:
p.000030: 30
p.000030:
p.000030: assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications and
p.000030: experience through an up to date Curriculum Vitae. The Principal investigator’s qualification should be in
...
Social / Soldier
Searching for indicator armed forces:
(return to top)
p.000010: Investigator's Brochure for an unapproved investigational product or package insert/summary of product
p.000010: characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and
p.000010: Standards for Expedited Reporting).
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
...
Social / Unemployment
Searching for indicator unemployed:
(return to top)
p.000010: Standards for Expedited Reporting).
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000021: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
...
p.000024: obtained by other means.
p.000024: Any activity permitted above may be conducted only if the mother and father are legally competent and
p.000024: have given their informed consent, except that the father's informed consent need not be secured if:
p.000024: • his identity or whereabouts cannot reasonably be ascertained;
p.000024: • he is not reasonably available; or
p.000024: • the pregnancy resulted from rape.
p.000024:
p.000024:
p.000024:
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: Individuals engaged in the activity will have no part in (1) any decision as to the timing, method
p.000025: and procedures used to terminate the pregnancy, and/or (2) determining the viability of the foetus at
p.000025: the termination of the pregnancy.
p.000025: No procedural changes, which may cause greater than minimal risk to the foetus or the pregnant woman, will be
p.000025: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000025: Any activity permitted above may be conducted only if the mother is legally competent and has given
p.000025: informed consent after having been fully informed about the possible impact on the foetus.
p.000025:
p.000025: 3.4.3 People with Mental Disabilities or Substance Abuse Related Disorders: People with mental disabilities include
p.000025: those people with psychiatric, cognitive or developmental disorders. The issue with these groups of people as far as
p.000025: research is concerned, is their capacity for reason regarding participation and comprehension of information provided.
p.000025: This issue is also applicable to research on persons with substance abuse related disorders. Institutionalisation may
p.000025: also further compromise a person's ability to make a truly voluntary decision to participate in a study.
p.000025: Research in people with mental disabilities or with substance abuse related disorders must therefore:
p.000025: • Be relevant to mental disabilities or substance abuse related disorders so that it is necessary to involve people
p.000025: who have a mental disability and/or a substance abuse related disorder/s;
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
...
Social / Women
Searching for indicator women:
(return to top)
p.000021: and/or advise.
p.000021: 3.3 RECORDS
p.000021: The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of
p.000021: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
...
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
p.000023: women's health. Research ethics committees should consider whether the exclusion of women is justified in terms of
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
p.000023: perpetuate discriminations against women by unfairly or unjustifiably excluding them from study protocols.
p.000023: 3.4.2.1 Women and Pregnancy: Research ethics committees must give extra attention to research that involves
p.000023: women who are, or may become pregnant, because of the additional health concerns during pregnancy and the need to avoid
p.000023: unnecessary risk to the foetus. Reasons for excluding women from research should be adequately justified both from
p.000023: the point of protecting the health of a foetus and from the perspective of whether such exclusion is
p.000023: scientifically supportable.
p.000023: No research activities involving pregnant women and foetuses may be undertaken unless:
p.000023: • Appropriate studies on animals and non-pregnant individuals have been completed;
p.000023: • The purpose of the activity is to meet the health needs of the mother of the particular foetus, the risk to the
p.000023: foetus is minimal and, in all cases, presents the least possible risk for achieving the objectives of the activity.
p.000023: • Individuals engaged in the activity will have no part in 1) any decision as to the timing, method and
p.000023: procedures used to terminate the pregnancy, and 2) determining the viability of the foetus at the termination of
p.000023: the pregnancy; and
p.000023: • No procedural changes which may cause greater than minimal risk to the foetus or the pregnant woman will be
p.000023: introduced into the procedure for terminating the pregnancy solely in the interest of the activity.
p.000023: The father's informed consent need not be secured if:
p.000023: • the purpose of the activity is to meet the health needs of the mother;
p.000023: • his identity or whereabouts cannot reasonably be ascertained;
p.000023: • he is not reasonably available; or
p.000023: • the pregnancy results from rape.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000024: 24
p.000024:
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000002:
p.000003: 3
p.000003:
p.000003: operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
p.000003: Audit Certificate
p.000003: A declaration of confirmation by the auditor that an audit has taken place.
p.000003: Audit Report
p.000003: A written evaluation by the sponsor's auditor of the results of the audit.
p.000003:
p.000003: Audit Trail
p.000003: Documentation that allows reconstruction of the course of events.
p.000003: Blinding/Masking
p.000003: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000003: Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
p.000003: Phase I refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
...
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000022: performance of routine medical or psychological examinations or tests – referred to as 'negligible risk' in some
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
p.000022: minor increase over minimal risk. The intervention or procedure should present experiences to participants that are
p.000022: reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or
p.000022: education settings.
p.000022: • In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as
p.000022: participants.
p.000022:
p.000022: 3.4.1.1 Consent Requirements: For research with minors, the following should be obtained:
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
p.000023: women's health. Research ethics committees should consider whether the exclusion of women is justified in terms of
p.000023: research priorities and the specific research question under consideration. As part of advocating improved
p.000023: health for women, researchers have ethical obligations to conduct research that does not
p.000023: perpetuate discriminations against women by unfairly or unjustifiably excluding them from study protocols.
p.000023: 3.4.2.1 Women and Pregnancy: Research ethics committees must give extra attention to research that involves
p.000023: women who are, or may become pregnant, because of the additional health concerns during pregnancy and the need to avoid
...
p.000082: accepted for publication.
p.000082: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000082: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000082: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000082: his or her consent to participation at any time. The physician should then obtain the subject's freely-given
p.000082:
p.000083: 83
p.000083:
p.000083: informed consent, preferably in writing.
p.000083:
p.000083: 10. When obtaining informed consent for the research project the physician should be particularly cautious
p.000083: if the subject is in a dependent relationship to him or her or mayconsent under duress. In that case
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
p.000083: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
p.000083: 6. The physician can combine medical research with professional care, the objective being the acquisition of new
p.000083: medical knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000083: therapeutic value for the patient.
p.000083: III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
p.000084: 84
p.000084:
...
Social / education
Searching for indicator education:
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p.000012: ethical guidelines for clinical trials.
p.000012: The principles of GCP include:
p.000012:
p.000012: 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
p.000012: Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
p.000012: 2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000012: benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated
p.000012: benefits justify the risks.
p.000012: 3) The rights, safety, and well-being of the trial subjects are the most important considerations and
p.000012: should prevail over interests of science and society.
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: 4) The available nonclinical and clinical information on an investigational product should be adequate to
p.000013: support the proposed clinical trial.
p.000013: 5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
p.000013: 6) A trial should be conducted in compliance with the protocol that has received prior institutional review
p.000013: board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
p.000013: 7) The medical care given to, and medical decisions made on behalf of, subjects should always be the
p.000013: responsibility of a qualified physician or, when appropriate, of a qualified dentist.
p.000013: 8) Each individual involved in conducting a trial should be qualified by education, training, and experience to
p.000013: perform his or her respective task(s).
p.000013: 9) Freely given informed consent should be obtained from every subject prior to clinical trial
p.000013: participation.
p.000013: 10) All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting,
p.000013: interpretation and verification.
p.000013: 11) The confidentiality of records that could identify subjects should be protected, respecting the privacy
p.000013: and confidentiality rules in accordance with the applicable regulatory requirement(s).
p.000013: 12) Investigational products should be manufactured, handled, and stored in accordance with applicable
p.000013: good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
p.000013: 13) Systems with procedures that assure the quality of every aspect of the trial should be implemented.
p.000013: The practical application of these principles requires research studies to have distinct components built
p.000013: into them. These include relevant and appropriate study rationale, optimal study design, investigator
p.000013: competence, a balance of risks and benefits for participants, transparency, patient privacy, ethical review
p.000013: and impartial oversight of consent procedures. To follow is a brief discussion on some of these issues as they
p.000013: relate to Sierra Leone.
p.000013: 1.2.1. Study Rationale and Motivation: A study rationale and motivation which does not ask relevant and important
p.000013: questions is unethical. The study rationale should demonstrate that the study question under consideration
p.000013: has not been substantially
p.000013:
p.000013:
...
p.000014: questions. Adequate supporting information and explanation on the study sample size and study population must be
p.000014: provided.
p.000014: The social context of a proposed research population that creates conditions for possible exploitation or
p.000014: increased vulnerability among potential research participants should be assessed, where this is relevant. Steps
p.000014: must be taken to overcome these conditions, and to promote and protect the dignity, safety and welfare of
p.000014: participants. The vulnerability factors and steps that will be taken to offset these should be addressed
p.000014: in the study design and clearly outlined in the research protocol. It is imperative that sound study
p.000014: designs, and use of universally accepted ethical standards are applied in both vulnerable and non-vulnerable
p.000014: communities.
p.000014: The design of the study should in no way prejudice the ongoing treatment and care of patients, nor should it in anyway
p.000014: undermine or confuse patients with respect to the best available local standard treatment practices and national policy
p.000014: approaches. If these are not ensured, then the design is unethical.
p.000014: 1.2.3 Investigator Competence: The Principal Investigator's (and other investigators') competence
p.000014: is assessed by two major parameters: technical and humanistic. Technical competence which includes research
p.000014: competence is assessed by education, knowledge, certification and experience such that the investigator is able to
p.000014: assume responsibility for the proper conduct of a trial, should meet all the qualifications
p.000014: specified by applicable regulatory requirement(s), and should provide evidence of such qualifications through an
p.000014: up-to-date curriculum vitae and/or other relevant documentation requested PBSL. Humanistic parameters require
p.000014: compassion and empathy. This is provided by a proper clinical and research environment, encompassing good
p.000014: research mentoring. In all cases the Principal Investigator for each
p.000014:
p.000015: 15
p.000015:
p.000015: site must be a Sierra Leonean-based scientist (domicile in Sierra Leone).
p.000015:
p.000015: 1.2.4 Balance of Harm and Benefit: A risk benefit analysis of the study should precede the conduct of the
p.000015: research itself. The risk-benefit analysis should take full cognisance of benefits and harms beyond the life of the
p.000015: study itself, particularly in the case of chronic life-threatening conditions. Alternative ways of providing benefits
p.000015: to the patients might be available without research; thus, the distinction between the probability of harm
p.000015: and the possible benefits of the effects must be made. The principal investigator has the ethical duty of
p.000015: excluding participants who are at undue risk.
p.000015: 1.2.5 Transparency: Clinical trialists have an ethical obligation to honestly report a trial's existence and findings.
...
p.000015: Sanitation on health research ethics in Sierra Leone. All clinical trials conducted in Sierra Leone must undergo
p.000015: ethical review SLERSC.
p.000015:
p.000016: 16
p.000016:
p.000016: • Data and Safety Monitoring Committees: These committees oversee ongoing clinical trials with respect to treatment,
p.000016: efficacy and safety. In the advent of clear evidence of efficacy or harm, prior to the end of the trial, premature
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
p.000016: appropriate for the local setting and that particular modifications are made to the local study when required e.g.
...
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
p.000022: not greater in and of themselves than those ordinarily encountered in daily life or during the
p.000022: performance of routine medical or psychological examinations or tests – referred to as 'negligible risk' in some
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
p.000022: minor increase over minimal risk. The intervention or procedure should present experiences to participants that are
p.000022: reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or
p.000022: education settings.
p.000022: • In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as
p.000022: participants.
p.000022:
p.000022: 3.4.1.1 Consent Requirements: For research with minors, the following should be obtained:
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
...
p.000029: research without consent provided it is satisfied that:
p.000029: • reasonable steps are being taken to ascertain the religious and cultural sensitivities of patients experiencing
p.000029: medical emergencies;
p.000029: • the condition of the patient precludes the giving of consent;
p.000029: • inclusion in the trial is not contrary to the interests of the patient;
p.000029: • the research is intended to be therapeutic and poses no more risk than is inherent to the patient's condition or
p.000029: would be caused by alternative methods of treatment;
p.000029: • the patient and the patient's next of kin or legal representatives will be informed as soon as is reasonably
p.000029: possible of the patient's inclusion in the study and of the option to withdraw from the research project at any time;
p.000029: • the patient will be informed, and consent obtained, once the patient who has undergone the necessary
p.000029: emergency procedures has regained consciousness; and
p.000029: • the research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard
p.000029: care.
p.000029:
p.000029:
p.000029:
p.000029: 4. INVESTIGATOR
p.000029: 4.1 Investigator's Qualifications and Agreements
p.000029: 4.1.1 The investigator(s) should be qualified by education, training, and experience to
p.000029:
p.000030: 30
p.000030:
p.000030: assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications and
p.000030: experience through an up to date Curriculum Vitae. The Principal investigator’s qualification should be in
p.000030: accordance with Section 3.2 sub-section 3.2.3 under the PBSL Guidelines for Conducting Clinical Trials.
p.000030: 4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational
p.000030: product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in
p.000030: other information sources provided by the sponsor.
p.000030: 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
p.000030: 4.1.4 The investigator should permit monitoring and auditing by PBSL.
p.000030: 4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated
p.000030: significant trial-related duties.
p.000030: 4.1.6 The Investigator should not have been found guilty of any misconduct under the Sierra Leone Medical
p.000030: and Dental Council.
p.000030: 4.1.7 The Principal Investigator must be an appropriately qualified and competent person having practical experience
p.000030: within the relevant professional area, who is resident in Sierra Leone and who is responsible for the conduct
p.000030: of the clinical trial at a clinical site. A Principal Investigator must have had previous experience as a
p.000030: co-investigator in at least two trials in the relevant professional area.
p.000030: 4.1.8. All investigators in a clinical trial as well as the trial monitor must have had formal training in Good
p.000030: Clinical Practice (GCP) within the last two years.
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Social / embryo
Searching for indicator embryo:
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p.000034: representative has orally consented to the subject’s participation in the trial and, if capable of doing so, has signed
p.000034: and personally dated the informed consent form, the witness should sign and personally date the consent form. By
p.000034: signing the consent form, the witness attests that the information in the consent form and any other written
p.000034: information was accurately explained to, and apparently understood by, the subject or the subject's legally acceptable
p.000034: representative, and that informed consent was freely given by the subject or the subject’s legally
p.000034: acceptable representative.
p.000034:
p.000034:
p.000034:
p.000035: 35
p.000035:
p.000035: 4.8.10 Both the informed consent discussion and the written informed consent form and any other written
p.000035: information to be provided to subjects should include explanations of the following:
p.000035: (a) That the trial involves research.
p.000035: (b) The purpose of the trial.
p.000035: (c) The trial treatment(s) and the probability for random assignment to each treatment.
p.000035: (d) The trial procedures to be followed, including all invasive procedures.
p.000035: (e) The subject's responsibilities.
p.000035: (f) Those aspects of the trial that are experimental.
p.000035: (g) The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or
p.000035: nursing infant.
p.000035: (h) The reasonably expected benefits. When there is no intended clinical benefit to the subject, the subject should be
p.000035: made aware of this.
p.000035: (i) The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important
p.000035: potential benefits and risks.
p.000035: (j) The compensation and/or treatment available to the subject in the event of trial-related injury.
p.000035: (k) The anticipated prorated payment, if any, to the subject for participating in the trial.
p.000035: (l) The anticipated expenses, if any, to the subject for participating in the trial.
p.000035: (m) That the subject's participation in the trial is voluntary and that the subject may refuse to participate or
p.000035: withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
p.000035: (n) That the monitor(s), the auditor(s), the IRB/IEC, and PBSL will be granted direct access to the
p.000035: subject's original medical records for verification of clinical trial procedures and/or data, without violating the
p.000035: confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by
p.000035: signing a written informed consent form, the subject or the subject's legally acceptable representative is authorizing
p.000035: such access.
p.000035: (o) That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws
...
