79C3C34C52B45572883A05D425EB0F82
Guidelines for Good Clinical Practice
http://www.fdaghana.gov.gh/images/stories/pdfs/downloads/drugs%20guidelines/GUIDELINES%20FOR%20GOOD%20CLINICAL%20PRACTICE%20IN%20GHANA.pdf
http://leaux.net/URLS/ConvertAPI Text Files/ECA8BDE91374E22A178631409438C386.en.txt
Examining the file media/Synopses/ECA8BDE91374E22A178631409438C386.html:
This file was generated: 2020-12-01 09:14:50
| 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.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
p.000047: protocol, investigators brochure, patient consent forms, insurance for participants, current CV’s for
p.000047: investigators and literature detailing rationale for the study and any other documents that the IRB/ICE
p.000047: may need to fulfill its responsibilities.
p.000047: 3.1.5. The Ethics Committee shall consider the following:
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
p.000047: 3.1.5.2. The suitability of the protocol in relation to the objectives of the study. Its scientific efficiency
p.000047: i.e. the potential for reaching sound conclusions with the smallest possible exposure of subjects,
...
Political / political affiliation
Searching for indicator party:
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p.000047: investigational product(s)
p.000047: and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document identity, purity, and strength of X investigational
p.000047: product(s) to be used in the trial
p.000047: Page 40 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000047:
p.000047:
p.000047: 17.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 18.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 19.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 20.
p.000047: DECODING PROCEDURES FOR BLINDED TRIALS
p.000047:
p.000047:
p.000047: MASTER RANDOMISATION LIST
p.000047:
p.000047: PRE-TRIAL MONITORING REPORT
p.000047:
p.000047:
p.000047: TRIAL INITIATION MONITORING REPORT
p.000047: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000047: the blind for the remaining subjects' treatment
p.000047:
p.000047: To document method for randomization of trial population
p.000047:
p.000047:
p.000047: To document that the site is suitable for the trial (may be combined with 20)
p.000047:
p.000047:
p.000047: To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be
p.000047: combined with 19)
p.000047: X X
p.000047: (a third party if applicable)
p.000047:
p.000047:
p.000047: X
p.000047: (a third party if applicable)
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: 3.0. During the Clinical Conduct of the Trial
p.000047: In addition to having on file the above documents, the following should be added to the files during the trial as
p.000047: evidence that all new relevant information is documented as it becomes available
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of
p.000047: Investigator /Sponsor Sp
p.000047: or
p.000047:
p.000047:
p.000047: 21.
p.000047: INVESTIGATOR’S BROCHURE UPDATES
p.000047: To document that investigator is informed in a X X timely manner of
p.000047: relevant information as it
p.000047: becomes available
p.000047:
p.000047:
p.000047: Page 41 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 22.
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p.000047:
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p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 23.
p.000047: ANY REVISION TO:
p.000047: - Protocol/amendment(s) and CRF
p.000047: - Informed consent form any other written
p.000047: - Information provided to subjects
p.000047: - Advertisement for subject recruitment
p.000047: (if used)
p.000047:
p.000047:
p.000047: DATED, DOCUMENTED APPROVAL/ FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000047: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000047: -Protocol amendment(s)
p.000047: -Revision(s) of:
p.000047: - informed consent form
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000004:
p.000004:
p.000004: Document No. : FDA/SMC/CTD/GL-GCP/2013/02
p.000004: Date of First Adoption : 1st February, 2013
p.000004: Date of Issue : 1st March, 2013
p.000004: Version No. 01
p.000004:
p.000004: FDA/SMC/CTD/GL-GCP/2013/02
p.000004: TABLE OF CONTENTS
p.000004: 1.0. INTRODUCTION
p.000004: 4
p.000004: 2.0. GLOSSARY
p.000005: 5
p.000005: 3.0. RESPONSIBILITIES
p.000005: 5
p.000005: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 10
p.000005: 3.2. INVESTIGATOR
p.000011: 11
p.000011: 3.3. SPONSOR
p.000014: 14
p.000014: 4.0. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
p.000018: 18
p.000018: 4.1. General Information
p.000018: 18
p.000018: 4.2. Background Information
p.000018: 18
p.000018: 4.3. Trial Objectives and Purpose
p.000019: 19
p.000019: 4.4. Trial Design
p.000019: 19
p.000019: 4.5. Selection and Withdrawal of Subjects
p.000020: 20
p.000020: 4.6. Treatment of Subjects
p.000021: 21
p.000021: 4.7. Assessment of Efficacy
p.000021: 21
p.000021: 4.8. Assessment of Safety
p.000021: 21
p.000021: 4.9. Statistics
p.000022: 22
p.000022: 4.10. Direct Access to Source Data/Documents
p.000022: 22
p.000022: 4.11. Quality Control and Quality Assurance
p.000022: 22
p.000022: 4.12. Ethics
p.000023: 23
p.000023: 4.13. Data Handling and Record Keeping
p.000023: 23
p.000023: 4.14. Financing and Insurance
p.000023: 23
p.000023: 4.15. Publication Policy
p.000023: 23
p.000023: 5.0. INVESTIGATOR’S BROCHURE
p.000024: 24
p.000024: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000024: 24
p.000024: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POULATIONS
p.000026: 26
p.000026: APPENDIX I
p.000028: 28
p.000028: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY 28
p.000028: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION 28
p.000028: 2.0. WHAT DOES AN INSPECTION INVOLVE? 28
p.000028: 3.0. THE INSPECTION
p.000028: 28
p.000028: 4.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 30
p.000028: 5.0. TRIAL PROCEDURES
p.000031: 31
p.000031: Page 2 of 48
p.000031:
p.000031: FDA/SMC/CTD/GL-GCP/2013/02
p.000031: 6.0. TRIAL MEDICATION
p.000032: 32
p.000032: 7.0. LABORATORY
p.000033: 33
p.000033: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS 33
p.000033: 9.0. EXIT MEETING / INSPECTION REPORT
p.000034: 34
p.000034: APPENDIX II
p.000035: 35
p.000035: ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 35
p.000035: 1.0. Introduction
p.000035: 35
p.000035: 2.0. Before the Clinical Phase of the Trial Commences
p.000036: 36
p.000036: 3.0. During the Clinical Conduct of the Trial
p.000041: 41
p.000041: 4.0. After Completion or Termination of the Trial
p.000047: 47
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p.000047: Page 3 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 1.0. INTRODUCTION
...
p.000047:
p.000047:
p.000047: “Principal Investigator / Investigator” The person responsible for the conduct of the clinical trial at the clinical
p.000047: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000047: located.
p.000047:
p.000047: “Protocol Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047: “Protocol” A document that describes the objective(s), design, methodology, statistical
p.000047: considerations and the organization of a trial. The protocol usually also gives the background and rationale for the
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
...
p.000047: board(s) within the stipulated time as specified in these guidelines.
p.000047: 6.4.6. The investigator is carrying out the agreed-upon activities, and has not delegated them to other previously
p.000047: unspecified staff.
p.000047:
p.000047: To facilitate the above the Authority may require the submission of specific data listing before or during the conduct
p.000047: of a GCP inspection.
p.000047: 6.5. During an inspection, inspectors:
p.000047: 6.5.1. Should be given easy access to the trial sites and laboratories at all times
p.000047: 6.5.2. Should have easy access to all patient files and raw data utilised for and generated during
p.000047: the trial. All site data and documents including participant files must be available for verification.
p.000047: 6.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that
p.000047: the conclusions that would be presented are derived correctly from the raw data.
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
p.000047: 7.1.2. The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000047: 7.1.3. A parent or legal representative of each child has given permission;
p.000047: 7.1.4. The agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and,
p.000047: 7.1.5. A child`s refusal to participate or continue in the research will be respected.
p.000047:
p.000047:
p.000047: 7.2. Research involving individuals who are cognitively impaired subjects by reason of mental or
p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
...
Health / Cognitive Impairment
Searching for indicator impaired:
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p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
p.000047: protocol, investigators brochure, patient consent forms, insurance for participants, current CV’s for
p.000047: investigators and literature detailing rationale for the study and any other documents that the IRB/ICE
p.000047: may need to fulfill its responsibilities.
p.000047: 3.1.5. The Ethics Committee shall consider the following:
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
p.000047: 3.1.5.2. The suitability of the protocol in relation to the objectives of the study. Its scientific efficiency
...
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
p.000047: 7.1.2. The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000047: 7.1.3. A parent or legal representative of each child has given permission;
p.000047: 7.1.4. The agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and,
p.000047: 7.1.5. A child`s refusal to participate or continue in the research will be respected.
p.000047:
p.000047:
p.000047: 7.2. Research involving individuals who are cognitively impaired subjects by reason of mental or
p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
...
Health / Drug Usage
Searching for indicator drug:
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p.000047:
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 1.0. INTRODUCTION
p.000047: The purpose of these guidelines is to provide investigators conducting clinical trials in Ghana with clear
p.000047: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Ghana are
p.000047: designed and conducted according to sound scientific and ethical standards within the framework of good
p.000047: clinical practice. Compliance with these standards provides the public with assurance that the rights, safety and
p.000047: wellbeing of trial participants are protected and that clinical trial data are credible.
p.000047:
p.000047: The guidelines were partly derived from the International Conference on Harmonization Good Clinical Practice (ICH
p.000047: GCP) and from the International Ethical Guidelines for Biomedical Research involving human subjects prepared by
p.000047: the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with World Health Organization
p.000047: (WHO 2002).
p.000047:
p.000047: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical
p.000047: investigators, industry/sponsors/monitors, institutions/ethics committees, and government regulators. The
p.000047: Guidelines are therefore addressed to investigators, pharmaceutical, manufacturers and other
p.000047: sponsors of research, drug regulatory authorities, the general public and all, those who have an interest in clinical
p.000047: trials research in Ghana.
p.000047:
p.000047: These Guidelines will support the regulatory requirements of the Food and Drugs Authority as stipulated in part 8, Act
p.000047: 851 of the Public Health Act 2012. It is therefore critical that research ethics committees, researchers, trial
p.000047: participants, principal investigators of trials and sponsors use these guidelines so as to ensure a standardized and
p.000047: ethical approach to clinical trial conducted in Ghana.
p.000047:
p.000047: The guidelines are also applicable to academic and contract clinical research and are intended to be applied during all
p.000047: stages of drug development including pre and post product registration and marketing, and they are also applicable, in
p.000047: whole or in part to biomedical research in general. They also provide a resource for editors to determine the
p.000047: acceptability of reported research for publication and specifically, on any study that could influence the use or the
p.000047: terms of registration of a pharmaceutical product.
p.000047: Page 4 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 2.0. GLOSSARY
p.000047: “Adult” A person who is eighteen (18) years of age or over that age.
p.000047:
p.000047:
p.000047: “Adverse Drug Reaction (ADR)” All noxious and unintended responses to a medicinal product related to any dose
p.000047: should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal
p.000047: relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the
p.000047: relationship cannot be ruled out.
p.000047: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at
p.000047: doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
p.000047: physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
p.000047: Expedited Reporting).
p.000047:
p.000047: “Adverse Event (AE)” Any undesirable experience occurring to a subject during a clinical trial, whether or not
p.000047: considered related to the investigational product(s). An unexpected AE is an experience not reported in the
p.000047: current Investigators Brochure or elsewhere.
p.000047:
p.000047: “Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047:
p.000047: “Applicable Regulatory Requirement(s)” Any law(s) and regulation(s) addressing the conduct of clinical trials of
p.000047: investigational products.
p.000047:
p.000047: “Approval(s)” The affirmative decision of the appropriate institutions (FDA, IRB/IEC and GHS- EC) that the clinical
p.000047: trial has been reviewed and may be conducted at the institution site within the constraints set forth by the
p.000047: appropriate institutions, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000047:
p.000047: “Audit Certificate” A declaration of confirmation by the auditor that an audit has taken place.
p.000047:
p.000047:
p.000047: “Audit Report” A written evaluation by the sponsor's auditor of the results of the audit.
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
...
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
p.000047: Form, this is defined as the date when the clinical trial site shall start to enroll participants in the clinical
p.000047: trial.
p.000047:
p.000047: “Drug/Medicine” Includes
p.000047: 1 A substance referred to in a publication mentioned in the Fourth Schedule,
p.000047: 2 A substance or mixture of substances prepared, sold or represented for use in
p.000047: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000047: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical
p.000047: state or the symptoms of it, in man or animal, or
p.000047: 3 Nutritional supplements
p.000047:
p.000047:
p.000047: “FDA” means Food and Drugs Authority
p.000047:
p.000047:
p.000047: “Good Clinical Practice (GCP) Inspection” The act by the FDA of conducting an official review of
p.000047: documents, facilities, records and any other resources that are deemed to be related to the clinical trial and that may
p.000047: be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at
p.000047: other establishments deemed appropriate by the FDA.
p.000047:
p.000047:
p.000047: Page 7 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Good Manufacturing Practice (GMP)” The part of pharmaceutical quality assurance which ensures that products
p.000047: are consistently produced and controlled to quality standards appropriate to their intended use and as required by the
p.000047: marketing authorization.
p.000047:
p.000047: “Herbal Medicinal Product” Includes plant-derived material preparations with therapeutic or any other human
...
p.000047:
p.000047: for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign
p.000047: regulatory authorities.
p.000047: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and
p.000047: have been processed correctly. Agreements, made by the sponsor with the principal investigator and any
p.000047: other parties involved with the clinical trial, should be in writing, as part of the protocol or in a
p.000047: separate agreement.
p.000047:
p.000047: 4.12. Ethics
p.000047: 4.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000047: given to patients or volunteers.
p.000047: 4.12.2. In all circumstances provisions made in the current version of ICH E6 R1 with respect to ethics and informed
p.000047: consent should be complied with.
p.000047:
p.000047: 4.13. Data Handling and Record Keeping
p.000047: 4.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on
p.000047: the case report form (CRF) for each individual taking part in the trial.
p.000047: 4.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000047: 4.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of 5
p.000047: years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily available for
p.000047: review upon request by the Authority.
p.000047:
p.000047: 4.14. Financing and Insurance
p.000047: 4.14.1. Financing and insurance if not addressed in a separate agreement
p.000047:
p.000047:
p.000047: 4.15. Publication Policy
p.000047: 4.15.1. Publication policy, if not addressed in a separate agreement
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 23 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: With respect to issues related to protocol amendments refer to section 3.5 of the FDA Guidelines for the conduct of
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047: 5.0. INVESTIGATOR’S BROCHURE
p.000047: 5.1. Investigators Brochure containing information on the following but not limited to:
p.000047: 5.1.1. Chemical, physical and pharmaceutical properties and formulations,
p.000047: 5.1.2. Preclinical, pharmacological and toxicological data,
p.000047: 5.1.3. Human pharmacological and clinical data with the substance concerned and any other supporting
p.000047: documentation sufficient to establish quality, safety and efficacy where applicable.
p.000047: 5.1.4. Marketing experience in countries where the investigational product is being marketed or
p.000047: approved. Where appropriate there should be discussions of published reports.
p.000047: 5.2. Sample of label to be used for the investigational products.
p.000047: 5.3. Clear instructions on storage and handling of investigational products.