Social / employees
Searching for indicator employees:
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p.000010: Unexpected Adverse Drug Reaction
p.000010: An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g.,
p.000010: Investigator's Brochure for an unapproved investigational product or package insert/summary of product
p.000010: characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and
p.000010: Standards for Expedited Reporting).
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
...
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
p.000026: • the study of the possible causes, effects, and processes of incarceration, and of criminal behaviour,
p.000026: provided;
p.000026: • no more than minimal risk and inconvenience to the participants;
p.000026: • the study of prisons as institutional structures or of prisoners as incarcerated persons,
p.000026: • research on conditions particularly affecting prisoners as a class (for example, vaccine trials and
p.000026: other research on diseases that may be more prevalent in prisons and research on social and psychological
p.000026: problems such as alcoholism, drug addiction, and sexual assaults) only after appropriate experts have been
p.000026: consulted; and
p.000026:
p.000026:
p.000026:
...
Social / gender
Searching for indicator gender:
(return to top)
p.000062: in animal species.
p.000062: (c) Toxicology
p.000062: A summary of the toxicological effects found in relevant studies conducted in different animal species should be
p.000062: described under the following headings where appropriate:
p.000062: − Single dose
p.000062:
p.000062: − Repeated dose
p.000062:
p.000062: − Carcinogenicity
p.000062:
p.000062: − Special studies (e.g. irritancy and sensitisation)
p.000062:
p.000062: − Reproductive toxicity
p.000062:
p.000062: − Genotoxicity (mutagenicity)
p.000062:
p.000062:
p.000062: 7.3.6 Effects in Humans Introduction:
p.000062: A thorough discussion of the known effects of the investigational product(s) in
p.000062: humans should be provided, including information on pharmacokinetics, metabolism, pharmacodynamics,
p.000062: dose response, safety, efficacy, and other pharmacological activities. Where possible, a summary of each
p.000062: completed clinical trial should be provided. Information should also be provided regarding results of any use of the
p.000062: investigational product(s) other than from in clinical trials, such as from experience during marketing.
p.000062: (a) Pharmacokinetics and Product Metabolism in Humans
p.000062: − A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the
p.000062: following, if available:
p.000062: − Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution,
p.000062: and elimination).
p.000062: − Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference
p.000062: dosage form.
p.000062: − Population subgroups (e.g., gender, age, and impaired organ function).
p.000062:
p.000063: 63
p.000063:
p.000063: − Interactions (e.g., product-product interactions and effects of food).
p.000063:
p.000063: − Other pharmacokinetic data (e.g., results of population studies performed within clinical trial(s).
p.000063:
p.000063:
p.000063: (b) Safety and Efficacy
p.000063: A summary of information should be provided about the investigational product's/products' (including
p.000063: metabolites, where appropriate) safety, pharmacodynamics, efficacy, and dose response that were
p.000063: obtained from preceding trials in humans (healthy volunteers and/or patients). The implications of
p.000063: this information should be discussed. In cases where a number of clinical trials have been completed, the use
p.000063: of summaries of safety and efficacy across multiple trials by indications in subgroups may provide a clear
p.000063: presentation of the data. Tabular summaries of adverse drug reactions for all the clinical trials (including those
p.000063: for all the studied indications) would be useful. Important differences in adverse drug reaction
p.000063: patterns/incidences across indications or subgroups should be discussed.
p.000063: The IB should provide a description of the possible risks and adverse drug reactions to be anticipated on
p.000063: the basis of prior experiences with the product under investigation and with related products. A description
...
Social / parents
Searching for indicator parent:
(return to top)
p.000022: guidelines); or
p.000022: • The research interventions present more than minimal risk but hold out the prospect of direct benefit for the
p.000022: participant. The risks must be justified by the anticipated benefit; or
p.000022: • The research interventions, including those in observational research, present more than minimal risk and do
p.000022: not hold out the prospect of direct benefit to the participant, but have a high probability of yielding
p.000022: generalizable knowledge. That is the risk should be justified by the risk-knowledge ratio. The risk should represent a
p.000022: minor increase over minimal risk. The intervention or procedure should present experiences to participants that are
p.000022: reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or
p.000022: education settings.
p.000022: • In all cases, the protocol must provide sufficient information to justify clearly why minors should be included as
p.000022: participants.
p.000022:
p.000022: 3.4.1.1 Consent Requirements: For research with minors, the following should be obtained:
p.000022: •Consent from a parent or legal guardian in all but exceptional circumstances (e.g. emergencies). A caregiver
p.000022: (e.g. custodian, person providing long-term day-to-day care for the child) can act on behalf of a minor;
p.000022: •Assent from the minor where s/he is capable of understanding;
p.000022: •A child's refusal to participate in research must be respected, i.e. such refusal settles the matter
p.000022:
p.000023: 23
p.000023:
p.000023: 3.4.1.2 Assent Requirements: Assent means a minor's affirmative agreement to participate in research. Mere
p.000023: failure to object should not be construed as assent. The research ethics committee must ensure that adequate steps are
p.000023: outlined in the protocol to obtain the minor's assent when, in the judgement of the research ethics committee, the
p.000023: minor is capable of providing such assent. When the research ethics committee decides that assent is required, it
p.000023: must also indicate whether and how such assent must be documented.
p.000023: 3.4.2 Women: Exclusion of women as research participants has led to a lack of data needed to promote
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
p.000006: Independent Data-Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data
p.000006: Monitoring Committee)
p.000006: An independent data-monitoring committee that may be established by the sponsor to assess at intervals the
p.000006: progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor
p.000006: whether to continue, modify, or stop a trial.
p.000006: Impartial Witness
p.000006: A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who
p.000006: attends the informed consent process if the subject or the subject’s legally acceptable representative
p.000006: cannot read, and who reads the informed consent form and any other written information supplied to the subject.
p.000006: Independent Ethics Committee (IEC)
p.000006: An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted
p.000006: of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the
p.000006: rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection,
p.000006: by, among other things, reviewing and approving / providing favourable opinion on, the trial protocol, the suitability
p.000006: of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed
p.000006: consent of the trial subjects.
p.000006: Informed Consent
p.000006: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after
p.000006: having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed
p.000006: consent is documented by means of a written, signed and dated informed consent form.
p.000006: Inspection
p.000006: The act by PBSL of conducting an official review of documents, facilities, records, and any other resources that are
p.000006: deemed by the Board to be related to the clinical trial and that may be located at the site of the trial, at the
p.000006: sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by
p.000006: the Board.
p.000006: Institution (medical)
p.000006: Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
p.000006:
p.000006:
p.000006: Institutional Review Board (IRB)
p.000006: An independent body constituted of medical, scientific, and non-scientific members,
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects
p.000007: involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial
...
p.000007: of the investigational product(s) in human subjects (see section7. Investigator’s Brochure).
p.000007: Legally Acceptable Representative
p.000007: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective
p.000007: subject, to the subject's participation in the clinical trial.
p.000007:
p.000007:
p.000007: Local Monitor A person appointed by the Sponsor or CRO to oversee the progress of a clinical trial and of ensuring that
p.000007: it is conducted, recorded and reported in accordance with the SOPs, GCP and the applicable regulatory requirements.
p.000007:
p.000007:
p.000007: Monitoring
p.000007: The act of overseeing the progress of a clinical trial either by PBSL or an independent monitor selected by the sponsor
p.000007: to ensure that it is conducted, recorded, and reported in
p.000007:
p.000008: 8
p.000008:
p.000008: accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
p.000008: applicable regulatory requirement(s).
p.000008:
p.000008:
p.000008: Monitoring Report
p.000008: A written report from the monitor to the sponsor after each site visit and/or other trial-related
p.000008: communication according to the sponsor’s SOPs.
p.000008: Monitoring Plan
p.000008: A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial.
p.000008: Multicentre Trial
p.000008: A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more
p.000008: than one investigator.
p.000008: Nonclinical Study
p.000008: Biomedical studies not performed on human subjects.
p.000008: Opinion (in relation to Independent Ethics Committee)
p.000008: The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
p.000008: Original Medical Record
p.000008: See Source Documents.
p.000008: PBSL means Pharmacy Board of Sierra Leone
p.000008: Placebo A medication with no active ingredients or a procedure without any medical benefit.
p.000008: Principal Investigator / Investigator The person responsible for the conduct of the clinical trial at the clinical
p.000008: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000008: located.
p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
p.000009: the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the
p.000009: applicable regulatory requirement(s).
p.000009: Quality Control (QC)
p.000009: The operational techniques and activities undertaken within the quality assurance system to verify that the
...
p.000012: 1.2 PRINCIPLES
p.000012:
p.000012: Although well-designed clinical trials will undoubtedly fit in within these modern ethical sentiments, the potential to
p.000012: violate the rights of trial participants particularly in vulnerable communities necessitates the need to articulate
p.000012: ethical guidelines for clinical trials.
p.000012: The principles of GCP include:
p.000012:
p.000012: 1) Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
p.000012: Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
p.000012: 2) Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
p.000012: benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated
p.000012: benefits justify the risks.
p.000012: 3) The rights, safety, and well-being of the trial subjects are the most important considerations and
p.000012: should prevail over interests of science and society.
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: 4) The available nonclinical and clinical information on an investigational product should be adequate to
p.000013: support the proposed clinical trial.
p.000013: 5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
p.000013: 6) A trial should be conducted in compliance with the protocol that has received prior institutional review
p.000013: board (IRB)/independent ethics committee (IEC) approval/favourable opinion.
p.000013: 7) The medical care given to, and medical decisions made on behalf of, subjects should always be the
p.000013: responsibility of a qualified physician or, when appropriate, of a qualified dentist.
p.000013: 8) Each individual involved in conducting a trial should be qualified by education, training, and experience to
p.000013: perform his or her respective task(s).
p.000013: 9) Freely given informed consent should be obtained from every subject prior to clinical trial
p.000013: participation.
p.000013: 10) All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting,
p.000013: interpretation and verification.
p.000013: 11) The confidentiality of records that could identify subjects should be protected, respecting the privacy
p.000013: and confidentiality rules in accordance with the applicable regulatory requirement(s).
p.000013: 12) Investigational products should be manufactured, handled, and stored in accordance with applicable
p.000013: good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
p.000013: 13) Systems with procedures that assure the quality of every aspect of the trial should be implemented.
p.000013: The practical application of these principles requires research studies to have distinct components built
p.000013: into them. These include relevant and appropriate study rationale, optimal study design, investigator
p.000013: competence, a balance of risks and benefits for participants, transparency, patient privacy, ethical review
...
p.000019: • SLERSC Approval: All clinical trials to be conducted in Sierra Leone must apply for and receive ethical approval
p.000019: from the ethics committee
p.000019: 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000019: 3.1 RESPONSIBILITIES
p.000019: 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be
p.000019: paid to trials that may include vulnerable subjects.
p.000019: 3.1.2 The IRB/IEC should obtain the following documents:
p.000019:
p.000019: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator
p.000019: proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be
p.000019: provided to subjects, Investigator's Brochure (IB), available safety information, information about payments
p.000019: and compensation available to subjects, the investigator’s current curriculum vitae and/or other
p.000019: documentation evidencing qualifications, and any other documents that the IRB/IEC may need to fulfill its
p.000019: responsibilities.
p.000019: The IRB/IEC should review a proposed clinical trial within a reasonable time and document its views in writing, clearly
p.000019: identifying the trial, the documents reviewed and the dates for the following:
p.000019: - approval/favourable opinion;
p.000019: - modifications required prior to its approval/favourable opinion;
p.000019: - disapproval / negative opinion; and
p.000019: - termination/suspension of any prior approval/favourable opinion.
p.000019:
p.000019:
p.000019: 3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a
p.000019: current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: 3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk
p.000020: to human subjects, but at least once per year.
p.000020: 3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when,
p.000020: in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of
p.000020: the rights, safety and/or well-being of the subjects.
p.000020: 3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable
p.000020: representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol
p.000020: and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory
p.000020: requirements for such trials.
p.000020: 3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable
p.000020: representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or
p.000020: other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for
p.000020: such trials (i.e. in emergency situations).
p.000020: 3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents
p.000020: problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly
p.000020: contingent on completion of the trial by the subject.
p.000020: 3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods,
p.000020: amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other
p.000020: written information to be provided to subjects. The way payment will be prorated should be specified.
p.000020: 3.2 COMPOSITION, FUNCTIONS AND OPERATIONS
p.000020: 3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and
p.000020: experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended
p.000020: that the IRB/IEC should include:
p.000020: (a) At least five members.
p.000020: (b) At least one member whose primary area of interest is in a nonscientific area.
p.000020: (c) At least one member who is independent of the institution/trial site.
p.000020: Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should
p.000020: vote/provide opinion on a trial-related matter.
p.000020: A list of IRB/IEC members and their qualifications should be maintained.
p.000020:
p.000021: 21
p.000021:
p.000021: 3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written
p.000021: records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory
p.000021: requirement(s).
p.000021: 3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its
p.000021: written operating procedures, is present.
p.000021: 3.2.4 Only members who participate in the IRB/IEC review and discussion should vote/provide their opinion
p.000021: and/or advise.
p.000021: 3.3 RECORDS
p.000021: The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of
p.000021: occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
...
p.000027: prison(s) involved, apart from their membership of the research ethics committee;
p.000027: • At least one member of the research ethics committee shall be a prisoner, or a prisoners'
p.000027: representative with appropriate background and experience to serve in that capacity. Where a research project is
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
p.000027: be conducted in strict accordance with the principles set out in the section entitled Research Involving Children.
p.000027: These principles do not permit research that is contrary to the child's best interests.
p.000027: The small size and vulnerability of some infants are unique features of this research, which renders all but
p.000027: minimal intrusion likely to be contrary to the child's best
p.000027:
...
p.000032: with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during
p.000032: the trial, the investigator should supply a copy of the updated Investigator’s Brochure to PBSL.
p.000032: 4.4.3 During the trial the investigator should provide PBSL all documents subject to review.
p.000032: 4.5 Compliance with Protocol
p.000032: 4.5.1 The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, which
p.000032: was given approval by PBSL. The investigator and the sponsor should sign the protocol, or an alternative
p.000032: contract, to confirm agreement.
p.000032: 4.5.2 The investigator should not implement any deviation from, or changes of the protocol without prior review and
p.000032: approval from PBSL of an amendment, except where necessary to eliminate an immediate hazard(s) to trial
p.000032: subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in
p.000032: monitor(s), change of telephone number(s)).
p.000032: 4.5.3 The investigator, or person designated by the investigator, should document and explain any deviation
p.000032: from the approved protocol.
p.000032: 4.5.4 The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s)
p.000032: to trial subjects without prior PBSL approval. As soon as possible, the implemented deviation or change, the reasons
p.000032: for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
p.000032: (a) to the IRB/IEC for review and approval/favourable opinion,
p.000032: (b) to the sponsor for agreement and, if required,
p.000032: (c) to PBSL review and approval.
p.000032: 4.6 Investigational Product(s)
p.000032: 4.6.1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator.
p.000032: 4.6.2 The investigator should assign some or all of the investigator's duties for
p.000032: investigational product(s) accountability at the trial site(s) to an appropriate pharmacist who is under the
p.000032: supervision of the investigator.
p.000032: 4.6.3 The investigator and/or a pharmacist who is designated by the investigator should maintain records of the
p.000032: product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor
p.000032: or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s)
p.000033: and trial subjects. Investigators should maintain records that document adequately that the subjects were
p.000033: provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
p.000033: 4.6.4 The investigational product(s) should be stored as specified by the sponsor (see
p.000033: 5.13.2 and 5.14.3) and in accordance with applicable regulatory requirement(s).
p.000033: 4.6.5 The investigator should ensure that the investigational product(s) are used only in accordance with the approved
p.000033: protocol.
p.000033: 4.6.6 The investigator, or a person designated by the investigator/institution, should explain the correct
p.000033: use of the investigational product(s) to each subject and should check, at intervals appropriate for the trial,
p.000033: that each subject is following the instructions properly.
p.000033: 4.7 Randomization Procedures and Unblinding
p.000033:
p.000033: The investigator should follow the trial's randomization procedures, if any, and should ensure that the code
p.000033: is broken only in accordance with the protocol. If the trial is blinded, the investigator should promptly document
p.000033: and explain to the sponsor any premature unblinding (e.g., accidental unblinding, unblinding due to a serious
p.000033: adverse event) of the investigational product(s).
p.000033: 4.8 Informed Consent of Trial Subjects
p.000033: 4.8.1 In obtaining and documenting informed consent, the investigator should comply with the applicable
p.000033: regulatory requirement(s) such as PBSL requirements and should adhere to GCP and to the ethical principles
p.000033: that have their origin in the Declaration of Helsinki(see Appendix 3 of this Guideline). Prior to the beginning
p.000033: of the trial, the investigator should have the IRB/IEC's written approval/favourable opinion of the written informed
p.000033: consent form and any other written information to be provided to subjects.
p.000033: 4.8.2 The written informed consent form and any other written information to be provided to subjects should be
p.000033: revised whenever important new information becomes available that may be relevant to the subject’s
p.000033: consent. Any revised written informed consent form, and written information should receive PBSL approval in advance
p.000033: of use. The subject or the subject’s legally acceptable representative should be informed in a timely manner
p.000033: if new information becomes available that may be relevant to the subject’s willingness to continue participation in the
p.000033: trial. The communication of this information should be documented.
p.000033: 4.8.3 Neither the investigator, nor the trial staff, should coerce or unduly influence a
p.000033:
p.000034: 34
p.000034:
p.000034: subject to participate or to continue to participate in a trial.
p.000034: 4.8.4 None of the oral and written information concerning the trial, including the written informed consent form,
p.000034: should contain any language that causes the subject or the subject's legally acceptable representative to waive or to
p.000034: appear to waive any legal rights, or that releases or appears to release the investigator, the institution,
p.000034: the sponsor, or their agents from liability for negligence.
...
p.000036: written informed consent form.
p.000036: 4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable
p.000036: representative provided the following conditions are fulfilled:
p.000036: (a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent
p.000036: personally.
p.000036: (b) The foreseeable risks to the subjects are low.
p.000036: (c) The negative impact on the subject’s well-being is minimized and low.
p.000036: (d) The trial is not prohibited by law.
p.000036: Such trials, unless an exception is justified, should be conducted in patients having a disease or
p.000036: condition for which the investigational product is intended. Subjects in these trials should be particularly closely
p.000036: monitored and should be withdrawn if they appear to be
p.000036:
p.000037: 37
p.000037:
p.000037: unduly distressed.
p.000037:
p.000037: 4.8.15 In emergency situations, when prior consent of the subject is not possible, the consent of the
p.000037: subject's legally acceptable representative, if present, should be requested. When prior consent of the
p.000037: subject is not possible, and the subject’s legally acceptable representative is not available, enrollment of the
p.000037: subject should require measures described in the protocol and/or elsewhere, with documented
p.000037: approval/favourable opinion by the IRB/IEC and PBSL approval, to protect the rights, safety and well-being
p.000037: of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's
p.000037: legally acceptable representative should be informed about the trial as soon as possible and consent to continue and
p.000037: other consent as appropriate (see 4.8.10) should be requested.
p.000037: 4.9 Records and Reports
p.000037: 4.9.0 The investigator/institution should maintain adequate and accurate source documents and trial records that
p.000037: include all pertinent observations on each of the site’s trial subjects. Source data should be attributable,
p.000037: legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable,
p.000037: should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).
p.000037: 4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the
p.000037: sponsor in the CRFs and in all required reports.
p.000037: 4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the
p.000037: source documents or the discrepancies should be explained.
p.000037: 4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not
p.000037: obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic
p.000037: changes or corrections (see
p.000037: 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated
...
p.000069: X X
p.000069:
p.000069:
p.000069:
p.000069: To document the informed consent
p.000069:
p.000069: To document that subjects will be given appropriate written information (content and wording) to support their ability
p.000069: to give fully informed consent
p.000069:
p.000069: To document that recruitment measures are appropriate and not coercive
p.000069:
p.000069:
p.000069:
p.000069: 4. FINANCIAL ASPECTS OF THE TRIAL
p.000069: To document the financial X X agreement between the
p.000069: investigator/institution and the sponsor for the trial
p.000070: 70
p.000070:
p.000070:
p.000070:
p.000070: NO. Title of Document Purpose
p.000070: Located in File
p.000070:
p.000070: Investigator/I nstitution
p.000070: Sponsor
p.000070:
p.000070: 5. INSURANCE STATEMENT
p.000070: (where required)
p.000070:
p.000070: 6. SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:
p.000070: - investigator/institution and sponsor
p.000070:
p.000070: - investigator/institution and CRO
p.000070: -sponsor and CRO
p.000070: -investigator/institution and authority(ies) (where required)
p.000070: To document that compensation X X to subject(s) for trial-related
p.000070: injury will be available To document agreements
p.000070:
p.000070: X X
p.000070:
p.000070: X X
p.000070: (where required)
p.000070: X
p.000070:
p.000070: X X
p.000070:
p.000070: 7. DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000070: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000070: -Protocol and any amendments
p.000070: -CRF (if applicable)
p.000070: -Informed consent form(s)
p.000070: -Any other written information to be provided to the subject(s)
p.000070: - Advertisement for subject recruitment
p.000070: (if used)
p.000070: -Subject compensation (if any)
p.000070: - Any other documents given approval/ favourable opinion
p.000070: To document that the trial has X X been subject to IRB/IEC review
p.000070: and given approval/favourable opinion. To identify the version number and date of the document(s)
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: Investigator/I nstitution
p.000071: Sponsor
p.000071:
p.000071: 8. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION
p.000071:
p.000071: 9. PBSL
p.000071: AUTHORISATION/APPROVAL/
p.000071: NOTIFICATION OF PROTOCOL
p.000071: (where required)
p.000071: To document that the X X IRB/IEC is constituted in
p.000071: agreement with GCP
p.000071:
p.000071:
p.000071: To document appropriate X X authorisation/approval/notifi
p.000071: cation by PBSL has been obtained prior to initiation of the trial in compliance with the applicable regulatory
p.000071: requirement(s)
p.000071:
p.000071:
p.000071: 10. CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND
p.000071: SUB-INVESTIGATOR(S)
p.000071: To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
p.000071: X
p.000071:
p.000071: (where required)
p.000071: X
p.000071:
p.000071: (where required)
p.000071:
p.000071:
p.000071:
p.000071: 11. NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE
p.000071: PROTOCOL
p.000071: To document normal values X X and/or ranges of the tests
p.000071:
p.000071:
p.000071: 12. MEDICAL/LABORATORY/TEC HNICAL PROCEDURES /TESTS
p.000071: - certification or
p.000071: - accreditation or
p.000071: - established quality control and/or external quality assessment or
p.000071: - other validation (where required)
...
p.000073:
p.000073: X
p.000073: (third party if applicable
p.000073: X
p.000073:
p.000073:
p.000073: 20. TRIAL INITIATION MONITORING REPORT
p.000073:
p.000073:
p.000073: During the Clinical Conduct of the Trial
p.000073: To document that trial procedures X X were reviewed with the investigator
p.000073: and the investigator’s trial staff ( may be combined with 19)
p.000073: In addition to having on file the above documents the following should be added to the files during the trial as
p.000073: evidence that all new relevant information is documented as it becomes available.
p.000073:
p.000073: 21. INVESTIGATOR’S BROCHURE UPDATE
p.000073: To document that investigator is X X informed in a timely manner of
p.000073: relevant information as it becomes available
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: NO. Title of Document Purpose
p.000074: Located in Files of
p.000074:
p.000074:
p.000074: Investigator/ Institution
p.000074: Sponsor
p.000074:
p.000074: 22. ANY REVISION TO:
p.000074: -Protocol/amendment(s) and CRF
p.000074: -Informed consent form any other written
p.000074: -Information provided to subjects
p.000074: -Advertisement for subject recruitment
p.000074: used)
p.000074: 23. DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000074: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000074: Protocol amendment(s)
p.000074: -Revision(s) of:
p.000074: ✓ informed consent form
p.000074: ✓ any other written information to be provided to the subject
p.000074: ✓ advertisement for subject recruitment if used)
p.000074: Any other documents given approval/favourable opinion
p.000074: - Continuing review of trial (where required)
p.000074: To document revisions of these X X trial related documents that take
p.000074: effect during trial
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074: To document that the X X amendment(s) and/or revision(s)
p.000074: have been subject to IRB/IEC review and were given approval/favourable opinion. To identify the version number and date
p.000074: of the document(s).
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000075: 75
p.000075:
p.000075: NO. Title of Document Purpose
p.000075: Located in File
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: 24. PBSL AUTHORISATIONS/APPR OVALS/NOTIFICATIONS WHERE REQUIRED FOR:
p.000075: - Protocol amendment(s) and other documents
p.000075:
p.000075:
p.000075: To document compliance with applicable regulatory requirements
p.000075: Investigator/I nstitution
p.000075: X
p.000075: (where required)
p.000075: Sponsor
p.000075:
p.000075: X
p.000075:
p.000075:
p.000075: 25. CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR
p.000075: SUB-INVESTIGATOR(S)
p.000075: (see 10) X X
p.000075:
p.000075:
p.000075: 26. UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S) INCLUDED IN
p.000075: THE PROTOCOL
p.000075:
p.000075: 27 UPDATES OF MEDICAL/LABORATORY
p.000075: / TECHNICAL PROCEDURES/TESTS
p.000075: -Certification or
p.000075: -Accreditation or
p.000075: -Established quality control and/or external quality assessment or
p.000075: - Other validation (where required)
p.000075: To document normal values and ranges that are revised during the trial (see 11)
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: To document that tests remain adequate throughout the trial period (see 12)
p.000075: X X
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075:
p.000075: X X
p.000075: (where required)
p.000075:
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000021: least 3 years after completion of the trial and make them available upon request from PBSL.
p.000021: The IRB/IEC may be asked by investigators, sponsors or PBSL to provide its written procedures and
p.000021: membership lists.
p.000021: 3.4 RESEARCH REQUIRING ADDITIONAL ATTENTION
p.000021:
p.000021: The Sierra Leone national research ethics committee must pay special attention to protecting the welfare of
p.000021: certain classes of participants. Research ethics committees may impose additional measures to protect the welfare
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
...
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
p.000026: • employees and employers, e.g. farm workers and their employers, members of the uniformed services and hospital
p.000026: staff and their employers.
p.000026:
p.000026: 3.4.5 Prisoners: Ethical review must take cognisance of the impact of a prisoner's incarceration on their
p.000026: ability to make a voluntary decision, without coercion, on whether or not to participate in research. Research studies
p.000026: in Sierra Leone may involve prisoners as participants only when the ethics committee has ensured that the clinical
p.000026: trial involves:
...
p.000027: research. Research ethics committees should take into consideration the extent to which research facilitates the
p.000027: empowerment of prisoners as a vulnerable group.
p.000027: In addition, when reviewing research involving prisoners, research ethics committees must meet the following
p.000027: requirements:
p.000027: • A majority of the research ethics committee, other than prison members, shall have no association with the
p.000027: prison(s) involved, apart from their membership of the research ethics committee;
p.000027: • At least one member of the research ethics committee shall be a prisoner, or a prisoners'
p.000027: representative with appropriate background and experience to serve in that capacity. Where a research project is
p.000027: reviewed by more than one ethics committee, only one research ethics committee need satisfy this requirement of a
p.000027: prisoners' representative.
p.000027:
p.000027: 3.4.6 Persons Highly Dependent on Medical Care: The involvement in research of participants who are highly
p.000027: dependent on medical care raises ethical issues that deserve special attention. The gravity of their medical condition
p.000027: may require invasive measures carrying increased risk. Researchers need to acknowledge that informed consent may be
p.000027: compromised by the effect of the medical condition on the participant's capacity to form an opinion or to
p.000027: communicate. Additionally, there may be a perception of coercion if a participant is reluctant to refuse
p.000027: consent for fear that it may compromise his or her medical treatment. Researchers need to consider whether an unfair
p.000027: burden of participation is being placed on groups such as those referred to below.
p.000027: 3.4.6.1 Intensive Care Research: Characteristic features of intensive care research are the difficulties in
p.000027: communicating with patients receiving ventilatory assistance and the impairment of cognition in heavily sedated
p.000027: individuals. Whenever possible, information regarding intensive care research should be obtained from
p.000027: potential participants before their admission to that care. Because of their extreme vulnerability such persons
p.000027: should be excluded from all but minimally invasive observational research.
p.000027: 3.4.6.2 Neonatal Intensive Care Research: Research involving infants receiving neonatal intensive care should
...