...
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 37.
p.000047: SIGNED INFORMED CONSENT FORMS
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SOURCE DOCUMENTS
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)
p.000047:
p.000047: DOCUMENTATION OF CRF CORRECTIONS
p.000047:
p.000047:
p.000047: NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
p.000047:
p.000047: NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE,
p.000047: To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each
p.000047: subject in trial. Also to document direct access permission (see 3)
p.000047:
p.000047: To document the existence of the subject and substantiate integrity of trial data collected. To include original
p.000047: documents related to the trial, to medical treatment, and history of subject
p.000047:
p.000047: To document that the investigator or authorized member of the investigator’s staff confirms the observations recorded
p.000047:
p.000047: To document all changes/additions or corrections made to CRF after initial data were recorded
p.000047:
p.000047:
p.000047: Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with
p.000047: 3.4 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by Sponsor and/or Investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of
p.000047: unexpected serious adverse drug reactions and of other safety information in
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 45 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 38.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 39.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 40.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 41.
p.000047: TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY
p.000047: INFORMATION NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
p.000047:
p.000047:
p.000047: INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SUBJECT SCREENING LOG
p.000047:
p.000047:
p.000047: SUBJECT IDENTIFICATION CODE LIST
p.000047: accordance with 3.3.14 and 3.2.12.8 of FDA Guidelines for GCP in Ghana and 3.4 of FDA Guidelines for Conducting
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by sponsor to investigators of safety information of findings that could affect adversely
p.000047: the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable
p.000047: opinion to continue the trial.
p.000047:
p.000047:
p.000047: Interim or annual reports provided to IRB/IEC in accordance with approving IRB/IEC requirements and to authority(ies)
p.000047: in accordance with 3.5.1.2 and 3.5.1.3 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047: To document identification of subjects who entered pre-trial screening
p.000047:
p.000047:
p.000047: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers
p.000047: on enrolling in the trial. Allows
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
Searching for indicator influence:
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p.000047:
p.000047: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical
p.000047: investigators, industry/sponsors/monitors, institutions/ethics committees, and government regulators. The
p.000047: Guidelines are therefore addressed to investigators, pharmaceutical, manufacturers and other
p.000047: sponsors of research, drug regulatory authorities, the general public and all, those who have an interest in clinical
p.000047: trials research in Ghana.
p.000047:
p.000047: These Guidelines will support the regulatory requirements of the Food and Drugs Authority as stipulated in part 8, Act
p.000047: 851 of the Public Health Act 2012. It is therefore critical that research ethics committees, researchers, trial
p.000047: participants, principal investigators of trials and sponsors use these guidelines so as to ensure a standardized and
p.000047: ethical approach to clinical trial conducted in Ghana.
p.000047:
p.000047: The guidelines are also applicable to academic and contract clinical research and are intended to be applied during all
p.000047: stages of drug development including pre and post product registration and marketing, and they are also applicable, in
p.000047: whole or in part to biomedical research in general. They also provide a resource for editors to determine the
p.000047: acceptability of reported research for publication and specifically, on any study that could influence the use or the
p.000047: terms of registration of a pharmaceutical product.
p.000047: Page 4 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 2.0. GLOSSARY
p.000047: “Adult” A person who is eighteen (18) years of age or over that age.
p.000047:
p.000047:
p.000047: “Adverse Drug Reaction (ADR)” All noxious and unintended responses to a medicinal product related to any dose
p.000047: should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal
p.000047: relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the
p.000047: relationship cannot be ruled out.
p.000047: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at
p.000047: doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
p.000047: physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
p.000047: Expedited Reporting).
p.000047:
p.000047: “Adverse Event (AE)” Any undesirable experience occurring to a subject during a clinical trial, whether or not
p.000047: considered related to the investigational product(s). An unexpected AE is an experience not reported in the
p.000047: current Investigators Brochure or elsewhere.
p.000047:
...
Searching for indicator substance:
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p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
p.000047: Form, this is defined as the date when the clinical trial site shall start to enroll participants in the clinical
p.000047: trial.
p.000047:
p.000047: “Drug/Medicine” Includes
p.000047: 1 A substance referred to in a publication mentioned in the Fourth Schedule,
p.000047: 2 A substance or mixture of substances prepared, sold or represented for use in
p.000047: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000047: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical
p.000047: state or the symptoms of it, in man or animal, or
p.000047: 3 Nutritional supplements
p.000047:
p.000047:
p.000047: “FDA” means Food and Drugs Authority
p.000047:
p.000047:
p.000047: “Good Clinical Practice (GCP) Inspection” The act by the FDA of conducting an official review of
p.000047: documents, facilities, records and any other resources that are deemed to be related to the clinical trial and that may
p.000047: be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at
p.000047: other establishments deemed appropriate by the FDA.
p.000047:
p.000047:
p.000047: Page 7 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Good Manufacturing Practice (GMP)” The part of pharmaceutical quality assurance which ensures that products
p.000047: are consistently produced and controlled to quality standards appropriate to their intended use and as required by the
p.000047: marketing authorization.
p.000047:
p.000047: “Herbal Medicinal Product” Includes plant-derived material preparations with therapeutic or any other human
p.000047: health benefits which contain raw or processed ingredients from one or more plants and materials or organic or animal
p.000047: origin.
p.000047:
p.000047: “Institutional Review Board/Independent Ethics Committee (IRB/IEC)” An independent body constituted of medical,
...
p.000047: 4.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on
p.000047: the case report form (CRF) for each individual taking part in the trial.
p.000047: 4.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000047: 4.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of 5
p.000047: years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily available for
p.000047: review upon request by the Authority.
p.000047:
p.000047: 4.14. Financing and Insurance
p.000047: 4.14.1. Financing and insurance if not addressed in a separate agreement
p.000047:
p.000047:
p.000047: 4.15. Publication Policy
p.000047: 4.15.1. Publication policy, if not addressed in a separate agreement
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 23 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: With respect to issues related to protocol amendments refer to section 3.5 of the FDA Guidelines for the conduct of
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047: 5.0. INVESTIGATOR’S BROCHURE
p.000047: 5.1. Investigators Brochure containing information on the following but not limited to:
p.000047: 5.1.1. Chemical, physical and pharmaceutical properties and formulations,
p.000047: 5.1.2. Preclinical, pharmacological and toxicological data,
p.000047: 5.1.3. Human pharmacological and clinical data with the substance concerned and any other supporting
p.000047: documentation sufficient to establish quality, safety and efficacy where applicable.
p.000047: 5.1.4. Marketing experience in countries where the investigational product is being marketed or
p.000047: approved. Where appropriate there should be discussions of published reports.
p.000047: 5.2. Sample of label to be used for the investigational products.
p.000047: 5.3. Clear instructions on storage and handling of investigational products.
p.000047: 5.4. An updated investigator’s brochure should be submitted whenever updated or at least once a year. Additional
p.000047: information and any changes that have been incorporated in the updated investigator’s brochure should be
p.000047: highlighted for ease of review and evaluation
p.000047: 5.5. Good Manufacturing Practice (GMP) certificate/statement from the country of manufacture for
p.000047: the product/ placebo issued by the competent recognized Authority.
p.000047:
p.000047: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000047: The FDA reserves the right to interrupt and inspect any trial for which authorization has been given, as and when
p.000047: necessary for a good cause. An inspection of the conduct of a clinical trial by on-site visits forms part of the
p.000047: Authority’s monitoring activities.
p.000047: 6.1. Periodic Good Clinical Practice (GCP) Inspections of the trial sites shall be conducted to ensure that the
p.000047: facilities used continue to be acceptable throughout the clinical investigation.
p.000047:
p.000047:
p.000047: Page 24 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
...
p.000047: including results of lab tests, development of unrelated illness and other factors which might alter the effects
p.000047: of the test article
p.000047: 5.12. Records of exposure of the participant to the test article.
p.000047: 5.13. Whether clinical laboratory testing (including ecgs x-rays and other special investigations), as noted
p.000047: in the case reports, can't be evaluated by the presence of completed laboratory reports in the source documents.
p.000047: 5.14. The occurrence of adverse reactions would be determined. The reporting of these events to FDA and the Ethics
p.000047: Committee shall be documented.
p.000047: 5.15. All persons obtaining raw data or involved in the collection or analysis of such data would be identified.
p.000047:
p.000047: 6.0. TRIAL MEDICATION
p.000047: With regard to trial medication the following are considered as important in an inspection:
p.000047: 6.1. Determination of accounting procedures for the test and comparator drugs.
p.000047: 6.2. Dates and quantity of trial medication dispensed as well as the recipients must be available as well as
p.000047: corroboration by raw data notations.
p.000047: 6.3. The blinding of medication, if appropriate, must be validated to ensure protection of the study from bias.
p.000047:
p.000047: Page 32 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.4. It shall be determined whether distribution of the article was limited to those persons under the
p.000047: investigator's direct supervision.
p.000047: 6.5. The storage area may be inspected.
p.000047: 6.6. It would be determined whether the test article is a controlled substance and whether it is securely
p.000047: locked
p.000047: 6.7. Access to the controlled substance must be restricted to the investigator and the responsible pharmacist.
p.000047:
p.000047: 7.0. LABORATORY
p.000047: The FDA during an inspection would determine the systems and procedures that are followed within an organization that
p.000047: is conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice
p.000047: (GCP).
p.000047:
p.000047: Inspections of a laboratory being used to analyze samples from a clinical trial shall be in accordance
p.000047: with provisions outlined in the Good Clinical Laboratory Practice Guidelines published by WHO/TDR.
p.000047:
p.000047: 7.1 Transfer of Biological Samples
p.000047: No person shall make arrangements to receive or ship biological samples from a clinical trial without
p.000047: prior approval from the Authority.
p.000047:
p.000047: Persons who wish to import or export any biological samples from a clinical trial shall submit an application and a
p.000047: suitable Material Transfer Agreement for approval by the Authority. The application must be accompanied
p.000047: with the appropriate clearance from a reputable Ethics Committee or Institutional Review Board in Ghana.
p.000047:
p.000047:
p.000047: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS
p.000047: If electronic data systems are involved in gathering data, storing data, or transmitting data to the sponsor, these
p.000047: would be identified and their capabilities established. The following are important:
p.000047: 8.1 The source of data entered into the computer
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
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Health / Healthy People
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p.000047: review, and regulatory inspection(s), providing direct access to source data/documents.
p.000047:
p.000047: 4.11. Quality Control and Quality Assurance
p.000047: 4.11.1. The sponsor is responsible for implementing and maintaining quality assurance and quality control
p.000047: systems with written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are
p.000047: generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory
p.000047: requirement(s).
p.000047: 4.11.2. The sponsor is responsible for securing agreement from all involved parties to ensure direct
p.000047: access to all trial related sites, source data/documents, and reports
p.000047:
p.000047:
p.000047: Page 22 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign
p.000047: regulatory authorities.
p.000047: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and
p.000047: have been processed correctly. Agreements, made by the sponsor with the principal investigator and any
p.000047: other parties involved with the clinical trial, should be in writing, as part of the protocol or in a
p.000047: separate agreement.
p.000047:
p.000047: 4.12. Ethics
p.000047: 4.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000047: given to patients or volunteers.
p.000047: 4.12.2. In all circumstances provisions made in the current version of ICH E6 R1 with respect to ethics and informed
p.000047: consent should be complied with.
p.000047:
p.000047: 4.13. Data Handling and Record Keeping
p.000047: 4.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on
p.000047: the case report form (CRF) for each individual taking part in the trial.
p.000047: 4.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000047: 4.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of 5
p.000047: years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily available for
p.000047: review upon request by the Authority.
p.000047:
p.000047: 4.14. Financing and Insurance
p.000047: 4.14.1. Financing and insurance if not addressed in a separate agreement
p.000047:
p.000047:
p.000047: 4.15. Publication Policy
p.000047: 4.15.1. Publication policy, if not addressed in a separate agreement
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 23 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: With respect to issues related to protocol amendments refer to section 3.5 of the FDA Guidelines for the conduct of
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047: 5.0. INVESTIGATOR’S BROCHURE
p.000047: 5.1. Investigators Brochure containing information on the following but not limited to:
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000047: requirements.
p.000047:
p.000047: “Lot Release Certificate (LRC)” An official document that authorizes the manufacturer to release a specific
p.000047: lot of a product.
p.000047:
p.000047:
p.000047: Page 8 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Medical Device” As defined in Part Seven, Section 149 of the Public Health Act 2012, Act 851.
p.000047:
p.000047:
p.000047: “Placebo” A medication with no active ingredients or a procedure without any medical benefit.
p.000047:
p.000047:
p.000047: “Principal Investigator / Investigator” The person responsible for the conduct of the clinical trial at the clinical
p.000047: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000047: located.
p.000047:
p.000047: “Protocol Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047: “Protocol” A document that describes the objective(s), design, methodology, statistical
p.000047: considerations and the organization of a trial. The protocol usually also gives the background and rationale for the
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
...
Health / Motherhood/Family
Searching for indicator family:
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p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
...