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
p.000028: the participant's representative is able to give consent in advance, a research ethics committee may approve a research
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: • adequate provision will be made for informing patients and their relatives about the research, to ensure that
p.000029: stress and other emotional factors do not impair their understanding of it; and
p.000029: • the dependency of patients and their relatives on the medical personnel providing treatment does not affect any
p.000029: decision to participate.
p.000029: 3.4.7 Emergency Care Research: The benefits of emergency care research include improved effective treatment
p.000029: for life-threatening conditions and improving therapies for survival and quality of life. Research into emergency
p.000029: medical treatment needs to involve participants who are experiencing medical emergencies.
p.000029: The distinguishing feature of emergency care research however is that consent to commence a project usually
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
...
p.000082: precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the
p.000082: subject's physical and mental integrity and on the personality of the subject.
p.000082: 7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that
p.000082: the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found
p.000082: to outweigh the potential benefits.
p.000082: 8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the
p.000082: results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be
p.000082: accepted for publication.
p.000082: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000082: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000082: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000082: his or her consent to participation at any time. The physician should then obtain the subject's freely-given
p.000082:
p.000083: 83
p.000083:
p.000083: informed consent, preferably in writing.
p.000083:
p.000083: 10. When obtaining informed consent for the research project the physician should be particularly cautious
p.000083: if the subject is in a dependent relationship to him or her or mayconsent under duress. In that case
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
p.000009: the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the
p.000009: applicable regulatory requirement(s).
p.000009: Quality Control (QC)
p.000009: The operational techniques and activities undertaken within the quality assurance system to verify that the
p.000009: requirements for quality of the trial-related activities have been fulfilled.
p.000009: Randomization
p.000009: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the
p.000009: assignments in order to reduce bias.
p.000009: Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
p.000009: Any untoward medical occurrence that at any dose:
p.000009: - results in death,
p.000009: - is life-threatening,
p.000009: - requires inpatient hospitalization or prolongation of existing hospitalization,
p.000009: - results in persistent or significant disability/incapacity, or
p.000009: - is a congenital anomaly/birth defect
p.000009: (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
p.000009: Source Data
p.000009: All information in original records and certified copies of original records of clinical findings,
p.000009: observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
p.000009: Source data are contained in source documents (original records or certified copies).
p.000009: Source Documents
p.000009: Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes,
p.000009: memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from
p.000009: automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches,
p.000009: photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the
p.000009: laboratories and at medico-technical departments involved in the clinical trial).
p.000009: Sponsor
p.000009: An individual, company, institution, or organization which takes responsibility for the initiation,
p.000009: management, and/or financing of a clinical trial.
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010:
p.000010: Sponsor-Investigator
p.000010: An individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate
p.000010: direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include
p.000010: any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a
p.000010: sponsor-investigator include both those of a sponsor and those of an investigator.
...
p.000028: of participants and potential vulnerability to unrealistic expectations of benefits.
p.000028: Researchers must take care that the prospect of benefit from research participation is neither exaggerated nor used to
p.000028: justify a higher risk than that involved in the patient's current treatment.
p.000028: Researchers must respect the needs and wishes of participants to spend time as they choose, particularly with family
p.000028: members
p.000028: 3.4.6.4 Research Involving Persons with Impaired Capacity to Communicate: The distinguishing features of
p.000028: research involving persons with impaired capacity to communicate include acute impairment states requiring
p.000028: medical care, as well as non-acute states. In the former, the condition and medical care may mask the person's
p.000028: degree of cognition and require different means of expression. In the latter, the condition may be such as
p.000028: to prevent the person expressing wishes at all.
p.000028: 3.4.6.5 Research Involving Unconscious Persons: The distinguishing feature of research with unconscious persons
p.000028: is that, because of their incapacity for cognition or communication, it is impossible for them to be informed about the
p.000028: research or for a researcher to determine their wishes about it. Consent to participation in research by an unconscious
p.000028: person must be given by others, including relevant statutory authorities, on that person's behalf. Because of their
p.000028: extreme vulnerability unconscious persons should be excluded from all but minimally invasive observational research.
p.000028: When research procedure precludes conformity to the principle of consent, and neither the prospective participant nor
p.000028: the participant's representative is able to give consent in advance, a research ethics committee may approve a research
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
...
p.000082: results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be
p.000082: accepted for publication.
p.000082: 9. In any research on human beings, each potential subject must be adequately informed of the aims, methods,
p.000082: anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be
p.000082: informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw
p.000082: his or her consent to participation at any time. The physician should then obtain the subject's freely-given
p.000082:
p.000083: 83
p.000083:
p.000083: informed consent, preferably in writing.
p.000083:
p.000083: 10. When obtaining informed consent for the research project the physician should be particularly cautious
p.000083: if the subject is in a dependent relationship to him or her or mayconsent under duress. In that case
p.000083: the informed consent should be obtained by a physician who Is not engaged in the investigation and who is
p.000083: completely independent of this official relationship.
p.000083: 11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with
p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
p.000083: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
...
General/Other / Natural Hazards
Searching for indicator hazard:
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p.000031: the investigator becomes aware.
p.000031: 4.3.3 It is recommended that the investigator inform the subject's primary physician about the subject's participation
p.000031: in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
p.000031: 4.3.4 Although a subject is not obliged to give his/her reason(s) for withdrawing prematurely from a
p.000031: trial, the investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the
p.000031: subject's rights.
p.000031:
p.000031:
p.000031: 4.4 Communication with PBSL
p.000031: 4.4.1 Before initiating a trial, the principal investigator should have the written and dated approval from the PBSL
p.000031:
p.000032: 32
p.000032:
p.000032: 4.4.2 As part of the investigator written application to PBSL, the investigator should provide PBSL
p.000032: with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during
p.000032: the trial, the investigator should supply a copy of the updated Investigator’s Brochure to PBSL.
p.000032: 4.4.3 During the trial the investigator should provide PBSL all documents subject to review.
p.000032: 4.5 Compliance with Protocol
p.000032: 4.5.1 The investigator should conduct the trial in compliance with the protocol agreed to by the sponsor and, which
p.000032: was given approval by PBSL. The investigator and the sponsor should sign the protocol, or an alternative
p.000032: contract, to confirm agreement.
p.000032: 4.5.2 The investigator should not implement any deviation from, or changes of the protocol without prior review and
p.000032: approval from PBSL of an amendment, except where necessary to eliminate an immediate hazard(s) to trial
p.000032: subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in
p.000032: monitor(s), change of telephone number(s)).
p.000032: 4.5.3 The investigator, or person designated by the investigator, should document and explain any deviation
p.000032: from the approved protocol.
p.000032: 4.5.4 The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s)
p.000032: to trial subjects without prior PBSL approval. As soon as possible, the implemented deviation or change, the reasons
p.000032: for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
p.000032: (a) to the IRB/IEC for review and approval/favourable opinion,
p.000032: (b) to the sponsor for agreement and, if required,
p.000032: (c) to PBSL review and approval.
p.000032: 4.6 Investigational Product(s)
p.000032: 4.6.1 Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator.
p.000032: 4.6.2 The investigator should assign some or all of the investigator's duties for
p.000032: investigational product(s) accountability at the trial site(s) to an appropriate pharmacist who is under the
p.000032: supervision of the investigator.
p.000032: 4.6.3 The investigator and/or a pharmacist who is designated by the investigator should maintain records of the
p.000032: product's delivery to the trial site, the inventory at the site, the use by each subject, and the return to the sponsor
p.000032: or alternative disposition of unused product(s). These records should include dates, quantities, batch/serial
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: numbers, expiration dates (if applicable), and the unique code numbers assigned to the investigational product(s)
p.000033: and trial subjects. Investigators should maintain records that document adequately that the subjects were
p.000033: provided the doses specified by the protocol and reconcile all investigational product(s) received from the sponsor.
p.000033: 4.6.4 The investigational product(s) should be stored as specified by the sponsor (see
p.000033: 5.13.2 and 5.14.3) and in accordance with applicable regulatory requirement(s).
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000010: Validation of Computerized Systems
p.000010: A process of establishing and documenting that the specified requirements of a computerized
p.000010: system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The
p.000010: approach to validation should be based on a risk assessment that takes into consideration the intended use of
p.000010: the system and the
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: potential of the system to affect human subject protection and reliability of trial results.
p.000011: Vulnerable Subjects/population
p.000011: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether
p.000011: justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a
p.000011: hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as
p.000011: medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the
p.000011: pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects
p.000011: include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons,
p.000011: patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and
p.000011: those incapable of giving consent.
p.000011: Well-being (of the trial subjects)
p.000011: The physical and mental integrity of the subjects participating in a clinical trial.
p.000011:
p.000011:
p.000011: 2. INTRODUCTION
p.000011:
p.000011: The value of carefully constructed clinical trials as the optimum methodology for the testing and
p.000011: evaluation of new treatments and medicines is well recognised within the Sierra Leone. Sierra Leone provides a
p.000011: particularly unique research environment encompassing world class expertise in clinical trial research, modern health
p.000011: care facilities, a significant burden of disease, and a stable political environment.
p.000011: Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting,
p.000011: recording, and reporting trials that involve the participation of human subjects. Compliance with this standard
p.000011: provides public assurance that the rights, safety, and wellbeing of trial subjects are protected, consistent with the
p.000011: principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.
p.000011: The purpose of this guideline is to provide investigators conducting clinical trials in Sierra Leone with clear
...
p.000019:
p.000019:
p.000019: 3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a
p.000019: current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: 3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk
p.000020: to human subjects, but at least once per year.
p.000020: 3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when,
p.000020: in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of
p.000020: the rights, safety and/or well-being of the subjects.
p.000020: 3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable
p.000020: representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol
p.000020: and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory
p.000020: requirements for such trials.
p.000020: 3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable
p.000020: representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or
p.000020: other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for
p.000020: such trials (i.e. in emergency situations).
p.000020: 3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents
p.000020: problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly
p.000020: contingent on completion of the trial by the subject.
p.000020: 3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods,
p.000020: amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other
p.000020: written information to be provided to subjects. The way payment will be prorated should be specified.
p.000020: 3.2 COMPOSITION, FUNCTIONS AND OPERATIONS
p.000020: 3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and
p.000020: experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended
p.000020: that the IRB/IEC should include:
p.000020: (a) At least five members.
p.000020: (b) At least one member whose primary area of interest is in a nonscientific area.
p.000020: (c) At least one member who is independent of the institution/trial site.
p.000020: Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should
p.000020: vote/provide opinion on a trial-related matter.
p.000020: A list of IRB/IEC members and their qualifications should be maintained.
p.000020:
p.000021: 21
p.000021:
...
p.000021: of participants requiring additional attention. For example, research ethics committees may make it
p.000021: mandatory to conduct post-research investigations to review whether there was compliance with the additional measures
p.000021: imposed. If compliance was defective, research ethics committees may withdraw approval for the research investigation
p.000021: concerned.
p.000021: Participants whose involvement needs additional attention include:
p.000021:
p.000021: • Minors: Children and adolescents
p.000021: • Women
p.000021: • People with mental disabilities or substance abuse related disorders
p.000021: • Persons in dependent relationships or comparable situations
p.000021: • Prisoners
p.000021: • Persons highly dependent on medical care
p.000021:
p.000021: Types of research that need additional attention include:
p.000021:
p.000021: • Research involving collectivities
p.000021: • Research involving indigenous medical systems
p.000021:
p.000022: 22
p.000022:
p.000022: • Emergency care research
p.000022: • Research involving innovative therapy or interventions
p.000022: • Research involving vulnerable communities
p.000022: • HIV and AIDS clinical and epidemiological research
p.000022: 3.4.1 Minors: Children and adolescents: A minor for the purposes of this guideline is defined as a person
p.000022: under 18 years of age. Minors should participate in research only where their participation is indispensable to
p.000022: the research. Where research involving minors is proposed, a research ethics committee should determine whether
p.000022: the research might be equally informative if carried out with consenting adults. If so, the research
p.000022: ethics committee should require strong justification for the inclusion of minors. The research should
p.000022: investigate a problem of relevance to children. Note that all types of clinical research on minors should
p.000022: be scrutinized carefully.
p.000022: Research involving minors should be approved only if:
p.000022: • The research interventions, including those in observational research, presents the participant with no greater
p.000022: than minimal risk (that is, the probability and magnitude of harm or discomfort anticipated in the research are
...
p.000028: project without prior consent if it is satisfied that:
p.000028: • inclusion in the research project is not contrary to the interest of the patient;
p.000028: • the research is intended to be therapeutic and the research intervention poses no more of a risk than that
p.000028: inherent in the patient's condition and alternative methods of treatment;
p.000028: • the research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.000028: standard care; and
p.000028: • as soon as reasonably possible, the participant and the participant's relatives or legal representatives will
p.000028: be informed of the participant's inclusion in the research, and will be advised of their right to
p.000028: withdraw from the research without any reduction in quality of care.
p.000028: In the case of research proposals in which it is practicable to obtain consent before including in the research a
p.000028: participant who is highly dependent on medical care, a research ethics committee must be satisfied that:
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: • adequate provision will be made for informing patients and their relatives about the research, to ensure that
p.000029: stress and other emotional factors do not impair their understanding of it; and
p.000029: • the dependency of patients and their relatives on the medical personnel providing treatment does not affect any
p.000029: decision to participate.
p.000029: 3.4.7 Emergency Care Research: The benefits of emergency care research include improved effective treatment
p.000029: for life-threatening conditions and improving therapies for survival and quality of life. Research into emergency
p.000029: medical treatment needs to involve participants who are experiencing medical emergencies.
p.000029: The distinguishing feature of emergency care research however is that consent to commence a project usually
p.000029: has to be obtained rapidly, when the vulnerability of patients and families is likely to be greatest. Because of their
p.000029: extreme vulnerability, such persons should be excluded from all but minimally invasive observational research.
p.000029: Research ethics committee must therefore take great care when assessing emergency care research.
p.000029: Moreover, the circumstances surrounding emergency care research are such that it may not always be possible to
p.000029: obtain consent for inclusion without delaying the initiation of treatment, and so risking a reduction of
p.000029: potential benefits. As such there may be circumstances in which it is not possible to obtain consent for
p.000029: inclusion in emergency care research. After a protocol has been presented by a researcher giving clear reasons to
p.000029: justify the initiation of the emergency care research without consent, a research ethics committee may approve the
p.000029: research without consent provided it is satisfied that:
p.000029: • reasonable steps are being taken to ascertain the religious and cultural sensitivities of patients experiencing
p.000029: medical emergencies;
p.000029: • the condition of the patient precludes the giving of consent;
p.000029: • inclusion in the trial is not contrary to the interests of the patient;
p.000029: • the research is intended to be therapeutic and poses no more risk than is inherent to the patient's condition or
p.000029: would be caused by alternative methods of treatment;
p.000029: • the patient and the patient's next of kin or legal representatives will be informed as soon as is reasonably
p.000029: possible of the patient's inclusion in the study and of the option to withdraw from the research project at any time;
p.000029: • the patient will be informed, and consent obtained, once the patient who has undergone the necessary
p.000029: emergency procedures has regained consciousness; and
p.000029: • the research is based on valid scientific hypotheses and offers a realistic possibility of benefit over standard
p.000029: care.
p.000029:
p.000029:
p.000029:
p.000029: 4. INVESTIGATOR
p.000029: 4.1 Investigator's Qualifications and Agreements
p.000029: 4.1.1 The investigator(s) should be qualified by education, training, and experience to
p.000029:
p.000030: 30
p.000030:
p.000030: assume responsibility for the proper conduct of the trial and should provide evidence of such qualifications and
p.000030: experience through an up to date Curriculum Vitae. The Principal investigator’s qualification should be in
p.000030: accordance with Section 3.2 sub-section 3.2.3 under the PBSL Guidelines for Conducting Clinical Trials.
p.000030: 4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational
p.000030: product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in
p.000030: other information sources provided by the sponsor.
p.000030: 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
p.000030: 4.1.4 The investigator should permit monitoring and auditing by PBSL.
p.000030: 4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated
p.000030: significant trial-related duties.
p.000030: 4.1.6 The Investigator should not have been found guilty of any misconduct under the Sierra Leone Medical
p.000030: and Dental Council.
p.000030: 4.1.7 The Principal Investigator must be an appropriately qualified and competent person having practical experience
...
p.000036: severe dementia), the subject should be informed about the trial to the extent compatible with the
p.000036: subject’s understanding and, if capable, the subject should sign and personally date the written informed
p.000036: consent.
p.000036: 4.8.13 Except as described in 4.8.14, a non-therapeutic trial (i.e. a trial in which there is no anticipated direct
p.000036: clinical benefit to the subject), should be conducted in subjects who personally give consent and who sign and date the
p.000036: written informed consent form.
p.000036: 4.8.14 Non-therapeutic trials may be conducted in subjects with consent of a legally acceptable
p.000036: representative provided the following conditions are fulfilled:
p.000036: (a) The objectives of the trial can not be met by means of a trial in subjects who can give informed consent
p.000036: personally.
p.000036: (b) The foreseeable risks to the subjects are low.
p.000036: (c) The negative impact on the subject’s well-being is minimized and low.
p.000036: (d) The trial is not prohibited by law.
p.000036: Such trials, unless an exception is justified, should be conducted in patients having a disease or
p.000036: condition for which the investigational product is intended. Subjects in these trials should be particularly closely
p.000036: monitored and should be withdrawn if they appear to be
p.000036:
p.000037: 37
p.000037:
p.000037: unduly distressed.
p.000037:
p.000037: 4.8.15 In emergency situations, when prior consent of the subject is not possible, the consent of the
p.000037: subject's legally acceptable representative, if present, should be requested. When prior consent of the
p.000037: subject is not possible, and the subject’s legally acceptable representative is not available, enrollment of the
p.000037: subject should require measures described in the protocol and/or elsewhere, with documented
p.000037: approval/favourable opinion by the IRB/IEC and PBSL approval, to protect the rights, safety and well-being
p.000037: of the subject and to ensure compliance with applicable regulatory requirements. The subject or the subject's
p.000037: legally acceptable representative should be informed about the trial as soon as possible and consent to continue and
p.000037: other consent as appropriate (see 4.8.10) should be requested.
p.000037: 4.9 Records and Reports
p.000037: 4.9.0 The investigator/institution should maintain adequate and accurate source documents and trial records that
p.000037: include all pertinent observations on each of the site’s trial subjects. Source data should be attributable,
p.000037: legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable,
p.000037: should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail).