Health / Physically Disabled
Searching for indicator illness:
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p.000047: the Helsinki Declaration and its current revisions as well as in the local and international guidelines for GCP.
p.000047: 3.2.11. Adequate Resources
p.000047: 3.2.11.1. The Investigator should have sufficient time to properly conduct and complete the trial within the agreed
p.000047: trial period.
p.000047: 3.2.11.2. The Investigator should have adequate number of qualified staff and adequate facilities for the
p.000047: duration of the trial to conduct the trial properly and safely.
p.000047: 3.2.11.3. The Investigator should ensure that all persons assisting with the trial are adequately informed
p.000047: about the protocol, investigational product and their trial- related duties and functions.
p.000047: 3.2.12. Medical Care of Trial Subjects
p.000047: 3.2.11.1. A qualified medical practitioner should be responsible for all trial-related medical decisions.
p.000047: The qualified medical practitioner should also be licensed with the Medical and Dental Council of Ghana. The
p.000047: medical care given to, and medical decisions made on behalf of the subjects must always be the
p.000047:
p.000047:
p.000047: Page 12 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: responsibility of a qualified medical practitioner or when appropriate a qualified dentist registered with the
p.000047: Medical and Dental Council.
p.000047: 3.2.11.2. During and following a subject’s participation in a trial, the Investigator should ensure
p.000047: adequate medical care is provided to a subject for any adverse events including clinically significant laboratory
p.000047: values related to the trial. The subject should be informed when medical care is needed for inter-current illness
p.000047: for which the Investigator becomes aware.
p.000047:
p.000047: 3.2.13. Other Investigator Responsibilities
p.000047: 3.2.12.1. Before initiating a trial, the Principal Investigator should have the written and dated approval from
p.000047: the Food and Drugs Authority (FDA) and other relevant bodies.
p.000047: 3.2.12.2. The Investigator should conduct the trial according to the approved protocol.
p.000047: 3.2.12.3. The Investigator shall not implement any deviation from or changes to the protocol and
p.000047: Informed Consent Form without prior review and approval of the FDA except when the changes involve only
p.000047: logistical or administrative aspects of the trial e.g. monitor or telephone number changes or is based on issues
p.000047: relating to the immediate safety of subjects already recruited into the trial.
p.000047: 3.2.12.4. The Investigator shall establish SOPs for investigational products (IP): 3.2.12.4.1. The IP(s)
p.000047: should be kept by a designated person (a
p.000047: pharmacist) who maintain records of the delivery process and who ensures that the product is processed and stored
p.000047: correctly. 3.2.12.4.2. The designated person should maintain an inventory of the IP at the site, those used by
p.000047: each subject and the return to
p.000047: sponsor or alternative disposition of unused product(s).
p.000047: 3.2.12.4.3. The Investigational product(s) should be used only on the subjects participating in the trial.
p.000047: 3.2.12.4.4. The Investigator should ensure that the IP are used only in accordance with the approved
p.000047: protocol.
p.000047:
p.000047:
p.000047: Page 13 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
...
p.000047: 5.3. Validation of signed informed consent documents. Signatures shall be checked against evidence on
p.000047: patient files. It would be determined whether written informed consent was obtained for all participants
p.000047: prior to the entry into the study and whether this was recorded in the participants medical records. A copy of the
p.000047: information presented orally may also be obtained.
p.000047: 5.4. Participant records shall be verified.
p.000047: 5.5. The condition, organization, completeness and legibility of the investigator's raw data files may need to be
p.000047: described.
p.000047:
p.000047: Page 31 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 5.6. Necessary processes would be put in place to determine whether there is adequate documentation to
p.000047: assure that all inspected participants did exist and were available for the duration of their stated
p.000047: participation in the study.
p.000047: 5.7. The raw data in the clinical investigator's records would be compared with the completed case record forms.
p.000047: The following shall also be determined:
p.000047: 5.8. Whether the number and type of participants entered into the study were confined to the protocol limitations
p.000047: 5.9. Whether the inclusion and exclusion criteria as specified in the protocol were followed
p.000047: 5.10. Observations, information, and data condition of the participants at the time of entering into the trial.
p.000047: 5.11. Observations and data on the condition of the participant throughout participation in the investigation,
p.000047: including results of lab tests, development of unrelated illness and other factors which might alter the effects
p.000047: of the test article
p.000047: 5.12. Records of exposure of the participant to the test article.
p.000047: 5.13. Whether clinical laboratory testing (including ecgs x-rays and other special investigations), as noted
p.000047: in the case reports, can't be evaluated by the presence of completed laboratory reports in the source documents.
p.000047: 5.14. The occurrence of adverse reactions would be determined. The reporting of these events to FDA and the Ethics
p.000047: Committee shall be documented.
p.000047: 5.15. All persons obtaining raw data or involved in the collection or analysis of such data would be identified.
p.000047:
p.000047: 6.0. TRIAL MEDICATION
p.000047: With regard to trial medication the following are considered as important in an inspection:
p.000047: 6.1. Determination of accounting procedures for the test and comparator drugs.
p.000047: 6.2. Dates and quantity of trial medication dispensed as well as the recipients must be available as well as
p.000047: corroboration by raw data notations.
p.000047: 6.3. The blinding of medication, if appropriate, must be validated to ensure protection of the study from bias.
p.000047:
p.000047: Page 32 of 48
p.000047:
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p.000047:
p.000047: 6.4. It shall be determined whether distribution of the article was limited to those persons under the
p.000047: investigator's direct supervision.
p.000047: 6.5. The storage area may be inspected.
p.000047: 6.6. It would be determined whether the test article is a controlled substance and whether it is securely
p.000047: locked
...
Health / Pregnant
Searching for indicator pregnant:
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p.000047: considerations and the organization of a trial. The protocol usually also gives the background and rationale for the
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
p.000047: protocol, investigators brochure, patient consent forms, insurance for participants, current CV’s for
p.000047: investigators and literature detailing rationale for the study and any other documents that the IRB/ICE
p.000047: may need to fulfill its responsibilities.
p.000047: 3.1.5. The Ethics Committee shall consider the following:
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
...
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
p.000047: 1.1. The phase of the clinical trial
p.000047: 1.2. The nature of the investigational product.
p.000047: 1.3. The market authorization status of the investigational product
p.000047: 1.4. The population under study
p.000047: 1.5. Capacity of trial site
p.000047: 1.6. Previous experience of FDA with sponsor/principal investigator with respect to compliance to GCP
p.000047: requirements.
p.000047:
p.000047: 2.0. WHAT DOES AN INSPECTION INVOLVE?
p.000047: The inspection may involve:
p.000047: 2.1. A comparison of the practices and procedures of the clinical investigator with the commitments made in the
p.000047: application to conduct a clinical trial;
p.000047: 2.2. A comparison of the data submitted to the authority with the source data; and/or
p.000047: 2.3. A system inspection of the sponsor, clinical laboratory or CRO generating data for submission to
p.000047: regulatory authorities. This may include inspection of both the clinical facility and analytical facility.
p.000047:
p.000047: 3.0. THE INSPECTION
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Health / visual impairment
Searching for indicator blind:
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p.000047: 4.2.4. Summary of the known and potential risks and benefits, if any, to human subjects.
p.000047: 4.2.5. Description of and justification for the route of administration, dosage, dosage regimen, and
p.000047: treatment period(s).
p.000047: 4.2.6. A statement that the trial shall be conducted in compliance with the protocol, GCP and the applicable
p.000047: regulatory requirement(s).
p.000047: 4.2.7. Description of the population to be studied.
p.000047: 4.2.8. References to literature and data that are relevant to the trial and that provide background
p.000047: for the trial.
p.000047: 4.2.9. Signed declaration by the applicant and all investigators that they are familiar with and
p.000047: understand the protocol and shall comply with principles of Good Clinical Practice (GCP) as determined by
p.000047: the Food and Drugs Authority in the conduct of the trial.
p.000047: 4.2.10. Explanation of the trial being conducted in Ghana and not in the host country of applicant or Sponsor.
p.000047:
p.000047: 4.3. Trial Objectives and Purpose
p.000047: 4.3.1. A detailed description of the objectives and the purpose of the trial.
p.000047: 4.3.2. Aim of the trial and reason for its execution.
p.000047:
p.000047:
p.000047: 4.4. Trial Design
p.000047: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000047: substantially on the trial design. A description of the trial design should include:
p.000047: 4.4.1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the
p.000047: trial.
p.000047: 4.4.2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled, parallel
p.000047: design) and a schematic diagram of trial design, procedures and stages.
p.000047: 4.4.3. A description of the measures taken to minimize/avoid bias, including randomization
p.000047: and blinding.
p.000047:
p.000047:
p.000047:
p.000047: Page 19 of 48
p.000047:
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p.000047:
p.000047: 4.4.4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000047: product(s).
p.000047: 4.4.5. Description of the dosage form, packaging, and labeling of the investigational product(s) and sample
p.000047: of label to be used for investigational product.
p.000047: 4.4.6. The expected duration of subject participation, and a description of the sequence and duration of
p.000047: all trial periods, including follow-up, if any.
p.000047: 4.4.7. Quantities of investigational medicines and placebos to be used during the conduct of the study.
p.000047: 4.4.8. A detailed description of the "stopping rules" or "discontinuation criteria" for individual
p.000047: subjects, parts of trial and entire trial.
p.000047: 4.4.9. Accountability procedures for the investigational product(s), including the placebo(s) and
p.000047: comparator(s), if any.
p.000047: 4.4.10. Maintenance of trial treatment randomization codes and procedures for breaking codes.
p.000047: 4.4.11. The identification of any data to be recorded directly on the CRFs (i.e. written or electronic record of
p.000047: data), and to be considered to be source data
p.000047: 4.4.12. Number of human subjects to be involved in the trial and the statistical justification.
...
p.000047:
p.000047:
p.000047:
p.000047: To document instructions needed to ensure proper X X storage, packaging,
p.000047: dispensing and disposition of
p.000047: investigational products and trial-related materials
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document shipment dates, batch numbers and X X method of shipment of
p.000047: investigational product(s)
p.000047: and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document identity, purity, and strength of X investigational
p.000047: product(s) to be used in the trial
p.000047: Page 40 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000047:
p.000047:
p.000047: 17.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 18.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 19.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 20.
p.000047: DECODING PROCEDURES FOR BLINDED TRIALS
p.000047:
p.000047:
p.000047: MASTER RANDOMISATION LIST
p.000047:
p.000047: PRE-TRIAL MONITORING REPORT
p.000047:
p.000047:
p.000047: TRIAL INITIATION MONITORING REPORT
p.000047: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000047: the blind for the remaining subjects' treatment
p.000047:
p.000047: To document method for randomization of trial population
p.000047:
p.000047:
p.000047: To document that the site is suitable for the trial (may be combined with 20)
p.000047:
p.000047:
p.000047: To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be
p.000047: combined with 19)
p.000047: X X
p.000047: (a third party if applicable)
p.000047:
p.000047:
p.000047: X
p.000047: (a third party if applicable)
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: 3.0. During the Clinical Conduct of the Trial
p.000047: In addition to having on file the above documents, the following should be added to the files during the trial as
p.000047: evidence that all new relevant information is documented as it becomes available
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of
p.000047: Investigator /Sponsor Sp
p.000047: or
p.000047:
p.000047:
p.000047: 21.
p.000047: INVESTIGATOR’S BROCHURE UPDATES
p.000047: To document that investigator is informed in a X X timely manner of
p.000047: relevant information as it
p.000047: becomes available
p.000047:
p.000047:
p.000047: Page 41 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 22.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 23.
p.000047: ANY REVISION TO:
p.000047: - Protocol/amendment(s) and CRF
...
Searching for indicator blinded:
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p.000047: An updated Investigator’s Brochure shall be submitted whenever available; at least once year.
p.000047: 3.3.5. The Sponsor shall obtain the investigator’s/institutions’ agreement on the following
p.000047: items:
p.000047: 3.3.5.1. The conduct of the trial in compliance with Good Clinical Practices and with the approved protocol; and
p.000047: to be in compliance with procedures for data recording/reporting and to permit monitoring, auditing
p.000047: and inspection according to the protocol.
p.000047: 3.3.5.2. The Sponsor and all investigators shall sign and date the protocol of the trial to confirm the agreement.
p.000047: 3.3.6. The Sponsor shall ensure that sufficient safety and efficacy data from non-clinical studies and/or
p.000047: clinical trials are available to support human exposure by the route, at the dosages for the duration and in the trial
p.000047: population to be studied.
p.000047: 3.3.7. The Sponsor shall ensure that the IP’s (including active comparator(s) and placebo) is manufactured in
p.000047: accordance with Good Manufacturing Practices and are adequately packed and labelled in a manner that protects the
p.000047: blinding if applicable. In addition
p.000047:
p.000047:
p.000047: Page 15 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: the labelling should comply with the regulatory requirements (refer to FDA’s Guidelines for Labeling of
p.000047: Products).
p.000047: 3.3.8. The Sponsor shall determine for the IP’s, acceptable storage temperature and conditions, storage
p.000047: times, reconstitution fluids and procedures and devices for product infusion if any.
p.000047: 3.3.9. In blinded trials, the coding system for the IP’s shall include a mechanism that permits rapid
p.000047: identification of the products in case of a medical emergency but does not permit undetectable breaks of the blinding.
p.000047: 3.3.10. If formulation changes are made to the IP or comparator products during the course of the clinical
p.000047: development, the results of pharmaceutical and pharmacokinetic profile of the product shall be made available to the
p.000047: FDA prior to the use of the reformulated IP in clinical trials.
p.000047: 3.3.11. The Sponsor shall appoint qualified and suitable trained individuals to monitor the trial.
p.000047: 3.3.12. The Sponsor should provide insurance cover for all trial subjects. The Sponsor’s policies and
p.000047: procedures should address the costs of treatment of trial subjects in the event of trial-related injuries.
p.000047: 3.3.13. The financial aspects of the trial should be documented in an agreement between the Sponsor and the
p.000047: Investigator/institution.
p.000047: 3.3.14. The Sponsor should report to the FDA and all relevant institutions, all adverse events occurring during
p.000047: the course of the trial. The Sponsor should expedite reporting all serious adverse events to the Ethics
p.000047: Committee, the FDA and the Sponsor and the Investigators should immediately undertake appropriate and necessary
p.000047: measures and treatment to protect the trial subjects. (Refer to Guidelines for the Conduct of Clinical Trials for
p.000047: timelines).