...
p.000044: and in the trial population to
p.000044:
p.000045: 45
p.000045:
p.000045: be studied.
p.000045: 5.12.2 The sponsor should update the Investigator's Brochure as significant new information
p.000045: becomes available (see section 7. Investigator's Brochure of this guideline).
p.000045: 5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
p.000045: 5.13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000045: placebo) is characterized as appropriate to the stage of development of the product(s), is manufactured
p.000045: in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding. In addition,
p.000045: the labelling should comply with PBSL regulatory requirement(s).
p.000045: 5.13.2 The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage
p.000045: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices
p.000045: for product infusion, if any. The sponsor should inform all involved parties (e.g. monitors,
p.000045: investigators, pharmacists, storage managers) of these determinations.
p.000045: 5.13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during
p.000045: transport and storage.
p.000045: 5.13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits
p.000045: rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the
p.000045: blinding.
p.000045: 5.13.5 If significant formulation changes are made in the investigational or comparator product(s) during the course
p.000045: of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000045: dissolution rate, bioavailability) needed to assess whether these changes would significantly
p.000045: alter the pharmacokinetic profile of the product should be made available to PBSL prior to the use of the new
p.000045: formulation in clinical trials.
p.000045:
p.000045:
p.000045: 5.14 Supplying and Handling Investigational Product(s)
p.000045: 5.14.1 The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s).
p.000045: 5.14.2 The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor
p.000045: obtains PBSL approval.
p.000045: 5.14.3 The sponsor should ensure that written procedures include instructions that the
p.000045: investigator/institution should follow for the handling and storage of
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: investigational product(s) for the trial and documentation thereof. The procedures should address adequate and safe
p.000046: receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational
p.000046: product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the PBSL
p.000046: regulatory requirement(s)).
p.000046: 5.14.4 The sponsor should:
p.000046: (a) Ensure timely delivery of investigational product(s) to the investigator(s).
p.000046: (b) Maintain records that document shipment, receipt, disposition, return, and destruction of the
...
p.000071: X X
p.000071:
p.000071: (where required)
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: NO. Title of Document Purpose
p.000072: Located in File
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: 13. SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S)
p.000072:
p.000072:
p.000072: To document compliance with applicable labelling regulations and appropriateness of instructions provided to the
p.000072: subjects
p.000072: Investigator/I nstitution
p.000072: Sponsor
p.000072:
p.000072: X
p.000072:
p.000072:
p.000072: 14. INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
p.000072: (if not included in protocol or Investigator’s Brochure)
p.000072: 15. SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND
p.000072: TRIAL-RELATED MATERIALS
p.000072:
p.000072:
p.000072: 16. CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000072:
p.000072: 17. DECODING PROCEDURES FOR BLINDED TRIALS
p.000072: To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational
p.000072: products and trial-related materials
p.000072:
p.000072:
p.000072: To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related
p.000072: materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000072:
p.000072: To document identity, purity, and strength of investigational product(s) to be used in the trial
p.000072:
p.000072: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000072: the blind for the remaining subjects' treatment
p.000072: X X
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: X X
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072: X
p.000072:
p.000072:
p.000072:
p.000072: X X(third party if applicable)
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: NO. Title of Document Purpose
p.000073: Located in File
p.000073:
p.000073:
p.000073:
p.000073:
p.000073:
p.000073: 18. MASTER RANDOMISATION LIST
p.000073:
p.000073: 19. PRE-TRIAL MONITORING REPORT
p.000073:
p.000073:
p.000073: To document method for randomisation of trial population
p.000073:
p.000073: To document that the site is suitable for the trial (may be combined with 20)
p.000073: Investigator/I nstitution
p.000073: Sponsor
p.000073:
p.000073: X
p.000073: (third party if applicable
p.000073: X
p.000073:
p.000073:
p.000073: 20. TRIAL INITIATION MONITORING REPORT
p.000073:
p.000073:
p.000073: During the Clinical Conduct of the Trial
p.000073: To document that trial procedures X X were reviewed with the investigator
p.000073: and the investigator’s trial staff ( may be combined with 19)
p.000073: In addition to having on file the above documents the following should be added to the files during the trial as
p.000073: evidence that all new relevant information is documented as it becomes available.
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: conducted at the institution site within the constraints set forth by the PBSL or the national ethics committee,
p.000002: the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000002: Audit
p.000002: A systematic and independent examination of trial related activities and documents to determine whether the
p.000002: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported
p.000002: according to the protocol, sponsor's standard
p.000002:
p.000003: 3
p.000003:
p.000003: operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
p.000003: Audit Certificate
p.000003: A declaration of confirmation by the auditor that an audit has taken place.
p.000003: Audit Report
p.000003: A written evaluation by the sponsor's auditor of the results of the audit.
p.000003:
p.000003: Audit Trail
p.000003: Documentation that allows reconstruction of the course of events.
p.000003: Blinding/Masking
p.000003: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s).
p.000003: Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000003: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000003: assignment(s).
p.000003: Case Report Form (CRF)
p.000003: A printed, optical, or electronic document designed to record all of the protocol required information to be reported
p.000003: to the sponsor on each trial subject.
p.000003: Certificate of Analysis (COA)
p.000003: An authenticated document issued by an appropriate authority that certifies the quality and purity of pharmaceuticals,
p.000003: and animal and plant products.
p.000003: Certified Copy
p.000003: A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated
p.000003: signature or by generation through a validated process) to have the same information, including data that describe the
p.000003: context, content, and structure, as the original.
p.000003: Child/Minor A person who is below eighteen (18) years of age.
p.000003: Clinical Trial/Study
p.000003: Any investigation in human subjects intended to discover or verify the clinical, pharmacological
p.000003: and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an
p.000003: investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational
p.000003: product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are
p.000003: synonymous. It is has three phases:
p.000003: Phase I refers to the first introduction of a drug into humans. Normal volunteer subjects are usually studied to
p.000003: determine levels of drugs at which toxicity is observed. Such studies are followed by dose-ranging studies in patients
p.000003: for safety and, in some cases,early evidence of
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: effectiveness.
p.000004:
p.000004: Phase II investigation consists of controlled clinical trials designed to demonstrate effectiveness and
p.000004: relative safety. Normally, these are performed on a limited number of closely monitored patients.
p.000004: Phase III trials are performed after a reasonable probability of effectiveness of a drug has been established and are
p.000004: intended to gather additional evidence of effectiveness for specific indications and more precise definition of
p.000004: drug-related adverse effects. This phase includes both controlled and uncontrolled studies.
p.000004: Phase IV trials are conducted after the national drug registration authority has approved a drug for distribution or
p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
...
p.000017: medicines, non-pharmacological interventions including surgical procedures, medical devices and X-rays. However,
p.000017: this guideline is such that, in the absence of alternatives, the basic principles outlined in this document may be used
p.000017: to guide any research involving human participants, particularly research involving experimental study designs. This
p.000017: guideline has been guided by and based on the following documents:
p.000017: • ICH GCP (R2)
p.000017: • Declaration of Helsinki
p.000017: • International Guidelines for Ethical Review of Epidemiological Studies, Council for International Organisations of
p.000017: Medical Sciences (CIOMS), 1991
p.000017: • World Health Organisation, WHO Technical Report Series, No. 850, Guidelines for good clinical practice (GCP) for
p.000017: trials on pharmaceutical products, 1995
p.000017: In the event that these Guidelines differ from any of the above texts, these Guidelines will apply. The
p.000017: responsibility for deviation with any of the above documents lies with the authors of these Guidelines.
p.000017: 1.4 GUIDELINES AND LEGISLATION
p.000017:
p.000017: Regulations established in terms of the Pharmacy and Drugs Act of 2001 and the National Medicines Policy of 2012
p.000017: enforces this guideline. Compliance with this guideline is compulsory under the direction of the Pharmacy Board
p.000017: of Sierra Leone.
p.000017: 1.5 REGULATORY AUTHORITIES ROLES AND RESPONSIBILITIES
p.000017:
p.000017: This document outlines the roles and responsibilities of the various parties involved in controlling
p.000017: clinical trials in Sierra Leone. Specifically, these include:
p.000017: 1.5.1 The National Medicines Regulatory Authority (NMRA)/Pharmacy Board of Sierra Leone: All clinical trials of both
p.000017: non-registered medicinal substances and new indications of registered medicinal substances must be reviewed by the
p.000017: PBSL. The PBSL has a statutory obligation to ensure that the medicines available in the country fulfil the
p.000017: necessary requirements for safety, quality and efficacy. In the case of an ongoing trial where there are serious
p.000017: breaches of Good Clinical Practice (GCP), the PBSL can terminate the trial.
p.000017:
p.000018: 18
p.000018:
p.000018: 1.5.2 Research Ethics Committee: The main responsibility of Research Ethics Committee (REC) in Sierra Leone is
p.000018: to ensure the protection of, and respect the rights, safety and wellbeing of participants involved in a trial and to
p.000018: provide public assurance of that protection by reviewing, approving and providing comment on clinical trial protocols,
p.000018: the suitability of investigator(s), facilities, methods and procedures used to obtain informed consent. In the
p.000018: execution of these responsibilities, the committee should be guided by relevant Sierra Leone ethical guidelines,
p.000018: professional standards and codes of practice.
p.000018: 1.5.3 The Principal Investigator (PI): The principal investigator should be Sierra Leonean- based scientist who has
p.000018: a sole or joint responsibility for the design, conduct, delegation of trial responsibilities, analysis and reporting
p.000018: of the trial. The principal investigator is accountable to the sponsor and regulatory authorities as required by this
p.000018: Guideline. The PI should be knowledgeable and have an understanding of the drug, its toxicology and safety. In the case
p.000018: of a multi-centre trial there must be a local principal investigator (PI) attached to each site. It is unacceptable to
p.000018: have an "absentee" PI who is based in another country. See glossary for
p.000018: definitions of investigator/sub-investigator.
p.000018: 1.5.4 The Sponsor: An individual, company, institution, or organisation which takes responsibility for the initiation,
p.000018: management, and/or financing of a clinical trial.
p.000018: 1.5.7 The Monitor: The monitor is appointed by and reports to the sponsor. The monitor is responsible for
p.000018: overseeing the progress of a clinical trial and ensuring that it is conducted, recorded and reported in
p.000018: accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good
p.000018: Laboratory Practice (GLP), Good Pharmacy Practice (GPP), this guideline and other applicable legislation and
p.000018: regulations.
p.000018: 1.5.8 The Auditor: The auditors are independent individuals appointed by sponsors, local and other regulatory
p.000018: authority(ies) to conduct a systematic and in-depth examination of trial conduct and compliance with the
p.000018: protocol, SOPs, GCP, GLP, GPP and the applicable regulatory requirements. An audit is separate from routine
p.000018: monitoring or quality control functions.
p.000018: 1.5.9 The Inspector: The inspector is a qualified employee of local and international regulatory authority(ies)
p.000018: whose responsibility is to conduct announced or unannounced inspection visits at clinical trial
p.000018: sites/sponsors/CROs/bioequivalence facilities and research ethics committees as required/instructed by the
p.000018: regulatory authority(ies). Most inspectorate visits will be prearranged but some will not especially where
p.000018: there is suspected serious breaches of the GCP or malpractices.
p.000018:
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: 1.6 CLINICAL TRIAL APPROVAL IN SIERRA LEONE
p.000019:
p.000019: The following steps must be undertaken before a clinical trial can be conducted in Sierra Leone:
p.000019: • PBSL Approval: A sponsor/principal investigator (PI) must apply to the PBSL for approval to conduct a trial for a
p.000019: non-registered drug or a registered drug for new indications etc;
p.000019: • SLERSC Approval: All clinical trials to be conducted in Sierra Leone must apply for and receive ethical approval
p.000019: from the ethics committee
p.000019: 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000019: 3.1 RESPONSIBILITIES
p.000019: 3.1.1 An IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects. Special attention should be
p.000019: paid to trials that may include vulnerable subjects.
p.000019: 3.1.2 The IRB/IEC should obtain the following documents:
p.000019:
p.000019: trial protocol(s)/amendment(s), written informed consent form(s) and consent form updates that the investigator
p.000019: proposes for use in the trial, subject recruitment procedures (e.g. advertisements), written information to be
p.000019: provided to subjects, Investigator's Brochure (IB), available safety information, information about payments
...
p.000025: • Justify the involvement, as the study population, of institutionalised people with mental disabilities;
p.000025: • Ensure appropriate evaluation procedures for ascertaining participants' ability to give informed consent. If
p.000025: participants are deemed unable to understand and to make a choice, then an appropriate individual, able to consent on
p.000025: their behalf must be sought;
p.000025: • Ensure that consent is free from coercion and risk to participants; and
p.000025: • Ensure that only minimal risk is involved, and that the risk is outweighed by the anticipated benefits for the
p.000025: participants and by the importance of the knowledge that will emanate from the research.
p.000025: Persons with intellectual or mental impairment should not participate in research that might equally well be conducted
p.000025: with persons without those impairments.
p.000025: Consent to research must be obtained from:
p.000025: • the person with the intellectual or mental impairment, wherever he or she is competent to give
p.000025: informed consent;
p.000025: • the person's legal guardian where the person is deemed not competent to do so; or
p.000025: • an authority, organisation or person having that responsibility by law.