...
p.000047: 16.
p.000047: SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S) INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL
p.000047: PRODUCT(S) AND TRIAL-RELATED
p.000047: MATERIALS (if not included in protocol or Investigator’s Brochure)
p.000047:
p.000047: SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS
p.000047:
p.000047:
p.000047: CERTIFICATE(S) OF ANALYSIS OF
p.000047: To document compliance with applicable X labelling regulations and
p.000047: appropriateness of
p.000047: instructions provided to the subjects
p.000047:
p.000047:
p.000047:
p.000047: To document instructions needed to ensure proper X X storage, packaging,
p.000047: dispensing and disposition of
p.000047: investigational products and trial-related materials
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document shipment dates, batch numbers and X X method of shipment of
p.000047: investigational product(s)
p.000047: and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document identity, purity, and strength of X investigational
p.000047: product(s) to be used in the trial
p.000047: Page 40 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000047:
p.000047:
p.000047: 17.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 18.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 19.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 20.
p.000047: DECODING PROCEDURES FOR BLINDED TRIALS
p.000047:
p.000047:
p.000047: MASTER RANDOMISATION LIST
p.000047:
p.000047: PRE-TRIAL MONITORING REPORT
p.000047:
p.000047:
p.000047: TRIAL INITIATION MONITORING REPORT
p.000047: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000047: the blind for the remaining subjects' treatment
p.000047:
p.000047: To document method for randomization of trial population
p.000047:
p.000047:
p.000047: To document that the site is suitable for the trial (may be combined with 20)
p.000047:
p.000047:
p.000047: To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be
p.000047: combined with 19)
p.000047: X X
p.000047: (a third party if applicable)
p.000047:
p.000047:
p.000047: X
p.000047: (a third party if applicable)
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: 3.0. During the Clinical Conduct of the Trial
p.000047: In addition to having on file the above documents, the following should be added to the files during the trial as
p.000047: evidence that all new relevant information is documented as it becomes available
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of
p.000047: Investigator /Sponsor Sp
p.000047: or
p.000047:
p.000047:
p.000047: 21.
p.000047: INVESTIGATOR’S BROCHURE UPDATES
p.000047: To document that investigator is informed in a X X timely manner of
p.000047: relevant information as it
p.000047: becomes available
p.000047:
p.000047:
p.000047: Page 41 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 22.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
Social / Access to Social Goods
Searching for indicator access:
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p.000004:
p.000004:
p.000004:
p.000004:
p.000004: FOOD AND DRUGS AUTHORITY
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: GUIDELINES FOR GOOD CLINICAL PRACTICE IN GHANA
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Document No. : FDA/SMC/CTD/GL-GCP/2013/02
p.000004: Date of First Adoption : 1st February, 2013
p.000004: Date of Issue : 1st March, 2013
p.000004: Version No. 01
p.000004:
p.000004: FDA/SMC/CTD/GL-GCP/2013/02
p.000004: TABLE OF CONTENTS
p.000004: 1.0. INTRODUCTION
p.000004: 4
p.000004: 2.0. GLOSSARY
p.000005: 5
p.000005: 3.0. RESPONSIBILITIES
p.000005: 5
p.000005: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 10
p.000005: 3.2. INVESTIGATOR
p.000011: 11
p.000011: 3.3. SPONSOR
p.000014: 14
p.000014: 4.0. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
p.000018: 18
p.000018: 4.1. General Information
p.000018: 18
p.000018: 4.2. Background Information
p.000018: 18
p.000018: 4.3. Trial Objectives and Purpose
p.000019: 19
p.000019: 4.4. Trial Design
p.000019: 19
p.000019: 4.5. Selection and Withdrawal of Subjects
p.000020: 20
p.000020: 4.6. Treatment of Subjects
p.000021: 21
p.000021: 4.7. Assessment of Efficacy
p.000021: 21
p.000021: 4.8. Assessment of Safety
p.000021: 21
p.000021: 4.9. Statistics
p.000022: 22
p.000022: 4.10. Direct Access to Source Data/Documents
p.000022: 22
p.000022: 4.11. Quality Control and Quality Assurance
p.000022: 22
p.000022: 4.12. Ethics
p.000023: 23
p.000023: 4.13. Data Handling and Record Keeping
p.000023: 23
p.000023: 4.14. Financing and Insurance
p.000023: 23
p.000023: 4.15. Publication Policy
p.000023: 23
p.000023: 5.0. INVESTIGATOR’S BROCHURE
p.000024: 24
p.000024: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000024: 24
p.000024: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POULATIONS
p.000026: 26
p.000026: APPENDIX I
p.000028: 28
p.000028: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY 28
p.000028: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION 28
p.000028: 2.0. WHAT DOES AN INSPECTION INVOLVE? 28
p.000028: 3.0. THE INSPECTION
p.000028: 28
p.000028: 4.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 30
p.000028: 5.0. TRIAL PROCEDURES
p.000031: 31
p.000031: Page 2 of 48
p.000031:
p.000031: FDA/SMC/CTD/GL-GCP/2013/02
p.000031: 6.0. TRIAL MEDICATION
p.000032: 32
p.000032: 7.0. LABORATORY
p.000033: 33
p.000033: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS 33
p.000033: 9.0. EXIT MEETING / INSPECTION REPORT
p.000034: 34
p.000034: APPENDIX II
p.000035: 35
p.000035: ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 35
p.000035: 1.0. Introduction
p.000035: 35
p.000035: 2.0. Before the Clinical Phase of the Trial Commences
p.000036: 36
p.000036: 3.0. During the Clinical Conduct of the Trial
...
p.000047: 4.8.3. Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.
p.000047: 4.8.4. The type and duration of the follow-up of subjects after adverse events.
p.000047: 4.8.5. Provision for dealing with all adverse events. Copy of form to be used to report adverse event.
p.000047: 4.8.6. Criteria for the termination of the trial
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 21 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 4.9. Statistics
p.000047: 4.9.1. A description of the statistical methods to be employed, including timing of any planned interim
p.000047: analysis(ses).
p.000047: 4.9.2. The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects
p.000047: projected for each trial site should be specified.
p.000047: 4.9.3. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and
p.000047: clinical justification.
p.000047: 4.9.4. The level of significance to be used.
p.000047: 4.9.5. Criteria for the termination of the trial.
p.000047: 4.9.6. Methods for data analyses and evaluation of results.
p.000047: 4.9.7. Procedure for accounting for missing, unused, and spurious data.
p.000047: 4.9.8. Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from
p.000047: the original statistical plan should be described and justified in protocol and/or in the final report, as
p.000047: appropriate).
p.000047: 4.9.9. The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed
p.000047: subjects, all eligible subjects, evaluable subjects).
p.000047:
p.000047: 4.10. Direct Access to Source Data/Documents
p.000047: 4.10.1. The sponsor should ensure that it is specified in the protocol or other written agreement that
p.000047: the investigator(s)/institution(s) will permit trial-related monitoring, audits, ethics committee
p.000047: review, and regulatory inspection(s), providing direct access to source data/documents.
p.000047:
p.000047: 4.11. Quality Control and Quality Assurance
p.000047: 4.11.1. The sponsor is responsible for implementing and maintaining quality assurance and quality control
p.000047: systems with written Standard Operating Procedures (SOPs) to ensure that trials are conducted and data are
p.000047: generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory
p.000047: requirement(s).
p.000047: 4.11.2. The sponsor is responsible for securing agreement from all involved parties to ensure direct
p.000047: access to all trial related sites, source data/documents, and reports
p.000047:
p.000047:
p.000047: Page 22 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign
p.000047: regulatory authorities.
p.000047: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and
p.000047: have been processed correctly. Agreements, made by the sponsor with the principal investigator and any
p.000047: other parties involved with the clinical trial, should be in writing, as part of the protocol or in a
p.000047: separate agreement.
p.000047:
p.000047: 4.12. Ethics
p.000047: 4.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000047: given to patients or volunteers.
p.000047: 4.12.2. In all circumstances provisions made in the current version of ICH E6 R1 with respect to ethics and informed
p.000047: consent should be complied with.
p.000047:
p.000047: 4.13. Data Handling and Record Keeping
p.000047: 4.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on
p.000047: the case report form (CRF) for each individual taking part in the trial.
p.000047: 4.13.2. A clear statement on composition and benefit package for clinical trial participants.
...
p.000047:
p.000047:
p.000047: Page 24 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.2. The inspections may be carried out randomly, and/or for specific reasons and shall be either
p.000047: announced or unannounced.
p.000047: 6.3. An inspection would consist of a comparison of the procedures and practices of the principal
p.000047: investigator with the commitments set out in the protocol and reports submitted to the Authority by the investigator or
p.000047: the sponsor.
p.000047: 6.4. During the inspection the FDA shall assure itself that:
p.000047: 6.4.1. The facilities used by the investigator continue to be acceptable for the purposes of the study.
p.000047: 6.4.2. The approved study protocol for the investigation is being followed.
p.000047: 6.4.3. Any changes to the protocol have been approved by respective Ethics Committees and the Authority.
p.000047: 6.4.4. Accurate, complete and current records are being maintained.
p.000047: 6.4.5. Serious adverse events (SAEs) are reported to the sponsor and to the FDA and institutional review
p.000047: board(s) within the stipulated time as specified in these guidelines.
p.000047: 6.4.6. The investigator is carrying out the agreed-upon activities, and has not delegated them to other previously
p.000047: unspecified staff.
p.000047:
p.000047: To facilitate the above the Authority may require the submission of specific data listing before or during the conduct
p.000047: of a GCP inspection.
p.000047: 6.5. During an inspection, inspectors:
p.000047: 6.5.1. Should be given easy access to the trial sites and laboratories at all times
p.000047: 6.5.2. Should have easy access to all patient files and raw data utilised for and generated during
p.000047: the trial. All site data and documents including participant files must be available for verification.
p.000047: 6.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that
p.000047: the conclusions that would be presented are derived correctly from the raw data.
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
...
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
...
p.000047: of the test article
p.000047: 5.12. Records of exposure of the participant to the test article.
p.000047: 5.13. Whether clinical laboratory testing (including ecgs x-rays and other special investigations), as noted
p.000047: in the case reports, can't be evaluated by the presence of completed laboratory reports in the source documents.
p.000047: 5.14. The occurrence of adverse reactions would be determined. The reporting of these events to FDA and the Ethics
p.000047: Committee shall be documented.
p.000047: 5.15. All persons obtaining raw data or involved in the collection or analysis of such data would be identified.
p.000047:
p.000047: 6.0. TRIAL MEDICATION
p.000047: With regard to trial medication the following are considered as important in an inspection:
p.000047: 6.1. Determination of accounting procedures for the test and comparator drugs.
p.000047: 6.2. Dates and quantity of trial medication dispensed as well as the recipients must be available as well as
p.000047: corroboration by raw data notations.
p.000047: 6.3. The blinding of medication, if appropriate, must be validated to ensure protection of the study from bias.
p.000047:
p.000047: Page 32 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.4. It shall be determined whether distribution of the article was limited to those persons under the
p.000047: investigator's direct supervision.
p.000047: 6.5. The storage area may be inspected.
p.000047: 6.6. It would be determined whether the test article is a controlled substance and whether it is securely
p.000047: locked
p.000047: 6.7. Access to the controlled substance must be restricted to the investigator and the responsible pharmacist.
p.000047:
p.000047: 7.0. LABORATORY
p.000047: The FDA during an inspection would determine the systems and procedures that are followed within an organization that
p.000047: is conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice
p.000047: (GCP).
p.000047:
p.000047: Inspections of a laboratory being used to analyze samples from a clinical trial shall be in accordance
p.000047: with provisions outlined in the Good Clinical Laboratory Practice Guidelines published by WHO/TDR.
p.000047:
p.000047: 7.1 Transfer of Biological Samples
p.000047: No person shall make arrangements to receive or ship biological samples from a clinical trial without
p.000047: prior approval from the Authority.
p.000047:
p.000047: Persons who wish to import or export any biological samples from a clinical trial shall submit an application and a
p.000047: suitable Material Transfer Agreement for approval by the Authority. The application must be accompanied
p.000047: with the appropriate clearance from a reputable Ethics Committee or Institutional Review Board in Ghana.
p.000047:
p.000047:
p.000047: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS
p.000047: If electronic data systems are involved in gathering data, storing data, or transmitting data to the sponsor, these
p.000047: would be identified and their capabilities established. The following are important:
p.000047: 8.1 The source of data entered into the computer
p.000047:
p.000047: Page 33 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 8.2 The qualification of the personnel to enter data
p.000047: 8.3 At which time/stage should the entering be done
p.000047: 8.4 Provision for access to data and computer
p.000047: 8.5 Security codes
p.000047: 8.6 Procedure and persons responsible for changes and audit trail.
p.000047: 8.7 Procedure for submission of data to sponsor? (hard disk, floppy disk, fax, modern network, mail, messenger)
p.000047: 8.8 Procedures for corrections (errors, omissions, etc.) in the data received and documentation
p.000047: 9.0. EXIT MEETING / INSPECTION REPORT
p.000047: At the post inspection meeting the inspectors would convey the findings of the inspection to the investigator and
p.000047: the representative of the pharmaceutical company or contract research organization and other key
p.000047: members of the study team. The inspection reports shall eventually reflect discussions had at the exit meeting
p.000047:
p.000047: The matters discussed at this meeting shall be in line with the report written by the inspectors. Important matters
p.000047: include:
p.000047: When significant violations of GCP are observed, reports shall contain sufficient narrative and accompanying
p.000047: documentation to support the findings. When it is apparent that the study has been conducted in substantial
p.000047: compliance with the guidelines, an abbreviated report may contain the following shall be compiled:
p.000047: 9.1 The comparison of raw data recorded in the case report forms to that of the source data, including the number
p.000047: of records compared and what was compared (patient charts, hospital records, lab slips and etc.)
p.000047: 9.2 A statement about the trial medication accountability records
p.000047: 9.3 A statement about protocol adherence, which should be characterized and quantified.
p.000047: 9.4 A statement about the obtaining of informed consent from each participant.
...
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document site visits by, and findings of, the X monitor
p.000047:
p.000047: To document any agreements or significant X X discussions regarding
p.000047: trial administration,
p.000047: protocol violations, trial conduct, adverse event (AE) reporting
p.000047:
p.000047: Page 44 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: - Notes of telephone calls
p.000047:
p.000047:
p.000047:
p.000047: 32.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 33.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 34.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 35.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 36.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 37.
p.000047: SIGNED INFORMED CONSENT FORMS
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SOURCE DOCUMENTS
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)
p.000047:
p.000047: DOCUMENTATION OF CRF CORRECTIONS
p.000047:
p.000047:
p.000047: NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS
p.000047:
p.000047: NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE,
p.000047: To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each
p.000047: subject in trial. Also to document direct access permission (see 3)
p.000047:
p.000047: To document the existence of the subject and substantiate integrity of trial data collected. To include original
p.000047: documents related to the trial, to medical treatment, and history of subject
p.000047:
p.000047: To document that the investigator or authorized member of the investigator’s staff confirms the observations recorded
p.000047:
p.000047: To document all changes/additions or corrections made to CRF after initial data were recorded
p.000047:
p.000047:
p.000047: Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with
p.000047: 3.4 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by Sponsor and/or Investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of
p.000047: unexpected serious adverse drug reactions and of other safety information in
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 45 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 38.