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: Consent cannot be given for participation in research that is contrary to the interests of the person with the
p.000026: intellectual or mental impairment.
p.000026: The intellectually or mentally impaired person's refusal to participate in research must always be
p.000026: respected.
p.000026:
p.000026: 3.4.4 Persons in Dependent Relationships or Comparable Situations: Persons whose proposed involvement in research
p.000026: arises from dependent or comparable relationships need additional attention and the research ethics committee must be
p.000026: satisfied that their consent is both adequately informed and voluntary.
p.000026: It is not possible to define such relationships exhaustively, but they include persons who are in junior or subordinate
p.000026: positions in hierarchically structured groups and may include relationships between:
p.000026: • older persons and their caregivers;
p.000026: • persons with chronic conditions or disabilities and their caregivers;
p.000026: • wards of State and guardians;
p.000026: • patients and health-care professionals;
p.000026: • students and teachers;
p.000026: • prisoners and prison authorities;
p.000026: • persons with life-threatening illnesses;
...
p.000069: protocol/amendment(s) and CRF
p.000069:
p.000069:
p.000069:
p.000069: 3. INFORMATION GIVEN TO TRIAL SUBJECT
p.000069:
p.000069: - INFORMED CONSENT FORM
p.000069: (including all applicable translations)
p.000069: - ANY OTHER WRITTEN INFORMATION
p.000069:
p.000069:
p.000069:
p.000069:
p.000069:
p.000069: - ADVERTISEMENT FOR SUBJECT RECRUITMENT
p.000069: (if used)
p.000069: X X
p.000069:
p.000069:
p.000069:
p.000069: To document the informed consent
p.000069:
p.000069: To document that subjects will be given appropriate written information (content and wording) to support their ability
p.000069: to give fully informed consent
p.000069:
p.000069: To document that recruitment measures are appropriate and not coercive
p.000069:
p.000069:
p.000069:
p.000069: 4. FINANCIAL ASPECTS OF THE TRIAL
p.000069: To document the financial X X agreement between the
p.000069: investigator/institution and the sponsor for the trial
p.000070: 70
p.000070:
p.000070:
p.000070:
p.000070: NO. Title of Document Purpose
p.000070: Located in File
p.000070:
p.000070: Investigator/I nstitution
p.000070: Sponsor
p.000070:
p.000070: 5. INSURANCE STATEMENT
p.000070: (where required)
p.000070:
p.000070: 6. SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:
p.000070: - investigator/institution and sponsor
p.000070:
p.000070: - investigator/institution and CRO
p.000070: -sponsor and CRO
p.000070: -investigator/institution and authority(ies) (where required)
p.000070: To document that compensation X X to subject(s) for trial-related
p.000070: injury will be available To document agreements
p.000070:
p.000070: X X
p.000070:
p.000070: X X
p.000070: (where required)
p.000070: X
p.000070:
p.000070: X X
p.000070:
p.000070: 7. DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000070: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000070: -Protocol and any amendments
p.000070: -CRF (if applicable)
p.000070: -Informed consent form(s)
p.000070: -Any other written information to be provided to the subject(s)
p.000070: - Advertisement for subject recruitment
p.000070: (if used)
p.000070: -Subject compensation (if any)
p.000070: - Any other documents given approval/ favourable opinion
p.000070: To document that the trial has X X been subject to IRB/IEC review
p.000070: and given approval/favourable opinion. To identify the version number and date of the document(s)
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: Investigator/I nstitution
p.000071: Sponsor
p.000071:
p.000071: 8. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION
p.000071:
p.000071: 9. PBSL
p.000071: AUTHORISATION/APPROVAL/
p.000071: NOTIFICATION OF PROTOCOL
p.000071: (where required)
...
p.000079: site, dispensed to subjects, returned by the subjects, and returned to sponsor
p.000079:
p.000079:
p.000079: 47. DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION
p.000079:
p.000079: 48. COMPLETED SUBJECT IDENTIFICATION CODE LIST
p.000079:
p.000079:
p.000079: 49. AUDIT CERTIFICATE
p.000079: (if available)
p.000079:
p.000079: 50. FINAL TRIAL CLOSE-OUT
p.000079: MONITORING REPORT
p.000079:
p.000079:
p.000079: 51. TREATMENT ALLOCATION AND
p.000079: DECODING DOCUMENTAT ION
p.000079: To document destruction of unused investigational products by sponsor or at site
p.000079:
p.000079: To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a
p.000079: confidential manner and for agreed upon time
p.000079:
p.000079: To document that audit was performed
p.000079:
p.000079: To document that all activities required for trial close-out are completed, and copies of essential documents are held
p.000079: in the appropriate files
p.000079:
p.000079: Returned to sponsor to document any decoding that may have occurred
p.000079: X (if X
p.000079: destroyed site)
p.000079:
p.000079:
p.000079: X
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: X
p.000079:
p.000079:
p.000079: X
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000079: X
p.000079:
p.000079:
p.000079:
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: NO. Title of Document Purpose Located
p.000080: in File
p.000080:
p.000080:
p.000080:
p.000080:
p.000080: 52. FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY
p.000080: AUTHORITY(IES)
p.000080:
p.000080:
p.000080:
p.000080: To document completion of the trial. See 3.5.3 of PBSL Guideline for Conducting Clinical Trial.
p.000080: Investigator/ Institution
p.000080: X
p.000080: Sponsor
p.000080:
p.000080: 8.4.8 CLINICAL STUDY REPORT
p.000080: To document results and interpretation of trial.See PBSL 3.5.of PBSL Guideline for Conducting Clinical Trial.
p.000080: X (if applicable) X
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000080:
p.000081: 81
p.000081:
p.000081: APPENDIX 3: DECLARATION OF HELSINKI
p.000081:
p.000081: Recommendations guiding physicians in biomedical research involving human subjects
p.000081: Introduction
p.000081:
p.000081: It is the mission of the physician to safeguard the health of the people. His or her knowledge and
p.000081: conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical
p.000081: Association binds the physician with the words “The health of my patient will be my first consideration” and the
p.000081: International Code of Medical Ethics declares that “A physician shall act only in the patient’s interest when providing
p.000081: medical care which might have the effect of weakening the physical and mental condition of the patient.”
p.000081: The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000019:
p.000019:
p.000020: 20
p.000020:
p.000020: 3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk
p.000020: to human subjects, but at least once per year.
p.000020: 3.1.5 The IRB/IEC may request more information than is outlined in paragraph 4.8.10 be given to subjects when,
p.000020: in the judgement of the IRB/IEC, the additional information would add meaningfully to the protection of
p.000020: the rights, safety and/or well-being of the subjects.
p.000020: 3.1.6 When a non-therapeutic trial is to be carried out with the consent of the subject’s legally acceptable
p.000020: representative (see 4.8.12, 4.8.14), the IRB/IEC should determine that the proposed protocol
p.000020: and/or other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory
p.000020: requirements for such trials.
p.000020: 3.1.7 Where the protocol indicates that prior consent of the trial subject or the subject’s legally acceptable
p.000020: representative is not possible (see 4.8.15), the IRB/IEC should determine that the proposed protocol and/or
p.000020: other document(s) adequately addresses relevant ethical concerns and meets applicable regulatory requirements for
p.000020: such trials (i.e. in emergency situations).
p.000020: 3.1.8 The IRB/IEC should review both the amount and method of payment to subjects to assure that neither presents
p.000020: problems of coercion or undue influence on the trial subjects. Payments to a subject should be prorated and not wholly
p.000020: contingent on completion of the trial by the subject.
p.000020: 3.1.9 The IRB/IEC should ensure that information regarding payment to subjects, including the methods,
p.000020: amounts, and schedule of payment to trial subjects, is set forth in the written informed consent form and any other
p.000020: written information to be provided to subjects. The way payment will be prorated should be specified.
p.000020: 3.2 COMPOSITION, FUNCTIONS AND OPERATIONS
p.000020: 3.2.1 The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and
p.000020: experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended
p.000020: that the IRB/IEC should include:
p.000020: (a) At least five members.
p.000020: (b) At least one member whose primary area of interest is in a nonscientific area.
p.000020: (c) At least one member who is independent of the institution/trial site.
p.000020: Only those IRB/IEC members who are independent of the investigator and the sponsor of the trial should
p.000020: vote/provide opinion on a trial-related matter.
p.000020: A list of IRB/IEC members and their qualifications should be maintained.
p.000020:
p.000021: 21
p.000021:
p.000021: 3.2.2 The IRB/IEC should perform its functions according to written operating procedures, should maintain written
p.000021: records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory
p.000021: requirement(s).
p.000021: 3.2.3 An IRB/IEC should make its decisions at announced meetings at which at least a quorum, as stipulated in its
...
General/Other / cultural difference
Searching for indicator culturally:
(return to top)
p.000016: termination can be recommended on ethical grounds.
p.000016: • The Pharmacy Board of Sierra Leone (PBSL): Whilst the PBSL is not an ethical review committee, it is
p.000016: responsible for reviewing the study design, and in so doing reviews all significant ethical questions. The PBSL does
p.000016: thorough scientific review on all applications for clinical trials to be conducted in Sierra Leone.
p.000016: 1.2.8 Informed Consent: Informed consent is an essential component of ethical research. Obtaining informed
p.000016: consent implies the provision of information to potential participants regarding the nature of the research
p.000016: procedure, scientific purpose and alternatives to study participation.
p.000016: Informed consent may be difficult to achieve, especially when engaging people from disadvantaged and vulnerable
p.000016: communities where literacy and education opportunities are inadequate and where there are language barriers. However,
p.000016: every effort must be carried out to achieve informed consent.
p.000016: Participants' comprehension is addressed by laying out this information in a clear and simple style. In Sierra Leone,
p.000016: this must be achieved via the use of culturally acceptable practices including the use of the participant's
p.000016: language of choice. The conditions under which the consent is granted must be free of coercion, undue
p.000016: influence or incentives. Treatment for a given condition, which might be an attribute of the clinical trial design,
p.000016: should not be denied by the refusal to participate. Withdrawal from the clinical trial at any time will not result in
p.000016: undue clinical penalties to the participant.
p.000016: 1.2.9 Safety Monitoring: Safety monitoring of participants during and for defined periods after a clinical trial is
p.000016: an ethical requirement. This involves the prevention, appropriate monitoring, prompt reporting and appropriate
p.000016: management of serious adverse events.
p.000016: 1.2.10 Multi-centre Studies: The number of multi-centred clinical trials being undertaken in Sierra Leone is
p.000016: expected to increase dramatically in the coming years. There is a need to ensure that designs of such studies are
p.000016: appropriate for the local setting and that particular modifications are made to the local study when required e.g.
p.000016: inclusion/exclusion criteria. Special attention should also be paid to the sampling strategy when reviewing
p.000016: multi- centred clinical trials.
p.000016: Furthermore, it is unacceptable for developed country participants to have better standards of care offered
p.000016: in the study when compared to Sierra Leone participants. When Sierra Leone is chosen for a clinical trial while the
p.000016: trial is not undertaken in the
p.000016:
p.000017: 17
p.000017:
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General/Other / participants in a control group
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p.000083: national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when
p.000083: the subject is a minor,permission from the responsible relative replaces that of the subject in accordance
p.000083: with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be
p.000083: obtained in addition to the consent of the minor's legal guardian.
p.000083: 12. The research protocol should always contain a statement of the ethical considerations involved and should indicate
p.000083: that the principles enunciated in the present Declaration are complied with.
p.000083: II. Medical research combined with clinical care (Clinical research)
p.000083: 1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if
p.000083: in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
p.000083: 2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages
p.000083: of the best current diagnostic and therapeutic methods.
p.000083: 3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best
p.000083: proven diagnostic and therapeutic method.
p.000083: 4. The refusal of the patient to participate in a study must never interfere with the physician-patient
p.000083: relationship.
p.000083: 5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal
p.000083: should be stated in the experimental protocol for transmission to the independent committee (I, 2).
p.000083: 6. The physician can combine medical research with professional care, the objective being the acquisition of new
p.000083: medical knowledge, only to the extent that medical research is justified by its potential diagnostic or
p.000083: therapeutic value for the patient.
p.000083: III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)
p.000084: 84
p.000084:
p.000084: 1. In the purely scientific application of medical research carried out on a human being, it is the duty of the
p.000084: physician to remain the protector of the life and health of that person on whom biomedical research is being carried
p.000084: out.
p.000084: 2. The subjects should be volunteers--either healthy persons or patients for whom the experimental designed
p.000084: is not related to the patient's illness.
p.000084: 3. The investigator or the investigating team should discontinue the research if in his/her or their judgement it may,
p.000084: if continued, be harmful to the individual.
p.000084: 4. In research on man, the interest of science and society should never take precedence over considerations related to
p.000084: the wellbeing of the subject.
p.000084:
p.000084:
p.000084:
p.000084:
p.000084:
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p.000004: marketing. These trials may include research designed to explore a specific pharmacological effect, to establish
p.000004: the incidence of adverse reactions, or to determine the effects of long-term administration of a drug. Phase IV
p.000004: trials may also be designed to evaluate a drug in a population not studied adequately in the pre-marketing phases (such
p.000004: as children or the elderly) or to establish a new clinical indication for a drug. Such research is to be distinguished
p.000004: from marketing research, sales promotion studies, and routine post-marketing surveillance for adverse drug
p.000004: reactions in that these categories ordinarily need not be reviewed by ethical review committees (see Guideline 2 of
p.000004: CIOMS International Ethical Guidelines for Biomedical research in human subjects ).
p.000004: Clinical Trial/Study Report
p.000004: A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human
p.000004: subjects, in which the clinical and statistical description, presentations, and analyses are fully
p.000004: integrated into a single report (see the ICH E3 Guideline for Structure and Content of Clinical Study Reports).
p.000004: Comparator (Product)
p.000004: An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
p.000004: Compliance (in relation to trials)
p.000004: Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the
p.000004: applicable regulatory requirements.
p.000004: Confidentiality
p.000004: Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a
p.000004: subject's identity.
p.000004: Contract
p.000004: A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on
p.000004: delegation and distribution of tasks and obligations and, if
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: appropriate, on financial matters. The protocol may serve as the basis of a contract.
p.000005: Coordinating Committee
p.000005: A committee that a sponsor may organize to coordinate the conduct of a multicentre trial.
p.000005: Coordinating Investigator
p.000005: An investigator assigned the responsibility for the coordination of investigators at different centres participating in
p.000005: a multicentre trial.
p.000005: Contract Research Organization (CRO)
p.000005: A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a
p.000005: sponsor's trial-related duties and functions.
p.000005: Direct Access
p.000005: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation
p.000005: of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors)
p.000005: with direct access should take all reasonable precautions within the constraints of the applicable regulatory
...
p.000006: consent is documented by means of a written, signed and dated informed consent form.
p.000006: Inspection
p.000006: The act by PBSL of conducting an official review of documents, facilities, records, and any other resources that are
p.000006: deemed by the Board to be related to the clinical trial and that may be located at the site of the trial, at the
p.000006: sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by
p.000006: the Board.
p.000006: Institution (medical)
p.000006: Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
p.000006:
p.000006:
p.000006: Institutional Review Board (IRB)
p.000006: An independent body constituted of medical, scientific, and non-scientific members,
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects
p.000007: involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial
p.000007: protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent
p.000007: of the trial subjects.
p.000007: Interim Clinical Trial/Study Report
p.000007: A report of intermediate results and their evaluation based on analyses performed during the course of a trial.
p.000007: Investigational Product
p.000007: A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a
p.000007: clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a
p.000007: way different from the approved form, or when used for an unapproved indication, or when used to gain further
p.000007: information about an approved use.
p.000007: Investigator
p.000007: A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of
p.000007: individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal
p.000007: investigator. See also Sub-investigator.
p.000007: Investigator / Institution
p.000007: An expression meaning "the investigator and/or institution, where required by the applicable regulatory
p.000007: requirements".
p.000007: Investigator's Brochure
p.000007: A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study
p.000007: of the investigational product(s) in human subjects (see section7. Investigator’s Brochure).
p.000007: Legally Acceptable Representative
p.000007: An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective
p.000007: subject, to the subject's participation in the clinical trial.
p.000007:
p.000007:
p.000007: Local Monitor A person appointed by the Sponsor or CRO to oversee the progress of a clinical trial and of ensuring that
p.000007: it is conducted, recorded and reported in accordance with the SOPs, GCP and the applicable regulatory requirements.
p.000007:
p.000007:
p.000007: Monitoring
p.000007: The act of overseeing the progress of a clinical trial either by PBSL or an independent monitor selected by the sponsor
p.000007: to ensure that it is conducted, recorded, and reported in
p.000007:
p.000008: 8
p.000008:
p.000008: accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the
p.000008: applicable regulatory requirement(s).
p.000008:
p.000008:
p.000008: Monitoring Report
p.000008: A written report from the monitor to the sponsor after each site visit and/or other trial-related
p.000008: communication according to the sponsor’s SOPs.
p.000008: Monitoring Plan
p.000008: A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial.
p.000008: Multicentre Trial
p.000008: A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more
p.000008: than one investigator.
p.000008: Nonclinical Study
p.000008: Biomedical studies not performed on human subjects.
p.000008: Opinion (in relation to Independent Ethics Committee)
p.000008: The judgement and/or the advice provided by an Independent Ethics Committee (IEC).
p.000008: Original Medical Record
p.000008: See Source Documents.
p.000008: PBSL means Pharmacy Board of Sierra Leone
p.000008: Placebo A medication with no active ingredients or a procedure without any medical benefit.
p.000008: Principal Investigator / Investigator The person responsible for the conduct of the clinical trial at the clinical
p.000008: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000008: located.
p.000008: Protocol
p.000008: A document that describes the objective(s), design, methodology, statistical considerations,
p.000008: and organization of a trial. The protocol usually also gives the background and rationale for the trial, but
p.000008: these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term
p.000008: protocol refers to protocol and protocol amendments.
p.000008:
p.000008:
p.000008: Protocol Amendment
p.000008: A written description of a change(s) to or formal clarification of a protocol.
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: Quality Assurance (QA)
p.000009: All those planned and systematic actions that are established to ensure that the trial is performed and
p.000009: the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the
p.000009: applicable regulatory requirement(s).
p.000009: Quality Control (QC)
p.000009: The operational techniques and activities undertaken within the quality assurance system to verify that the
p.000009: requirements for quality of the trial-related activities have been fulfilled.
p.000009: Randomization
p.000009: The process of assigning trial subjects to treatment or control groups using an element of chance to determine the
p.000009: assignments in order to reduce bias.
p.000009: Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)
...
p.000044: regulatory requirement(s).
p.000044: 5.9 Financing
p.000044: The financial aspects of the trial should be documented in an agreement between the sponsor and the
p.000044: investigator/institution.
p.000044: 5.10 Notification/Submission to PBSL
p.000044: Before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator, should submit
p.000044: any required application(s) to PBSL for review and PBSL approval before commencement of the trial(s). Any
p.000044: notification/submission should be dated and contain sufficient information to identify the protocol.
p.000044: 5.11 Confirmation of Review by IRB/IEC
p.000044: 5.11.1 The sponsor should obtain from the investigator/institution:
p.000044: (a) The name and address of the investigator's/institution’s IRB/IEC.
p.000044: (b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the
p.000044: applicable laws and regulations.
p.000044:
p.000044:
p.000044: 5.12 Information on Investigational Product(s)
p.000044: 5.12.1 When planning trials, the sponsor should ensure that sufficient safety and efficacy data from nonclinical
p.000044: studies and/or clinical trials are available to support human exposure by the route, at the dosages, for the duration,
p.000044: and in the trial population to
p.000044:
p.000045: 45
p.000045:
p.000045: be studied.
p.000045: 5.12.2 The sponsor should update the Investigator's Brochure as significant new information
p.000045: becomes available (see section 7. Investigator's Brochure of this guideline).
p.000045: 5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
p.000045: 5.13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and
p.000045: placebo) is characterized as appropriate to the stage of development of the product(s), is manufactured
p.000045: in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding. In addition,
p.000045: the labelling should comply with PBSL regulatory requirement(s).
p.000045: 5.13.2 The sponsor should determine, for the investigational product(s), acceptable storage temperatures, storage
p.000045: conditions (e.g. protection from light), storage times, reconstitution fluids and procedures, and devices
p.000045: for product infusion, if any. The sponsor should inform all involved parties (e.g. monitors,
p.000045: investigators, pharmacists, storage managers) of these determinations.
p.000045: 5.13.3 The investigational product(s) should be packaged to prevent contamination and unacceptable deterioration during
p.000045: transport and storage.
p.000045: 5.13.4 In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits
p.000045: rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the
p.000045: blinding.
p.000045: 5.13.5 If significant formulation changes are made in the investigational or comparator product(s) during the course
p.000045: of clinical development, the results of any additional studies of the formulated product(s) (e.g. stability,
p.000045: dissolution rate, bioavailability) needed to assess whether these changes would significantly
p.000045: alter the pharmacokinetic profile of the product should be made available to PBSL prior to the use of the new
p.000045: formulation in clinical trials.
p.000045:
p.000045:
p.000045: 5.14 Supplying and Handling Investigational Product(s)
...
p.000054: responsible for all trial-site related medical (or dental) decisions (if other than investigator).
p.000054: 6.1.7 Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical
p.000054: department(s) and/or institutions involved in the trial.
p.000054: 6.2 Background Information
p.000054: 6.2.1 Name and description of the investigational product(s).
p.000054: 6.2.2 A summary of findings from nonclinical studies that potentially have clinical
p.000054:
p.000055: 55
p.000055:
p.000055: significance and from clinical trials that are relevant to the trial.
p.000055: 6.2.3 Summary of the known and potential risks and benefits, if any, to human subjects.
p.000055: 6.2.4 Description of and justification for the route of administration, dosage, dosage regimen, and
p.000055: treatment period(s).
p.000055: 6.2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and PBSL regulatory
p.000055: requirement(s).
p.000055: 6.2.6 Description of the population to be studied.
p.000055: 6.2.7 References to literature and data that are relevant to the trial, and that provide background for
p.000055: the trial.
p.000055: 6.3 Trial Objectives and Purpose
p.000055: A detailed description of the objectives and the purpose of the trial.
p.000055:
p.000055:
p.000055:
p.000055: 6.4 Trial Design
p.000055: The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the
p.000055: trial design. A description of the trial design, should include:
p.000055: 6.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the
p.000055: trial.
p.000055: 6.4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled,
p.000055: parallel design) and a schematic diagram of trial design, procedures and stages.
p.000055: 6.4.3 A description of the measures taken to minimize/avoid bias, including:
p.000055: (a) Randomization.
p.000055: (b) Blinding.
p.000055: 6.4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000055: product(s). Also include a description of the dosage form, packaging, and labelling of the
p.000055: investigational product(s).
p.000055: 6.4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial
p.000055: periods, including follow-up, if any.
p.000055: 6.4.6 A description of the "stopping rules" or "discontinuation criteria" for individual subjects, parts of
p.000055: trial and entire trial.
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: 6.4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.
p.000056: 6.4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes.
p.000056: 6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or
p.000056: electronic record of data), and to be considered to be source data.
p.000056: 6.5 Selection and Withdrawal of Subjects
p.000056: 6.5.1 Subject inclusion criteria.
p.000056: 6.5.2 Subject exclusion criteria.
p.000056: 6.5.3 Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures
p.000056: specifying:
p.000056: (a) When and how to withdraw subjects from the trial/ investigational product treatment.
p.000056: (b) The type and timing of the data to be collected for withdrawn subjects.
p.000056: (c) Whether and how subjects are to be replaced.
p.000056: (d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment.
p.000056: 6.6 Treatment of Subjects
p.000056: 6.6.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing
p.000056: schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up
p.000056: period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial.
p.000056: 6.6.2 Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or
p.000056: during the trial.
p.000056: 6.6.3 Procedures for monitoring subject compliance.
p.000056:
p.000056:
p.000056: 6.7 Assessment of Efficacy
p.000056: 6.7.1 Specification of the efficacy parameters.
p.000056: 6.7.2 Methods and timing for assessing, recording, and analysing of efficacy parameters.
p.000056: 6.8 Assessment of Safety
p.000056: 6.8.1 Specification of safety parameters.
...
Orphaned Trigger Words
p.000038: investigator/institution should promptly inform the trial subjects, should assure appropriate therapy and follow-up for
p.000038: the subjects, and also inform PBSL. In addition:
p.000038: 4.12.1 If the investigator terminates or suspends a trial without prior agreement of the sponsor, the
p.000038: investigator should inform the institution where applicable, and the investigator/institution should promptly inform
p.000038: the sponsor and PBSL and should provide the sponsor and PBSL a detailed written explanation of the termination or
p.000038: suspension.
p.000038:
p.000039: 39
p.000039:
p.000039: 4.12.2 If the sponsor terminates or suspends a trial (see sub-section 5.21), the investigator should promptly inform
p.000039: the institution where applicable and the investigator/institution should promptly inform PBSL and provide PBSL
p.000039: a detailed written explanation of the termination or suspension.
p.000039: 4.12.3 If the PBSL terminates or suspends its approval of a trial (see subsections 3.1.2 and 3.3.9), the investigator
p.000039: should inform the institution where applicable and the investigator/institution should promptly notify the
p.000039: sponsor and provide the sponsor with a detailed written explanation of the termination or suspension.
p.000039: 4.13 Final Report(s) by Investigator
p.000039: Upon completion of the trial, the investigator s should provide the PBSL with a summary of the trial’s outcome. See
p.000039: PBSL guidelines for conducting clinical trial for format.
p.000039: 5. SPONSOR
p.000039: 5.0 Quality Management
p.000039: The sponsor should implement a system to manage quality throughout all stages of the trial process. Sponsors should
p.000039: focus on trial activities essential to ensuring human subject protection and the reliability of trial results.
p.000039: Quality management includes the design of efficient clinical trial protocols and tools and procedures for data
p.000039: collection and processing, as well as the collection of information that is essential to decision making. The methods
p.000039: used to assure and control the quality of the trial should be proportionate to the risks inherent in the
p.000039: trial and the importance of the information collected. The sponsor should ensure that all aspects of the trial are
p.000039: operationally feasible and should avoid unnecessary complexity, procedures, and data collection. Protocols, case
p.000039: report forms, and other operational documents should be clear, concise, and consistent. The quality management
p.000039: system should use a risk-based approach as described below.
p.000039: 5.0.1 Critical Process and Data Identification
p.000039: During protocol development, the sponsor should identify those processes and data that are critical to ensure human
p.000039: subject protection and the reliability of trial results.
p.000039: 5.0.2 Risk Identification
p.000039: The sponsor should identify risks to critical trial processes and data. Risks should be considered at
p.000039: both the system level (e.g., standard operating procedures, computerized systems, personnel) and clinical
p.000039: trial level (e.g., trial design, data collection, informed consent process).
p.000039: 5.0.3 Risk Evaluation
p.000039: The sponsor should evaluate the identified risks, against existing risk controls by considering:
p.000039:
p.000039:
p.000040: 40
p.000040:
p.000040: (a) The likelihood of errors occurring.
p.000040: (b) The extent to which such errors would be detectable.
p.000040: (c) The impact of such errors on human subject protection and reliability of trial results.
p.000040: 5.0.4 Risk Control
p.000040: The sponsor should decide which risks to reduce and/or which risks to accept. The approach used to
p.000040: reduce risk to an acceptable level should be proportionate to the significance of the risk. Risk reduction
p.000040: activities may be incorporated in protocol design and implementation, monitoring plans, agreements between
p.000040: parties defining roles and responsibilities, systematic safeguards to ensure adherence to standard
p.000040: operating procedures, and training in processes and procedures. Predefined quality tolerance limits should be
p.000040: established, taking into consideration the medical and statistical characteristics of the variables as well as the
p.000040: statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial
p.000040: results. Detection of deviations from the predefined quality tolerance limits should trigger an evaluation to determine
p.000040: if action is needed.
p.000040: 5.0.5 Risk Communication
p.000040: The sponsor should document quality management activities. The sponsor should communicate quality
p.000040: management activities to those who are involved in or affected by such activities, to facilitate risk review and
p.000040: continual improvement during clinical trial execution.
p.000040: 5.0.6 Risk Review
p.000040: The sponsor should periodically review risk control measures to ascertain whether the implemented quality
p.000040: management activities remain effective and relevant, taking into account emerging knowledge and experience.
p.000040: 5.0.7 Risk Reporting The sponsor should describe the quality management approach implemented in the trial
...
p.000047: GCP, and with the applicable regulatory requirement(s).
p.000047: 5.18.2 Selection and Qualifications of Monitors
p.000047: (a) Monitors should be appointed by the sponsor.
p.000047: (b) Monitors should be appropriately trained, and should have the scientific and/or clinical knowledge needed to
p.000047: monitor the trial adequately. A monitor’s qualifications should be documented.
p.000047: (c) Monitors should be thoroughly familiar with the investigational product(s), the protocol, written informed consent
p.000047: form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the PBSL regulatory
p.000047: requirement(s).