...
Social / Age
Searching for indicator age:
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p.000047: Guidelines are therefore addressed to investigators, pharmaceutical, manufacturers and other
p.000047: sponsors of research, drug regulatory authorities, the general public and all, those who have an interest in clinical
p.000047: trials research in Ghana.
p.000047:
p.000047: These Guidelines will support the regulatory requirements of the Food and Drugs Authority as stipulated in part 8, Act
p.000047: 851 of the Public Health Act 2012. It is therefore critical that research ethics committees, researchers, trial
p.000047: participants, principal investigators of trials and sponsors use these guidelines so as to ensure a standardized and
p.000047: ethical approach to clinical trial conducted in Ghana.
p.000047:
p.000047: The guidelines are also applicable to academic and contract clinical research and are intended to be applied during all
p.000047: stages of drug development including pre and post product registration and marketing, and they are also applicable, in
p.000047: whole or in part to biomedical research in general. They also provide a resource for editors to determine the
p.000047: acceptability of reported research for publication and specifically, on any study that could influence the use or the
p.000047: terms of registration of a pharmaceutical product.
p.000047: Page 4 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 2.0. GLOSSARY
p.000047: “Adult” A person who is eighteen (18) years of age or over that age.
p.000047:
p.000047:
p.000047: “Adverse Drug Reaction (ADR)” All noxious and unintended responses to a medicinal product related to any dose
p.000047: should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal
p.000047: relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the
p.000047: relationship cannot be ruled out.
p.000047: Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at
p.000047: doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of
p.000047: physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for
p.000047: Expedited Reporting).
p.000047:
p.000047: “Adverse Event (AE)” Any undesirable experience occurring to a subject during a clinical trial, whether or not
p.000047: considered related to the investigational product(s). An unexpected AE is an experience not reported in the
p.000047: current Investigators Brochure or elsewhere.
p.000047:
p.000047: “Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047:
p.000047: “Applicable Regulatory Requirement(s)” Any law(s) and regulation(s) addressing the conduct of clinical trials of
p.000047: investigational products.
p.000047:
p.000047: “Approval(s)” The affirmative decision of the appropriate institutions (FDA, IRB/IEC and GHS- EC) that the clinical
p.000047: trial has been reviewed and may be conducted at the institution site within the constraints set forth by the
...
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
...
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
...
Social / Child
Searching for indicator child:
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p.000047: “Audit Certificate” A declaration of confirmation by the auditor that an audit has taken place.
p.000047:
p.000047:
p.000047: “Audit Report” A written evaluation by the sponsor's auditor of the results of the audit.
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
...
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
p.000047: 7.1.2. The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000047: 7.1.3. A parent or legal representative of each child has given permission;
p.000047: 7.1.4. The agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and,
p.000047: 7.1.5. A child`s refusal to participate or continue in the research will be respected.
p.000047:
p.000047:
p.000047: 7.2. Research involving individuals who are cognitively impaired subjects by reason of mental or
p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
...
Searching for indicator children:
(return to top)
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
p.000047: Form, this is defined as the date when the clinical trial site shall start to enroll participants in the clinical
p.000047: trial.
p.000047:
...
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
p.000047: protocol, investigators brochure, patient consent forms, insurance for participants, current CV’s for
p.000047: investigators and literature detailing rationale for the study and any other documents that the IRB/ICE
p.000047: may need to fulfill its responsibilities.
p.000047: 3.1.5. The Ethics Committee shall consider the following:
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
p.000047: 3.1.5.2. The suitability of the protocol in relation to the objectives of the study. Its scientific efficiency
...
p.000047: of a GCP inspection.
p.000047: 6.5. During an inspection, inspectors:
p.000047: 6.5.1. Should be given easy access to the trial sites and laboratories at all times
p.000047: 6.5.2. Should have easy access to all patient files and raw data utilised for and generated during
p.000047: the trial. All site data and documents including participant files must be available for verification.
p.000047: 6.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that
p.000047: the conclusions that would be presented are derived correctly from the raw data.
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
p.000047: 7.1.2. The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000047: 7.1.3. A parent or legal representative of each child has given permission;
p.000047: 7.1.4. The agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and,
p.000047: 7.1.5. A child`s refusal to participate or continue in the research will be respected.
p.000047:
p.000047:
p.000047: 7.2. Research involving individuals who are cognitively impaired subjects by reason of mental or
p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
p.000047: 1.1. The phase of the clinical trial
p.000047: 1.2. The nature of the investigational product.
p.000047: 1.3. The market authorization status of the investigational product
p.000047: 1.4. The population under study
p.000047: 1.5. Capacity of trial site
p.000047: 1.6. Previous experience of FDA with sponsor/principal investigator with respect to compliance to GCP
p.000047: requirements.
p.000047:
p.000047: 2.0. WHAT DOES AN INSPECTION INVOLVE?
p.000047: The inspection may involve:
p.000047: 2.1. A comparison of the practices and procedures of the clinical investigator with the commitments made in the
p.000047: application to conduct a clinical trial;
p.000047: 2.2. A comparison of the data submitted to the authority with the source data; and/or
p.000047: 2.3. A system inspection of the sponsor, clinical laboratory or CRO generating data for submission to
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000047: 5.13. Whether clinical laboratory testing (including ecgs x-rays and other special investigations), as noted
p.000047: in the case reports, can't be evaluated by the presence of completed laboratory reports in the source documents.
p.000047: 5.14. The occurrence of adverse reactions would be determined. The reporting of these events to FDA and the Ethics
p.000047: Committee shall be documented.
p.000047: 5.15. All persons obtaining raw data or involved in the collection or analysis of such data would be identified.
p.000047:
p.000047: 6.0. TRIAL MEDICATION
p.000047: With regard to trial medication the following are considered as important in an inspection:
p.000047: 6.1. Determination of accounting procedures for the test and comparator drugs.
p.000047: 6.2. Dates and quantity of trial medication dispensed as well as the recipients must be available as well as
p.000047: corroboration by raw data notations.
p.000047: 6.3. The blinding of medication, if appropriate, must be validated to ensure protection of the study from bias.
p.000047:
p.000047: Page 32 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.4. It shall be determined whether distribution of the article was limited to those persons under the
p.000047: investigator's direct supervision.
p.000047: 6.5. The storage area may be inspected.
p.000047: 6.6. It would be determined whether the test article is a controlled substance and whether it is securely
p.000047: locked
p.000047: 6.7. Access to the controlled substance must be restricted to the investigator and the responsible pharmacist.
p.000047:
p.000047: 7.0. LABORATORY
p.000047: The FDA during an inspection would determine the systems and procedures that are followed within an organization that
p.000047: is conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice
p.000047: (GCP).
p.000047:
p.000047: Inspections of a laboratory being used to analyze samples from a clinical trial shall be in accordance
p.000047: with provisions outlined in the Good Clinical Laboratory Practice Guidelines published by WHO/TDR.
p.000047:
p.000047: 7.1 Transfer of Biological Samples
p.000047: No person shall make arrangements to receive or ship biological samples from a clinical trial without
p.000047: prior approval from the Authority.
p.000047:
p.000047: Persons who wish to import or export any biological samples from a clinical trial shall submit an application and a
p.000047: suitable Material Transfer Agreement for approval by the Authority. The application must be accompanied
p.000047: with the appropriate clearance from a reputable Ethics Committee or Institutional Review Board in Ghana.
p.000047:
p.000047:
p.000047: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS
p.000047: If electronic data systems are involved in gathering data, storing data, or transmitting data to the sponsor, these
p.000047: would be identified and their capabilities established. The following are important:
p.000047: 8.1 The source of data entered into the computer
p.000047:
p.000047: Page 33 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 8.2 The qualification of the personnel to enter data
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000047: considered related to the investigational product(s). An unexpected AE is an experience not reported in the
p.000047: current Investigators Brochure or elsewhere.
p.000047:
p.000047: “Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047:
p.000047: “Applicable Regulatory Requirement(s)” Any law(s) and regulation(s) addressing the conduct of clinical trials of
p.000047: investigational products.
p.000047:
p.000047: “Approval(s)” The affirmative decision of the appropriate institutions (FDA, IRB/IEC and GHS- EC) that the clinical
p.000047: trial has been reviewed and may be conducted at the institution site within the constraints set forth by the
p.000047: appropriate institutions, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000047:
p.000047: “Audit Certificate” A declaration of confirmation by the auditor that an audit has taken place.
p.000047:
p.000047:
p.000047: “Audit Report” A written evaluation by the sponsor's auditor of the results of the audit.
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
p.000047: 1.1. The phase of the clinical trial
p.000047: 1.2. The nature of the investigational product.
...
Social / Women
Searching for indicator women:
(return to top)
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
p.000047: 3.1.2. A legal professional
p.000047: 3.1.3. A consumer representative who is independent of the institution/trial site.
p.000047: Only those members who are independent of the investigator/sponsor of the trial should make decisions.
p.000047: 3.1.4. The Ethics Committee should obtain all the information relating to the trial including,
p.000047: protocol, investigators brochure, patient consent forms, insurance for participants, current CV’s for
p.000047: investigators and literature detailing rationale for the study and any other documents that the IRB/ICE
p.000047: may need to fulfill its responsibilities.
p.000047: 3.1.5. The Ethics Committee shall consider the following:
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
...
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
p.000047: 7.2.3. The consent of each subject has been obtained to the extent of that person's capabilities, and a
p.000047: prospective subject's refusal to participate in research is always respected, unless, in exceptional
p.000047: circumstances, there is no reasonable medical alternative and local law permits overriding the objection; and,
p.000047: 7.2.4. In cases where prospective subjects lack capacity to consent, permission is obtained from a
p.000047: responsible family member or a legally authorized representative in accordance with applicable law.
p.000047:
p.000047: 7.3. Pregnant women as research participants:
p.000047: 7.3.1. Investigators, sponsors or ethical review committees should not exclude women of reproductive age
p.000047: from biomedical research.
p.000047: 7.3.2. Pregnant women should be presumed to be eligible for participation in biomedical research.
p.000047: 7.3.3. The potential for becoming pregnant during a study should not, in itself, be used as a reason for
p.000047: precluding or limiting participation. However, a thorough discussion of risks to the pregnant woman and to her
p.000047: foetus is a prerequisite for the woman’s ability to make a rational decision to enroll in a clinical study.
p.000047: 7.3.4. In this discussion, if participation in the research might be hazardous to a foetus or a woman
p.000047: if she becomes pregnant, the sponsors/ investigators should guarantee the prospective subject a pregnancy
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
p.000047: 1.1. The phase of the clinical trial
p.000047: 1.2. The nature of the investigational product.
p.000047: 1.3. The market authorization status of the investigational product
p.000047: 1.4. The population under study
p.000047: 1.5. Capacity of trial site
p.000047: 1.6. Previous experience of FDA with sponsor/principal investigator with respect to compliance to GCP
p.000047: requirements.
p.000047:
p.000047: 2.0. WHAT DOES AN INSPECTION INVOLVE?
p.000047: The inspection may involve:
p.000047: 2.1. A comparison of the practices and procedures of the clinical investigator with the commitments made in the
p.000047: application to conduct a clinical trial;
p.000047: 2.2. A comparison of the data submitted to the authority with the source data; and/or
p.000047: 2.3. A system inspection of the sponsor, clinical laboratory or CRO generating data for submission to
p.000047: regulatory authorities. This may include inspection of both the clinical facility and analytical facility.
p.000047:
p.000047: 3.0. THE INSPECTION
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000047:
p.000047:
p.000047: “Audit Report” A written evaluation by the sponsor's auditor of the results of the audit.
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
...
Social / education
Searching for indicator education:
(return to top)
p.000047: i.e. the potential for reaching sound conclusions with the smallest possible exposure of subjects,
p.000047: and the justification of predictable risks and inconveniences weighed against the anticipated
p.000047: benefits for the subjects and/or others.
p.000047: 3.1.5.3. The adequacy and completeness of the written information to be given to the subjects, their relatives,
p.000047: guardians and, if necessary legal representatives.
p.000047:
p.000047: Page 10 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.1.5.4. The means by which initial recruitment is to be conducted and by which full information is to be
p.000047: given, and by which consent is to be obtained. All written information for the subject and/or legal
p.000047: representative must be submitted in its final form.
p.000047: 3.1.5.5. Provision for compensation/treatment in the case of injury or death of a subject if
p.000047: attributed to a clinical trial, and any insurance or indemnity to cover the liability of the investigator and
p.000047: sponsor.
p.000047: 3.1.5.6. The extent to which investigators and subjects may be
p.000047: rewarded/compensated for participation.
p.000047: 3.1.6. The Ethics Committee shall give its opinion and advice in writing clearly identifying the trial, the
p.000047: documents reviewed and the dates of review.
p.000047:
p.000047: 3.2. INVESTIGATOR
p.000047:
p.000047: Investigators shall satisfy the following:
p.000047: 3.2.1. The Investigator should be qualified by education, training and experience to assume responsibility
p.000047: for the proper conduct of the trial and should provide evidence of such qualifications and experience
p.000047: through an up to date Curriculum Vitae. The Principal Investigator’s qualification should be in accordance with
p.000047: Section 16.2.3 under the FDA’s Guidelines for Conducting Clinical Trials.
p.000047: 3.2.2. The Investigator should be thoroughly familiar with the characteristics and appropriate use of the
p.000047: investigational product as described in the protocol, current investigator’s brochure, in the product
p.000047: information and in other information sources.
p.000047: 3.2.3. Have a clear understanding and willingness to obey the ethical and legal requirements of the trial.
p.000047: 3.2.4. To permit monitoring and auditing of the trial and inspection by the FDA or appointed representatives.
p.000047: 3.2.5. Keep a list of appropriately qualified persons to whom the Investigator has delegated significant
p.000047: trial-related duties.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 11 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.2.6. The Principal Investigator shall ensure that all members of the study team have evidence of GCP training of
p.000047: not more than 2 years. GCP certificates shall be required for key members of the team.
p.000047: 3.2.7. The Investigator should not have been found guilty of any misconduct under the Ghana Medical and Dental
p.000047: Decree.
p.000047: 3.2.8. The Principal Investigator must be an appropriately qualified and competent person having practical
p.000047: experience within the relevant professional area, who is resident in the country and who is responsible for the
...
Social / parents
Searching for indicator parent:
(return to top)
p.000047: 6.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that
p.000047: the conclusions that would be presented are derived correctly from the raw data.
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
p.000047: 7.1. Research involving children (including infants).
p.000047: Before undertaking research involving children, the investigator must ensure that:
p.000047: 7.1.1. The research might not equally well be carried out with adults;
p.000047: 7.1.2. The purpose of the research is to obtain knowledge relevant to the health needs of children;
p.000047: 7.1.3. A parent or legal representative of each child has given permission;
p.000047: 7.1.4. The agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and,
p.000047: 7.1.5. A child`s refusal to participate or continue in the research will be respected.
p.000047:
p.000047:
p.000047: 7.2. Research involving individuals who are cognitively impaired subjects by reason of mental or
p.000047: behavioral disorders are not capable of giving adequately informed consent.
p.000047: Before undertaking research involving individuals who by reason of mental or behavioral disorders are not
p.000047: capable of giving adequately informed consent, the investigator must ensure that:
p.000047: 7.2.1. Such persons will not be subjects of research that might equally well be carried out on persons whose
p.000047: capacity to give adequately informed consent is not impaired;
p.000047:
p.000047:
p.000047: Page 26 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.2.2. The purpose of the research is to obtain knowledge relevant to the particular health needs of
p.000047: persons with mental or behavioral disorders;
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000047: 3.1.5.1. The suitability of the investigator for the proposed trial in relation to his/her qualifications,
p.000047: experience, supporting staff, and available facilities, on basis of the information available to the Committee.
p.000047: 3.1.5.2. The suitability of the protocol in relation to the objectives of the study. Its scientific efficiency
p.000047: i.e. the potential for reaching sound conclusions with the smallest possible exposure of subjects,
p.000047: and the justification of predictable risks and inconveniences weighed against the anticipated
p.000047: benefits for the subjects and/or others.
p.000047: 3.1.5.3. The adequacy and completeness of the written information to be given to the subjects, their relatives,
p.000047: guardians and, if necessary legal representatives.
p.000047:
p.000047: Page 10 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.1.5.4. The means by which initial recruitment is to be conducted and by which full information is to be
p.000047: given, and by which consent is to be obtained. All written information for the subject and/or legal
p.000047: representative must be submitted in its final form.
p.000047: 3.1.5.5. Provision for compensation/treatment in the case of injury or death of a subject if
p.000047: attributed to a clinical trial, and any insurance or indemnity to cover the liability of the investigator and
p.000047: sponsor.
p.000047: 3.1.5.6. The extent to which investigators and subjects may be
p.000047: rewarded/compensated for participation.
p.000047: 3.1.6. The Ethics Committee shall give its opinion and advice in writing clearly identifying the trial, the
p.000047: documents reviewed and the dates of review.
p.000047:
p.000047: 3.2. INVESTIGATOR
p.000047:
p.000047: Investigators shall satisfy the following:
p.000047: 3.2.1. The Investigator should be qualified by education, training and experience to assume responsibility
p.000047: for the proper conduct of the trial and should provide evidence of such qualifications and experience
p.000047: through an up to date Curriculum Vitae. The Principal Investigator’s qualification should be in accordance with
p.000047: Section 16.2.3 under the FDA’s Guidelines for Conducting Clinical Trials.
p.000047: 3.2.2. The Investigator should be thoroughly familiar with the characteristics and appropriate use of the
p.000047: investigational product as described in the protocol, current investigator’s brochure, in the product
p.000047: information and in other information sources.
p.000047: 3.2.3. Have a clear understanding and willingness to obey the ethical and legal requirements of the trial.
p.000047: 3.2.4. To permit monitoring and auditing of the trial and inspection by the FDA or appointed representatives.
p.000047: 3.2.5. Keep a list of appropriately qualified persons to whom the Investigator has delegated significant
p.000047: trial-related duties.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 11 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.2.6. The Principal Investigator shall ensure that all members of the study team have evidence of GCP training of
p.000047: not more than 2 years. GCP certificates shall be required for key members of the team.
p.000047: 3.2.7. The Investigator should not have been found guilty of any misconduct under the Ghana Medical and Dental
...
p.000047:
p.000047: DATED, DOCUMENTED
p.000047: To document that subjects will be given appropriate written information (content and wording) to support their ability
p.000047: to give fully informed consent
p.000047:
p.000047: To document that recruitment measures are appropriate and not coercive
p.000047:
p.000047:
p.000047: To document the financial agreement between the investigator/institution and the sponsor for the trial
p.000047:
p.000047: To document that compensation to subject(s) for trial-related injury will be available
p.000047:
p.000047:
p.000047: To document agreements
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that the trial has been subject to
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: X
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: Page 37 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: APPROVAL/FAVOURA BLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000047: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000047: - Protocol and any amendments
p.000047: - CRF (if applicable)
p.000047: - Informed consent form(s)
p.000047: - Any other written information to be provided to the subject(s)
p.000047: - Advertisement for subject recruitment used)
p.000047: - Subject compensation (if any)
p.000047: - Any other documents given approval/ favourable opinion
p.000047: IRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)
p.000047:
p.000047:
p.000047: 8. INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE COMPOSITION
p.000047:
p.000047: 9. REGULATORY AUTHORITY(IES)
p.000047: To document that the IRB/IEC is constituted in agreement with GCP
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document appropriate authorization /approval
p.000047: /notification by the regulatory authority(ies) has
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 38 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: AUTHORISATION/ APPROVAL/ NOTIFICATION OF PROTOCOL
p.000047: (where required)
p.000047: been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)
p.000047:
p.000047:
p.000047:
p.000047: 10.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 11.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 12.
p.000047: CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB- INVESTIGATOR(S)
p.000047:
p.000047: NORMAL VALUE(S)
p.000047: /RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL
p.000047:
p.000047: MEDICAL/ LABORATORY/ TECHNICAL PROCEDURES /TESTS -
p.000047: Certification or
...
p.000047: combined with 19)
p.000047: X X
p.000047: (a third party if applicable)
p.000047:
p.000047:
p.000047: X
p.000047: (a third party if applicable)
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: 3.0. During the Clinical Conduct of the Trial
p.000047: In addition to having on file the above documents, the following should be added to the files during the trial as
p.000047: evidence that all new relevant information is documented as it becomes available
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of
p.000047: Investigator /Sponsor Sp
p.000047: or
p.000047:
p.000047:
p.000047: 21.
p.000047: INVESTIGATOR’S BROCHURE UPDATES
p.000047: To document that investigator is informed in a X X timely manner of
p.000047: relevant information as it
p.000047: becomes available
p.000047:
p.000047:
p.000047: Page 41 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 22.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 23.
p.000047: ANY REVISION TO:
p.000047: - Protocol/amendment(s) and CRF
p.000047: - Informed consent form any other written
p.000047: - Information provided to subjects
p.000047: - Advertisement for subject recruitment
p.000047: (if used)
p.000047:
p.000047:
p.000047: DATED, DOCUMENTED APPROVAL/ FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000047: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000047: -Protocol amendment(s)
p.000047: -Revision(s) of:
p.000047: - informed consent form
p.000047: - any other written information to be provided to the subject
p.000047: - advertisement for subject recruitment if used)
p.000047: -Any other documents given approval/favourable opinion
p.000047:
p.000047:
p.000047: To document revisions of these trial related X X documents that take
p.000047: effect during trial
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that the amendment(s) and/or X X revision(s) have been
p.000047: subject to IRB/IEC review
p.000047: and were given approval/favourable opinion. To identify the version number and date of the document(s).
p.000047: Page 42 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: -Continuing review of trial (where required)
p.000047:
p.000047:
p.000047: 24.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 25.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 26.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 27.
p.000047: REGULATORY AUTHORITY(IES) AUTHORISATIONS/ APPROVALS/ NOTIFICATIONS WHERE REQUIRED FOR:
p.000047: - Protocol amendment(s) and other documents
p.000047:
p.000047: CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB- INVESTIGATOR(S)
p.000047:
p.000047: UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S
p.000047: ) INCLUDED IN THE PROTOCOL
p.000047:
p.000047: UPDATES OF MEDICAL/LABORATO RY/ TECHNICAL
p.000047: To document compliance with applicable regulatory requirements
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: (see 10)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document normal values and ranges that are revised during the trial (see 11)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that tests remain adequate throughout the trial period (see 12)
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 45 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 38.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 39.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 40.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 41.
p.000047: TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY
p.000047: INFORMATION NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
p.000047:
p.000047:
p.000047: INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SUBJECT SCREENING LOG
p.000047:
p.000047:
p.000047: SUBJECT IDENTIFICATION CODE LIST
p.000047: accordance with 3.3.14 and 3.2.12.8 of FDA Guidelines for GCP in Ghana and 3.4 of FDA Guidelines for Conducting
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by sponsor to investigators of safety information of findings that could affect adversely
p.000047: the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable
p.000047: opinion to continue the trial.
p.000047:
p.000047:
p.000047: Interim or annual reports provided to IRB/IEC in accordance with approving IRB/IEC requirements and to authority(ies)
p.000047: in accordance with 3.5.1.2 and 3.5.1.3 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047: To document identification of subjects who entered pre-trial screening
p.000047:
p.000047:
p.000047: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers
p.000047: on enrolling in the trial. Allows
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047:
p.000047: X
p.000047:
p.000047: Page 46 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 42.
p.000047:
p.000047:
p.000047:
p.000047: 43.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 44.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 45.
p.000047:
p.000047:
p.000047:
p.000047: SUBJECT ENROLMENT LOG
p.000047:
p.000047: INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE
p.000047: SIGNATURE SHEET
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)
p.000047: investigator/institution to reveal identity of any subject
p.000047: X
...
General/Other / Incapacitated
Searching for indicator incapacity:
(return to top)
p.000047:
p.000047: “Lot Release Certificate (LRC)” An official document that authorizes the manufacturer to release a specific
p.000047: lot of a product.
p.000047:
p.000047:
p.000047: Page 8 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Medical Device” As defined in Part Seven, Section 149 of the Public Health Act 2012, Act 851.
p.000047:
p.000047:
p.000047: “Placebo” A medication with no active ingredients or a procedure without any medical benefit.
p.000047:
p.000047:
p.000047: “Principal Investigator / Investigator” The person responsible for the conduct of the clinical trial at the clinical
p.000047: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000047: located.
p.000047:
p.000047: “Protocol Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047: “Protocol” A document that describes the objective(s), design, methodology, statistical
p.000047: considerations and the organization of a trial. The protocol usually also gives the background and rationale for the
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
p.000047: “Vulnerable population” An individual whose willingness to volunteer in a clinical trial may be unduly influenced by
p.000047: the expectations, whether justified or not, of benefits associated with
p.000047:
p.000047:
p.000047: Page 9 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
p.000047: Examples are pregnant women, cognitively impaired subjects, children and prisoners.
p.000047:
p.000047:
p.000047:
p.000047: 3.0. RESPONSIBILITIES
p.000047:
p.000047: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
p.000047: The Ethics Committee should consist of:
p.000047: 3.1.1. At least 3 professionals in the medical and scientific field with sufficient qualifications and
p.000047: experience.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000047: items:
p.000047: 3.3.5.1. The conduct of the trial in compliance with Good Clinical Practices and with the approved protocol; and
p.000047: to be in compliance with procedures for data recording/reporting and to permit monitoring, auditing
p.000047: and inspection according to the protocol.
p.000047: 3.3.5.2. The Sponsor and all investigators shall sign and date the protocol of the trial to confirm the agreement.
p.000047: 3.3.6. The Sponsor shall ensure that sufficient safety and efficacy data from non-clinical studies and/or
p.000047: clinical trials are available to support human exposure by the route, at the dosages for the duration and in the trial
p.000047: population to be studied.
p.000047: 3.3.7. The Sponsor shall ensure that the IP’s (including active comparator(s) and placebo) is manufactured in
p.000047: accordance with Good Manufacturing Practices and are adequately packed and labelled in a manner that protects the
p.000047: blinding if applicable. In addition
p.000047:
p.000047:
p.000047: Page 15 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: the labelling should comply with the regulatory requirements (refer to FDA’s Guidelines for Labeling of
p.000047: Products).
p.000047: 3.3.8. The Sponsor shall determine for the IP’s, acceptable storage temperature and conditions, storage
p.000047: times, reconstitution fluids and procedures and devices for product infusion if any.
p.000047: 3.3.9. In blinded trials, the coding system for the IP’s shall include a mechanism that permits rapid
p.000047: identification of the products in case of a medical emergency but does not permit undetectable breaks of the blinding.
p.000047: 3.3.10. If formulation changes are made to the IP or comparator products during the course of the clinical
p.000047: development, the results of pharmaceutical and pharmacokinetic profile of the product shall be made available to the
p.000047: FDA prior to the use of the reformulated IP in clinical trials.
p.000047: 3.3.11. The Sponsor shall appoint qualified and suitable trained individuals to monitor the trial.
p.000047: 3.3.12. The Sponsor should provide insurance cover for all trial subjects. The Sponsor’s policies and
p.000047: procedures should address the costs of treatment of trial subjects in the event of trial-related injuries.
p.000047: 3.3.13. The financial aspects of the trial should be documented in an agreement between the Sponsor and the
p.000047: Investigator/institution.
p.000047: 3.3.14. The Sponsor should report to the FDA and all relevant institutions, all adverse events occurring during
p.000047: the course of the trial. The Sponsor should expedite reporting all serious adverse events to the Ethics
p.000047: Committee, the FDA and the Sponsor and the Investigators should immediately undertake appropriate and necessary
p.000047: measures and treatment to protect the trial subjects. (Refer to Guidelines for the Conduct of Clinical Trials for
p.000047: timelines).
p.000047: 3.3.15. When a trial is prematurely terminated or suspended by the Sponsor/Investigators, the FDA and Ethics
p.000047: Committee and should be informed of the decision to terminate/suspend the trial and the reasons
...
p.000047: have been adequately informed of their responsibilities.