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: 5.18.3 Extent and Nature of Monitoring
p.000048: The sponsor should ensure that the trials are adequately monitored. The sponsor should determine the
p.000048: appropriate extent and nature of monitoring. The determination of the extent and nature of
p.000048: monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size,
p.000048: and endpoints of the trial. In general, there is a need for on-site monitoring, before, during, and after the trial;
p.000048: however, in exceptional circumstances the sponsor may determine that central monitoring in conjunction with
p.000048: procedures such as investigators’ training and meetings, and extensive written guidance can assure
p.000048: appropriate conduct of the trial in accordance with GCP. Statistically controlled sampling may be an acceptable method
p.000048: for selecting the data to be verified.
p.000048: The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.
p.000048: The flexibility in the extent and nature of monitoring described in this section is intended to permit varied
p.000048: approaches that improve the effectiveness and efficiency of monitoring. The sponsor may choose on-site
p.000048: monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring.
p.000048: The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).
p.000048: On-site monitoring is performed at the sites at which the clinical trial is being conducted. Centralized
p.000048: monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by
p.000048: appropriately qualified and trained persons (e.g., data managers, biostatisticians).
p.000048: Centralized monitoring processes provide additional monitoring capabilities that can complement and reduce the extent
p.000048: and/or frequency of on-site monitoring and help distinguish between reliable data and potentially unreliable data.
p.000048: Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:
p.000048: (a) identify missing data, inconsistent data, data outliers, unexpected lack of variability and protocol
p.000048: deviations.
p.000048: (b) examine data trends such as the range, consistency, and variability of data within and across sites.
p.000048: (c) evaluate for systematic or significant errors in data collection and reporting at a site or across sites; or
p.000048: potential data manipulation or data integrity problems. (d) analyze site characteristics and performance metrics.
p.000048: (e) select sites and/or processes for targeted on-site monitoring.
p.000048:
p.000048:
p.000048:
p.000049: 49
p.000049:
p.000049:
p.000049: 5.18.4 Monitor's Responsibilities
p.000049: The monitor(s) in accordance with the sponsor’s requirements should ensure that the trial is conducted and documented
p.000049: properly by carrying out the following activities when relevant and necessary to the trial and the trial site:
p.000049: (a) Acting as the main line of communication between the sponsor and the investigator.
p.000049: (b) Verifying that the investigator has adequate qualifications and resources (see 4.1, 4.2, 5.6) and remain adequate
p.000049: throughout the trial period, that facilities, including laboratories, equipment, and staff, are adequate to
p.000049: safely and properly conduct the trial and remain adequate throughout the trial period.
p.000049: (c) Verifying, for the investigational product(s):
p.000049: (i) That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.
p.000049: (ii) That the investigational product(s) are supplied only to subjects who are eligible to receive it and at the
p.000049: protocol specified dose(s).
p.000049: (iii) That subjects are provided with necessary instruction on properly using, handling, storing, and returning the
p.000049: investigational product(s).
p.000049: (iv) That the receipt, use, and return of the investigational product(s) at the trial sites are controlled and
p.000049: documented adequately.
p.000049: (v) That the disposition of unused investigational product(s) at the trial sites complies with applicable regulatory
p.000049: requirement(s) and is in accordance with the sponsor.
p.000049: (d) Verifying that the investigator follows the approved protocol and all approved amendment(s), if any.
p.000049: (e) Verifying that written informed consent was obtained before each subject's participation in the trial.
p.000049: (f) Ensuring that the investigator receives the current Investigator's Brochure, all documents, and all trial supplies
p.000049: needed to conduct the trial properly and to comply with the PBSL regulatory requirement(s).
p.000049: (g) Ensuring that the investigator and the investigator's trial staff are adequately informed about the trial.
p.000049: (h) Verifying that the investigator and the investigator's trial staff are performing the specified trial functions,
p.000049: in accordance with the protocol and any other written agreement between the sponsor and the
p.000049: investigator/institution, and
p.000049:
p.000050: 50
p.000050:
p.000050: have not delegated these functions to unauthorized individuals.
p.000050: (i) Verifying that the investigator is enrolling only eligible subjects.
p.000050: (j) Reporting the subject recruitment rate.
p.000050: (k) Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained.
p.000050: (l) Verifying that the investigator provides all the required reports, notifications, applications, and
p.000050: submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the
p.000050: trial.
p.000050: (m) Checking the accuracy and completeness of the CRF entries, source documents and other trial-related records
p.000050: against each other. The monitor specifically should verify that:
p.000050: (i) The data required by the protocol are reported accurately on the CRFs and are consistent with the source documents.
p.000050: (ii) Any dose and/or therapy modifications are well documented for each of the trial subjects.
p.000050: (iii) Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the
p.000050: protocol on the CRFs.
...
p.000050: taking appropriate action designed to prevent recurrence of the detected deviations.
p.000050:
p.000050:
p.000051: 51
p.000051:
p.000051: 5.18.5 Monitoring Procedures
p.000051: The monitor(s) should follow the sponsor’s established written SOPs as well as those procedures that are
p.000051: specified by the sponsor for monitoring a specific trial.
p.000051: 5.18.6 Monitoring Report
p.000051: (a) The monitor should submit a written report to the sponsor after each trial-site visit or trial-related
p.000051: communication.
p.000051: (b) Reports should include the date, site, name of the monitor, and name of the investigator or other individual(s)
p.000051: contacted.
p.000051: (c) Reports should include a summary of what the monitor reviewed and the monitor's statements concerning
p.000051: the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken
p.000051: and/or actions recommended to secure compliance.
p.000051: (d) The review and follow-up of the monitoring report with the sponsor should be documented by the sponsor’s designated
p.000051: representative.
p.000051: (e) Reports of on-site and/or centralized monitoring should be provided to the sponsor (including
p.000051: appropriate management and staff responsible for trial and site oversight) in a timely manner for review and
p.000051: follow up. Results of monitoring activities should be documented in sufficient detail to allow verification
p.000051: of compliance with the monitoring plan. Reporting of centralized monitoring activities should be regular and may
p.000051: be independent from site visits.
p.000051: 5.18.7 Monitoring Plan
p.000051: The sponsor should develop a monitoring plan that is tailored to the specific human subject protection and data
p.000051: integrity risks of the trial. The plan should describe the monitoring strategy, the monitoring responsibilities
p.000051: of all the parties involved, the various monitoring methods to be used, and the rationale for their use. The plan
p.000051: should also emphasize the monitoring of critical data and processes. Particular attention should be given to those
p.000051: aspects that are not routine clinical practice and that require additional training. The monitoring
p.000051: plan should reference the applicable policies and procedures.
p.000051: 5.19 Audit
p.000051: If or when sponsors perform audits, as part of implementing quality assurance, they should consider:
p.000051: 5.19.1 Purpose
p.000051: The purpose of a sponsor's audit, which is independent of and separate from routine monitoring or quality control
p.000051: functions, should be to evaluate trial conduct and
p.000051:
p.000052: 52
p.000052:
p.000052: compliance with the protocol, SOPs, GCP, and PBSL regulatory requirements.
p.000052: 5.19.2 Selection and Qualification of Auditors
p.000052: (a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct
p.000052: audits.
p.000052: (b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits
p.000052: properly. An auditor’s qualifications should be documented.
p.000052: 5.19.3 Auditing Procedures
p.000052: (a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance
p.000052: with the sponsor's written procedures on what to audit, how to audit, the frequency of audits, and the form and
p.000052: content of audit reports.
p.000052: (b) The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial to
p.000052: submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the
p.000052: level of risks to the trial subjects, and any identified problem(s).
p.000052: (c) The observations and findings of the auditor(s) should be documented.
p.000052: (d) When required by applicable law or regulation, the sponsor should provide an audit certificate.
p.000052: 5.20 Noncompliance
p.000052: 5.20.1 Noncompliance with the protocol, SOPs, GCP and PBSL regulatory requirement(s) by an investigator/institution, or
p.000052: by member(s) of the sponsor's staff should lead to prompt action by the sponsor to secure compliance. If
p.000052: noncompliance that significantly affects or has the potential to significantly affect human subject
p.000052: protection or reliability of trial results is discovered, the sponsor should perform a root cause analysis and
p.000052: implement appropriate corrective and preventive actions.
p.000052: 5.20.2 If the monitoring and/or auditing identifies serious and/or persistent noncompliance on the part of an
p.000052: investigator/institution, the sponsor should terminate the investigator's/institution’s participation
p.000052: in the trial. When an investigator's/institution’s participation is terminated because of
p.000052: noncompliance, the sponsor should notify PBSL promptly.
p.000052: 5.21 Premature Termination or Suspension of a Trial
p.000052: If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions,
p.000052: and PBSL of the termination or suspension and the reason(s) for the termination or suspension. The IEC should also be
p.000052: informed promptly and provided the
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: reason(s) for the termination or suspension by the sponsor or by the investigator/institution, as specified by the PBSL
p.000053: regulatory requirement(s).
p.000053: 5.22 Clinical Trial/Study Reports
p.000053: Whether the trial is completed or prematurely terminated, the sponsor should ensure that the clinical trial reports are
p.000053: prepared and provided to PBSL as required by PBSL regulatory requirement(s). The sponsor should also ensure that the
p.000053: clinical trial reports in marketing applications meet the standards of the ICH Guideline for Structure and Content of
p.000053: Clinical Study Reports. (NOTE: The ICH Guideline for Structure and Content of Clinical Study Reports specifies that
p.000053: abbreviated study reports may be acceptable in certain cases.)
p.000053: 5.23 Multicentre Trials
p.000053: For multicentre trials, the sponsor should ensure that:
p.000053: 5.23.1 All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor and
p.000053: approvals of PBSL and IEC.
p.000053: 5.23.2 The CRFs are designed to capture the required data at all multicentre trial sites. For those investigators who
p.000053: are collecting additional data, supplemental CRFs should also be provided that are designed to capture the additional
p.000053: data.
p.000053: 5.23.3 The responsibilities of coordinating investigator(s) and the other participating investigators are
p.000053: documented prior to the start of the trial.
p.000053: 5.23.4 All investigators are given instructions on following the protocol, on complying with a uniform set of
p.000053: standards for the assessment of clinical and laboratory findings, and on completing the CRFs.
p.000053: 5.23.5 Communication between investigators is facilitated.
p.000053:
p.000053: 5.24. The external sponsor should strengthen local capacity for ethical, scientific review, biomedical research and
p.000053: provide healthcare services as described in guidelines 20, 21 of the International Ethical Guidelines for Biomedical
p.000053: Research involving Human Subjects (CIOMS 2002).
p.000053: Sponsors and investigators have an ethical obligation to ensure that biomedical research projects contribute
p.000053: effectively to national or local capacity building. Capacity building may include, but is not limited to, the following
p.000053: activities:
p.000053: 5.24.1 Establishing and strengthening independent and competent ethical review processes/committees.
p.000053: 5.24.2 Developing technologies appropriate to health-care and biomedical research.
p.000053: 5.24.3 Training of research and health-care staff.
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: 5.24.4 Educating the community from which research subjects will be drawn.
p.000054:
p.000054: 5.25. External sponsors are ethically obliged to ensure the availability of:
p.000054:
p.000054: 5.25.1. health-care services that are essential to the safe conduct of the research
p.000054: 5.25.2. treatment of subjects who suffer injury as a consequence of research intervention; and
p.000054: 5.25.3. services that are a necessary part of the commitment of a sponsor to make a beneficial intervention or
p.000054: product developed as a result of the research reasonably available to the population or community concerned.
p.000054: 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
p.000054: The contents of a trial protocol should generally include the following topics. However, site specific information may
p.000054: be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed
p.000054: below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.
p.000054:
p.000054:
p.000054: 6.1 General Information
p.000054: 6.1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s)
p.000054: and date(s).
p.000054: 6.1.2 Name and address of the sponsor and monitor (if other than the sponsor).
p.000054: 6.1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for
p.000054: the sponsor.
p.000054: 6.1.4 Name, title, address, and telephone number(s) of the sponsor's medical expert (or dentist when appropriate) for
p.000054: the trial.
...
p.000059: that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit
p.000059: assessment of the appropriateness of the proposed trial. For this reason, a medically qualified person should
p.000059: generally participate in the editing of an IB, but the contents of the IB should be approved by the disciplines that
p.000059: generated the described data.
p.000059: This guideline delineates the minimum information that should be included in an IB and provides suggestions for its
p.000059: layout. It is expected that the type and extent of information available will vary with the stage of development
p.000059: of the investigational product. If the investigational product is marketed and its pharmacology is widely
p.000059: understood by medical practitioners, an extensive IB may not be necessary. PBSL may permit a basic product information
p.000059: brochure, package leaflet, or labelling may be an appropriate alternative, provided that it includes current,
p.000059: comprehensive, and detailed information on all aspects of the investigational product that might be of importance to
p.000059: the investigator. If a marketed product is being studied for a new use (i.e., a new indication), an IB specific to that
p.000059: new use should be prepared. The IB should be reviewed at least annually and revised as necessary in compliance with
p.000059: a sponsor's written procedures. More frequent revision may be appropriate depending on the stage of
p.000059: development and the generation of relevant new information. However, in accordance with Good Clinical
p.000059: Practice, relevant new information may be so important that it should be communicated to the investigators, to the
p.000059: Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) and to PBSL before it is included in a revised
p.000059: IB.
p.000059:
p.000059:
p.000059: 7.2 General Considerations
p.000059: The IB should include:
p.000059: 7.2.1 Title Page
p.000059: This should provide the sponsor's name, the identity of each investigational product (i.e., research number,
p.000059: chemical or approved generic name, and trade name(s) where legally permissible and desired by the sponsor), and
p.000059: the release date. It is also suggested that an edition number, and a reference to the number and date of the edition it
p.000059: supersedes, be provided. An example is given in Appendix 1.
p.000059: 7.2.2 Confidentiality Statement
p.000059: The sponsor may wish to include a statement instructing the investigator/recipients to treat the IB as a confidential
p.000059: document for the sole information and use of the investigator's team and the IRB/IEC.
p.000059: 7.3 Contents of the Investigator’s Brochure
p.000059: The IB should contain the following sections, each with literature references where
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: appropriate:
p.000060: 7.3.1 Table of Contents
p.000060: An example of the Table of Contents is given in Appendix 2
p.000060: 7.3.2 Summary
p.000060: A brief summary (preferably not exceeding two pages) should be given, highlighting the significant
p.000060: physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical
p.000060: information available that is relevant to the stage of clinical development of the investigational product.
p.000060: 7.3.3 Introduction
p.000060: A brief introductory statement should be provided that contains the chemical name (and generic and trade name(s) when
p.000060: approved) of the investigational product(s), all active ingredients, the investigational product (s) pharmacological
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| alcoholism | alcoholism |
| armed forces | Soldier |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| coerce | Presence of Coercion |
| cognitive | Cognitive Impairment |
| control group | participants in a control group |
| criminal | criminal |
| culturally | cultural difference |
| dependency | Drug Dependence |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| elderly | Elderly |
| embryo | embryo |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| gender | gender |
| hazard | Natural Hazards |
| homeless | Homeless Persons |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incapable | Mentally Incapacitated |
| incapacity | Incapacitated |
| incarcerated | Incarcerated |
| indigenous | Indigenous |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| liberty | Incarcerated |
| literacy | Literacy |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| minority | Racial Minority |
| nomads | nomad |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| party | political affiliation |
| placebo | participants in a control group |
| political | political affiliation |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| religious | Religion |
| sick | Physically Ill |
| single | Marital Status |
| substance | Drug Usage |
| terminal | Terminally Ill |
| unconscious | Unconscious People |
| undue influence | Undue Influence |
| unemployed | Unemployment |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| cognitive | ['impaired', 'impairment'] |
| control group | ['placebo'] |
| disability | ['mentally'] |
| drug | ['influence', 'substance'] |
| fetus | ['foetus', 'foetuses'] |
| foetus | ['fetus', 'foetuses'] |
| foetuses | ['fetus', 'foetus'] |
| impaired | ['cognitive', 'impairment'] |
| impairment | ['cognitive', 'impaired'] |
| incarcerated | ['liberty', 'prison'] |
| influence | ['drug', 'substance'] |
| liberty | ['incarcerated', 'prison'] |
| mentally | ['disability'] |
| party | ['political'] |
| placebo | ['controlXgroup'] |
| political | ['party'] |
| prison | ['incarcerated', 'liberty'] |
| substance | ['drug', 'influence'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input