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.3.6. To determine if the Authority’s and Ethics Committee and other relevant approvals has been
p.000047: obtained with stipulated conditions adhered to.
p.000047: 3.3.7. To determine in what manner the investigational products are handled and stored, and that investigational
p.000047: products are dispensed to study participants in accordance with the protocol and that any unused products are
p.000047: returned to the Sponsor. Reconciliation of trial medication must be provided.
p.000047: 3.3.8. To ensure that the confidentiality of all information about participants is respected (by all persons
p.000047: involved).
p.000047: 3.3.9. To ensure that the investigator observes the following points particularly related to medical care:
p.000047: In addition, the investigator needs to provide retrospective data on numbers of participants who would have satisfied
p.000047: the proposed entrance criteria during preceding time periods in order to assure an adequate recruitment rate
p.000047: for the study. The investigator also needs to provide an up- to-date curriculum vita.
p.000047:
p.000047: The Investigator is medically responsible for those participants who are under his/her care for the duration of the
p.000047: study and must ensure that appropriate medical care is maintained after the study. Where appropriate, fully functional
p.000047: resuscitation equipment should be immediately available in case of emergency. Clinical significant abnormal laboratory
p.000047: values or clinical observations must be followed up after completion of the study.
p.000047:
p.000047: 4.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
p.000047: Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial
p.000047: and the quality of the data produced. These documents in addition to other functions not herein mentioned serve to
p.000047: demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical
p.000047: Practice and with all applicable regulatory requirements.
p.000047: The minimum list of essential documents which has been developed are outlined below. The various documents
p.000047: are grouped in three sections according to the stage of the trial during which they will normally be generated (Refer
p.000047: to Apppendix II for more details):
p.000047:
p.000047: Page 30 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 4.1. Before the clinical phase of the trial commences,
p.000047: 4.2. During the clinical conduct of the trial, and
p.000047: 4.3. After completion or termination of the trial.
p.000047: A description is given of the purpose of each document, and whether it should be filed in either the
p.000047: investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents,
p.000047: provided the individual elements are readily identifiable.
p.000047: Trial master files should be established at the beginning of the trial, both at the
p.000047: investigator/institution's site and at the sponsor's office. A final close-out of a trial can only be done when the
...
p.000047:
p.000047:
p.000047: CERTIFICATE(S) OF ANALYSIS OF
p.000047: To document compliance with applicable X labelling regulations and
p.000047: appropriateness of
p.000047: instructions provided to the subjects
p.000047:
p.000047:
p.000047:
p.000047: To document instructions needed to ensure proper X X storage, packaging,
p.000047: dispensing and disposition of
p.000047: investigational products and trial-related materials
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document shipment dates, batch numbers and X X method of shipment of
p.000047: investigational product(s)
p.000047: and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document identity, purity, and strength of X investigational
p.000047: product(s) to be used in the trial
p.000047: Page 40 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: INVESTIGATIONAL PRODUCT(S) SHIPPED
p.000047:
p.000047:
p.000047: 17.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 18.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 19.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 20.
p.000047: DECODING PROCEDURES FOR BLINDED TRIALS
p.000047:
p.000047:
p.000047: MASTER RANDOMISATION LIST
p.000047:
p.000047: PRE-TRIAL MONITORING REPORT
p.000047:
p.000047:
p.000047: TRIAL INITIATION MONITORING REPORT
p.000047: To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking
p.000047: the blind for the remaining subjects' treatment
p.000047:
p.000047: To document method for randomization of trial population
p.000047:
p.000047:
p.000047: To document that the site is suitable for the trial (may be combined with 20)
p.000047:
p.000047:
p.000047: To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be
p.000047: combined with 19)
p.000047: X X
p.000047: (a third party if applicable)
p.000047:
p.000047:
p.000047: X
p.000047: (a third party if applicable)
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: 3.0. During the Clinical Conduct of the Trial
p.000047: In addition to having on file the above documents, the following should be added to the files during the trial as
p.000047: evidence that all new relevant information is documented as it becomes available
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of
p.000047: Investigator /Sponsor Sp
p.000047: or
p.000047:
p.000047:
p.000047: 21.
p.000047: INVESTIGATOR’S BROCHURE UPDATES
p.000047: To document that investigator is informed in a X X timely manner of
p.000047: relevant information as it
p.000047: becomes available
p.000047:
p.000047:
p.000047: Page 41 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 22.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: FOOD AND DRUGS AUTHORITY
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: GUIDELINES FOR GOOD CLINICAL PRACTICE IN GHANA
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Document No. : FDA/SMC/CTD/GL-GCP/2013/02
p.000004: Date of First Adoption : 1st February, 2013
p.000004: Date of Issue : 1st March, 2013
p.000004: Version No. 01
p.000004:
p.000004: FDA/SMC/CTD/GL-GCP/2013/02
p.000004: TABLE OF CONTENTS
p.000004: 1.0. INTRODUCTION
p.000004: 4
p.000004: 2.0. GLOSSARY
p.000005: 5
p.000005: 3.0. RESPONSIBILITIES
p.000005: 5
p.000005: 3.1. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 10
p.000005: 3.2. INVESTIGATOR
p.000011: 11
p.000011: 3.3. SPONSOR
p.000014: 14
p.000014: 4.0. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
p.000018: 18
p.000018: 4.1. General Information
p.000018: 18
p.000018: 4.2. Background Information
p.000018: 18
p.000018: 4.3. Trial Objectives and Purpose
p.000019: 19
p.000019: 4.4. Trial Design
p.000019: 19
p.000019: 4.5. Selection and Withdrawal of Subjects
p.000020: 20
p.000020: 4.6. Treatment of Subjects
p.000021: 21
p.000021: 4.7. Assessment of Efficacy
p.000021: 21
p.000021: 4.8. Assessment of Safety
p.000021: 21
p.000021: 4.9. Statistics
p.000022: 22
p.000022: 4.10. Direct Access to Source Data/Documents
p.000022: 22
p.000022: 4.11. Quality Control and Quality Assurance
p.000022: 22
p.000022: 4.12. Ethics
p.000023: 23
p.000023: 4.13. Data Handling and Record Keeping
p.000023: 23
p.000023: 4.14. Financing and Insurance
p.000023: 23
p.000023: 4.15. Publication Policy
p.000023: 23
p.000023: 5.0. INVESTIGATOR’S BROCHURE
p.000024: 24
p.000024: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000024: 24
p.000024: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POULATIONS
p.000026: 26
p.000026: APPENDIX I
p.000028: 28
p.000028: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY 28
p.000028: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION 28
p.000028: 2.0. WHAT DOES AN INSPECTION INVOLVE? 28
p.000028: 3.0. THE INSPECTION
p.000028: 28
p.000028: 4.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 30
p.000028: 5.0. TRIAL PROCEDURES
p.000031: 31
p.000031: Page 2 of 48
p.000031:
p.000031: FDA/SMC/CTD/GL-GCP/2013/02
p.000031: 6.0. TRIAL MEDICATION
p.000032: 32
p.000032: 7.0. LABORATORY
p.000033: 33
p.000033: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS 33
p.000033: 9.0. EXIT MEETING / INSPECTION REPORT
p.000034: 34
p.000034: APPENDIX II
p.000035: 35
p.000035: ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 35
p.000035: 1.0. Introduction
p.000035: 35
p.000035: 2.0. Before the Clinical Phase of the Trial Commences
p.000036: 36
p.000036: 3.0. During the Clinical Conduct of the Trial
p.000041: 41
p.000041: 4.0. After Completion or Termination of the Trial
p.000047: 47
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 3 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 1.0. INTRODUCTION
p.000047: The purpose of these guidelines is to provide investigators conducting clinical trials in Ghana with clear
p.000047: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Ghana are
p.000047: designed and conducted according to sound scientific and ethical standards within the framework of good
p.000047: clinical practice. Compliance with these standards provides the public with assurance that the rights, safety and
p.000047: wellbeing of trial participants are protected and that clinical trial data are credible.
p.000047:
p.000047: The guidelines were partly derived from the International Conference on Harmonization Good Clinical Practice (ICH
p.000047: GCP) and from the International Ethical Guidelines for Biomedical Research involving human subjects prepared by
p.000047: the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with World Health Organization
p.000047: (WHO 2002).
p.000047:
p.000047: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical
p.000047: investigators, industry/sponsors/monitors, institutions/ethics committees, and government regulators. The
p.000047: Guidelines are therefore addressed to investigators, pharmaceutical, manufacturers and other
p.000047: sponsors of research, drug regulatory authorities, the general public and all, those who have an interest in clinical
p.000047: trials research in Ghana.
p.000047:
p.000047: These Guidelines will support the regulatory requirements of the Food and Drugs Authority as stipulated in part 8, Act
p.000047: 851 of the Public Health Act 2012. It is therefore critical that research ethics committees, researchers, trial
p.000047: participants, principal investigators of trials and sponsors use these guidelines so as to ensure a standardized and
p.000047: ethical approach to clinical trial conducted in Ghana.
p.000047:
p.000047: The guidelines are also applicable to academic and contract clinical research and are intended to be applied during all
p.000047: stages of drug development including pre and post product registration and marketing, and they are also applicable, in
p.000047: whole or in part to biomedical research in general. They also provide a resource for editors to determine the
p.000047: acceptability of reported research for publication and specifically, on any study that could influence the use or the
p.000047: terms of registration of a pharmaceutical product.
p.000047: Page 4 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 2.0. GLOSSARY
p.000047: “Adult” A person who is eighteen (18) years of age or over that age.
p.000047:
p.000047:
p.000047: “Adverse Drug Reaction (ADR)” All noxious and unintended responses to a medicinal product related to any dose
p.000047: should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal
p.000047: relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the
p.000047: relationship cannot be ruled out.
...
p.000047: appropriate institutions, Good Clinical Practice (GCP), and the applicable regulatory requirements.
p.000047:
p.000047: “Audit Certificate” A declaration of confirmation by the auditor that an audit has taken place.
p.000047:
p.000047:
p.000047: “Audit Report” A written evaluation by the sponsor's auditor of the results of the audit.
p.000047:
p.000047:
p.000047: “Audit Trail” Documentation that allows reconstruction of the course of events.
p.000047: Page 5 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Audit” A systematic and independent examination of trial related activities and documents to determine whether the
p.000047: evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately
p.000047: reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice
p.000047: (GCP), and the applicable regulatory requirement(s).
p.000047:
p.000047: “Blinding/Masking” A procedure in which one or more parties to the trial are kept unaware of the treatment
p.000047: assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to
p.000047: the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment
p.000047: assignment(s).
p.000047:
p.000047: “Case Report Form” A printed, optical or electronic document designed to record all of the protocol
p.000047: required information. There should be assurance of accurate input and presentation and it should allow verification.
p.000047:
p.000047: “Certificate of Analysis (COA)” An authenticated document issued by an appropriate authority that certifies the quality
p.000047: and purity of pharmaceuticals, and animal and plant products.
p.000047:
p.000047: “Child/Minor” A person who is below eighteen (18) years of age or the definition of child as defined in the current
p.000047: Children’s Act of Ghana.
p.000047:
p.000047: “Clinical Trial Site” The location(s) where trial-related activities are actually conducted.
p.000047:
p.000047:
p.000047: “Clinical Trial” means an investigation consisting of a particular description by, or under the direction of a medical
p.000047: practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical
p.000047: device or procedure or herbal medicinal product of that description has effects which may be beneficial to and safe to
p.000047: the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose
p.000047: of ascertaining beneficial or harmful effects.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 6 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Clinical Trials Technical Advisory Committee (CT-TAC)” As established by Section 150 of the Public Health Act 2012,
p.000047: Act 851.
p.000047:
p.000047: “Contract Research Organization (CRO)” A scientific body (commercial or academic) contracted by a
p.000047: Sponsor to perform some of the Sponsors trial related duties and function
p.000047:
p.000047: “Data Safety Monitoring Board (DSMB)” An independent data-monitoring committee that may be established by the Sponsor
p.000047: to assess at intervals the progress of a clinical, the safety data, and the critical efficacy endpoints, and to
p.000047: recommend to the Sponsor whether to continue, modify, or stop a trial.
p.000047:
p.000047: “Date of Commencement” For the purpose of the Clinical Trial Certificate and Quarterly Progress Report
p.000047: Form, this is defined as the date when the clinical trial site shall start to enroll participants in the clinical
p.000047: trial.
p.000047:
p.000047: “Drug/Medicine” Includes
p.000047: 1 A substance referred to in a publication mentioned in the Fourth Schedule,
p.000047: 2 A substance or mixture of substances prepared, sold or represented for use in
p.000047: i. Restoring, correcting or modifying organic functions in man or animal, and
p.000047: ii. The diagnosis, treatment, mitigation or prevention of disease, disorder of abnormal, physical
p.000047: state or the symptoms of it, in man or animal, or
p.000047: 3 Nutritional supplements
p.000047:
p.000047:
p.000047: “FDA” means Food and Drugs Authority
p.000047:
p.000047:
p.000047: “Good Clinical Practice (GCP) Inspection” The act by the FDA of conducting an official review of
p.000047: documents, facilities, records and any other resources that are deemed to be related to the clinical trial and that may
p.000047: be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at
p.000047: other establishments deemed appropriate by the FDA.
p.000047:
p.000047:
p.000047: Page 7 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: “Good Manufacturing Practice (GMP)” The part of pharmaceutical quality assurance which ensures that products
p.000047: are consistently produced and controlled to quality standards appropriate to their intended use and as required by the
p.000047: marketing authorization.
p.000047:
p.000047: “Herbal Medicinal Product” Includes plant-derived material preparations with therapeutic or any other human
p.000047: health benefits which contain raw or processed ingredients from one or more plants and materials or organic or animal
p.000047: origin.
p.000047:
p.000047: “Institutional Review Board/Independent Ethics Committee (IRB/IEC)” An independent body constituted of medical,
p.000047: scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and
p.000047: well-being of human involved in a trial by, among other things, reviewing, approving, and providing continuing review
p.000047: of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed
p.000047: consent of the trial subjects.
p.000047:
...
p.000047: trial period.
p.000047: 3.2.11.2. The Investigator should have adequate number of qualified staff and adequate facilities for the
p.000047: duration of the trial to conduct the trial properly and safely.
p.000047: 3.2.11.3. The Investigator should ensure that all persons assisting with the trial are adequately informed
p.000047: about the protocol, investigational product and their trial- related duties and functions.
p.000047: 3.2.12. Medical Care of Trial Subjects
p.000047: 3.2.11.1. A qualified medical practitioner should be responsible for all trial-related medical decisions.
p.000047: The qualified medical practitioner should also be licensed with the Medical and Dental Council of Ghana. The
p.000047: medical care given to, and medical decisions made on behalf of the subjects must always be the
p.000047:
p.000047:
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p.000047:
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p.000047:
p.000047: responsibility of a qualified medical practitioner or when appropriate a qualified dentist registered with the
p.000047: Medical and Dental Council.
p.000047: 3.2.11.2. During and following a subject’s participation in a trial, the Investigator should ensure
p.000047: adequate medical care is provided to a subject for any adverse events including clinically significant laboratory
p.000047: values related to the trial. The subject should be informed when medical care is needed for inter-current illness
p.000047: for which the Investigator becomes aware.
p.000047:
p.000047: 3.2.13. Other Investigator Responsibilities
p.000047: 3.2.12.1. Before initiating a trial, the Principal Investigator should have the written and dated approval from
p.000047: the Food and Drugs Authority (FDA) and other relevant bodies.
p.000047: 3.2.12.2. The Investigator should conduct the trial according to the approved protocol.
p.000047: 3.2.12.3. The Investigator shall not implement any deviation from or changes to the protocol and
p.000047: Informed Consent Form without prior review and approval of the FDA except when the changes involve only
p.000047: logistical or administrative aspects of the trial e.g. monitor or telephone number changes or is based on issues
p.000047: relating to the immediate safety of subjects already recruited into the trial.
p.000047: 3.2.12.4. The Investigator shall establish SOPs for investigational products (IP): 3.2.12.4.1. The IP(s)
p.000047: should be kept by a designated person (a
p.000047: pharmacist) who maintain records of the delivery process and who ensures that the product is processed and stored
p.000047: correctly. 3.2.12.4.2. The designated person should maintain an inventory of the IP at the site, those used by
p.000047: each subject and the return to
p.000047: sponsor or alternative disposition of unused product(s).
p.000047: 3.2.12.4.3. The Investigational product(s) should be used only on the subjects participating in the trial.
p.000047: 3.2.12.4.4. The Investigator should ensure that the IP are used only in accordance with the approved
p.000047: protocol.
p.000047:
p.000047:
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p.000047:
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p.000047:
p.000047: 3.2.12.4.5. The Investigator should ensure that if there is blinding, it is maintained but there should be
p.000047: criteria or establishment for breaking of the code.
p.000047: 3.2.12.4.6. The Investigator or a person designated by the Investigator should explain the correct use of
...
p.000047: 4.1.7. Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s)
p.000047: and/or institutions involved in the trial.
p.000047: 4.1.8. Contractual agreement between the investigator and Sponsor.
p.000047: 4.1.9. A clear statement on compensation and benefits package for clinical trial participants.
p.000047: 4.1.10. Publication policy
p.000047:
p.000047:
p.000047: 4.2. Background Information
p.000047: This shall include:
p.000047: 4.2.1. Name and description of the investigational product(s).
p.000047: 4.2.2. A summary of findings from nonclinical studies that potentially have clinical significance to
p.000047: the trial
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 4.2.3. Summary of findings from clinical trials that are relevant to the trial.
p.000047: 4.2.4. Summary of the known and potential risks and benefits, if any, to human subjects.
p.000047: 4.2.5. Description of and justification for the route of administration, dosage, dosage regimen, and
p.000047: treatment period(s).
p.000047: 4.2.6. A statement that the trial shall be conducted in compliance with the protocol, GCP and the applicable
p.000047: regulatory requirement(s).
p.000047: 4.2.7. Description of the population to be studied.
p.000047: 4.2.8. References to literature and data that are relevant to the trial and that provide background
p.000047: for the trial.
p.000047: 4.2.9. Signed declaration by the applicant and all investigators that they are familiar with and
p.000047: understand the protocol and shall comply with principles of Good Clinical Practice (GCP) as determined by
p.000047: the Food and Drugs Authority in the conduct of the trial.
p.000047: 4.2.10. Explanation of the trial being conducted in Ghana and not in the host country of applicant or Sponsor.
p.000047:
p.000047: 4.3. Trial Objectives and Purpose
p.000047: 4.3.1. A detailed description of the objectives and the purpose of the trial.
p.000047: 4.3.2. Aim of the trial and reason for its execution.
p.000047:
p.000047:
p.000047: 4.4. Trial Design
p.000047: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000047: substantially on the trial design. A description of the trial design should include:
p.000047: 4.4.1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the
p.000047: trial.
p.000047: 4.4.2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled, parallel
p.000047: design) and a schematic diagram of trial design, procedures and stages.
p.000047: 4.4.3. A description of the measures taken to minimize/avoid bias, including randomization
p.000047: and blinding.
p.000047:
p.000047:
p.000047:
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p.000047:
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p.000047:
p.000047: 4.4.4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000047: product(s).
p.000047: 4.4.5. Description of the dosage form, packaging, and labeling of the investigational product(s) and sample
p.000047: of label to be used for investigational product.
p.000047: 4.4.6. The expected duration of subject participation, and a description of the sequence and duration of
p.000047: all trial periods, including follow-up, if any.
...
p.000047: 4.11.3. Quality control should be applied to each stage of data handling to ensure that all data are reliable and
p.000047: have been processed correctly. Agreements, made by the sponsor with the principal investigator and any
p.000047: other parties involved with the clinical trial, should be in writing, as part of the protocol or in a
p.000047: separate agreement.
p.000047:
p.000047: 4.12. Ethics
p.000047: 4.12.1. General ethical consideration relating to the trial and informed consent sheet or form or otherwise should be
p.000047: given to patients or volunteers.
p.000047: 4.12.2. In all circumstances provisions made in the current version of ICH E6 R1 with respect to ethics and informed
p.000047: consent should be complied with.
p.000047:
p.000047: 4.13. Data Handling and Record Keeping
p.000047: 4.13.1. Procedure for keeping a list of participating volunteer/subjects and detailed records indicated on
p.000047: the case report form (CRF) for each individual taking part in the trial.
p.000047: 4.13.2. A clear statement on composition and benefit package for clinical trial participants.
p.000047: 4.13.3. All clinical and experimental data (electronic or paper) shall be kept in a secured place for a period of 5
p.000047: years and 20 years for New Drug Application (NDA) after completion of the trial and be made readily available for
p.000047: review upon request by the Authority.
p.000047:
p.000047: 4.14. Financing and Insurance
p.000047: 4.14.1. Financing and insurance if not addressed in a separate agreement
p.000047:
p.000047:
p.000047: 4.15. Publication Policy
p.000047: 4.15.1. Publication policy, if not addressed in a separate agreement
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 23 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: With respect to issues related to protocol amendments refer to section 3.5 of the FDA Guidelines for the conduct of
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047: 5.0. INVESTIGATOR’S BROCHURE
p.000047: 5.1. Investigators Brochure containing information on the following but not limited to:
p.000047: 5.1.1. Chemical, physical and pharmaceutical properties and formulations,
p.000047: 5.1.2. Preclinical, pharmacological and toxicological data,
p.000047: 5.1.3. Human pharmacological and clinical data with the substance concerned and any other supporting
p.000047: documentation sufficient to establish quality, safety and efficacy where applicable.
p.000047: 5.1.4. Marketing experience in countries where the investigational product is being marketed or
p.000047: approved. Where appropriate there should be discussions of published reports.
p.000047: 5.2. Sample of label to be used for the investigational products.
p.000047: 5.3. Clear instructions on storage and handling of investigational products.
p.000047: 5.4. An updated investigator’s brochure should be submitted whenever updated or at least once a year. Additional
p.000047: information and any changes that have been incorporated in the updated investigator’s brochure should be
p.000047: highlighted for ease of review and evaluation
p.000047: 5.5. Good Manufacturing Practice (GMP) certificate/statement from the country of manufacture for
p.000047: the product/ placebo issued by the competent recognized Authority.
p.000047:
p.000047: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000047: The FDA reserves the right to interrupt and inspect any trial for which authorization has been given, as and when
p.000047: necessary for a good cause. An inspection of the conduct of a clinical trial by on-site visits forms part of the
p.000047: Authority’s monitoring activities.
p.000047: 6.1. Periodic Good Clinical Practice (GCP) Inspections of the trial sites shall be conducted to ensure that the
p.000047: facilities used continue to be acceptable throughout the clinical investigation.
p.000047:
p.000047:
p.000047: Page 24 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.2. The inspections may be carried out randomly, and/or for specific reasons and shall be either
p.000047: announced or unannounced.
p.000047: 6.3. An inspection would consist of a comparison of the procedures and practices of the principal
p.000047: investigator with the commitments set out in the protocol and reports submitted to the Authority by the investigator or
p.000047: the sponsor.
p.000047: 6.4. During the inspection the FDA shall assure itself that:
p.000047: 6.4.1. The facilities used by the investigator continue to be acceptable for the purposes of the study.
p.000047: 6.4.2. The approved study protocol for the investigation is being followed.
p.000047: 6.4.3. Any changes to the protocol have been approved by respective Ethics Committees and the Authority.
p.000047: 6.4.4. Accurate, complete and current records are being maintained.
p.000047: 6.4.5. Serious adverse events (SAEs) are reported to the sponsor and to the FDA and institutional review
p.000047: board(s) within the stipulated time as specified in these guidelines.
p.000047: 6.4.6. The investigator is carrying out the agreed-upon activities, and has not delegated them to other previously
p.000047: unspecified staff.
p.000047:
p.000047: To facilitate the above the Authority may require the submission of specific data listing before or during the conduct
p.000047: of a GCP inspection.
p.000047: 6.5. During an inspection, inspectors:
p.000047: 6.5.1. Should be given easy access to the trial sites and laboratories at all times
p.000047: 6.5.2. Should have easy access to all patient files and raw data utilised for and generated during
p.000047: the trial. All site data and documents including participant files must be available for verification.
p.000047: 6.6. All observations and findings shall be verified in order to ensure the credibility of data and to assure that
p.000047: the conclusions that would be presented are derived correctly from the raw data.
p.000047: 6.7. Before an inspection, the principal investigator (or the co-investigator) shall be informed of the impending
p.000047: inspection either in writing, by phone or electronically.
p.000047:
p.000047:
p.000047: Page 25 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.8. An unannounced inspection may however be conducted, if the FDA has reasonable cause to believe that the approved
p.000047: protocol is being violated.
p.000047:
p.000047: Refer to Appendix I for details of an inspection by the FDA.
p.000047:
p.000047:
p.000047:
p.000047: 7.0. CONDUCT OF CLINICAL TRIALS IN VULNERABLE POPULATIONS
p.000047: Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are
p.000047: selected, the means of protecting their rights and welfare must be strictly applied.
p.000047:
...
p.000047: test and access to effective contraceptive methods before the research commences. Where such access is not
p.000047: possible, for legal or religious reasons, investigators should not recruit for such possibly hazardous research
p.000047: women who might become pregnant.
p.000047: 7.3.5. Investigators and ethical review committees should ensure that prospective subjects who are pregnant
p.000047: are adequately informed about the risks and benefits to themselves, their pregnancies, the foetus and
p.000047: their subsequent offspring, and to their fertility.
p.000047: Page 27 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 7.3.6. Research in this population should be performed only if it is relevant to the particular health needs of a
p.000047: pregnant woman or her foetus, or to the health needs of pregnant women in general, and, when appropriate, if
p.000047: it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and
p.000047: mutagenicity.
p.000047:
p.000047: APPENDIX I:
p.000047: DETAILS OF AN INSPECTION BY THE FOOD AND DRUGS AUTHORITY
p.000047:
p.000047: 1.0. SELECTION OF CLINICAL TRIALS FOR INSPECTION
p.000047: Selection of approved clinical trials for GCP inspection shall be based on benefit to risk ratio considering but not
p.000047: limited to the underlisted:
p.000047: 1.1. The phase of the clinical trial
p.000047: 1.2. The nature of the investigational product.
p.000047: 1.3. The market authorization status of the investigational product
p.000047: 1.4. The population under study
p.000047: 1.5. Capacity of trial site
p.000047: 1.6. Previous experience of FDA with sponsor/principal investigator with respect to compliance to GCP
p.000047: requirements.
p.000047:
p.000047: 2.0. WHAT DOES AN INSPECTION INVOLVE?
p.000047: The inspection may involve:
p.000047: 2.1. A comparison of the practices and procedures of the clinical investigator with the commitments made in the
p.000047: application to conduct a clinical trial;
p.000047: 2.2. A comparison of the data submitted to the authority with the source data; and/or
p.000047: 2.3. A system inspection of the sponsor, clinical laboratory or CRO generating data for submission to
p.000047: regulatory authorities. This may include inspection of both the clinical facility and analytical facility.
p.000047:
p.000047: 3.0. THE INSPECTION
p.000047: Details of the various phases of an inspection, including pre-inspection contact; the opening meeting and
p.000047: the actual inspection are outlined below:
p.000047:
p.000047: Page 28 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047: 3.1. Pre-Inspection Contact:
p.000047: Where appropriate, appointments for inspection of an investigational site should be made by a telephone call and/or an
p.000047: e-mail. A written confirmation of the inspection date, time and program (if applicable) may be forwarded to
p.000047: the site, the sponsor company or the CRO.
p.000047: The Local Monitor responsible for the monitoring of the study needs to be present during the inspection.
p.000047: The time span between initial contact and actual inspection shall be as short as possible. Any undue
p.000047: delay of the inspection on the part of the clinical investigator will be investigated.
p.000047:
p.000047: 3.2. Opening Meeting:
p.000047: The purpose of this meeting is for the Inspector(s) to,
p.000047: 3.2.1. explain the purpose of the inspection, i.e. routine or for -cause,
p.000047: 3.2.2. outline the scope of the inspection
p.000047: 3.2.3. and to obtain a brief review of the organization of the site being inspected.
p.000047:
p.000047:
p.000047: 3.3. The Inspection Purpose:
p.000047: The overall purpose of the conduct of the inspection should be to establish whether the investigator has
p.000047: fulfilled his/her GCP responsibilities. This includes the following:
p.000047: 3.3.1. To ascertain whether the investigator is thoroughly familiar with the properties of the investigational
p.000047: product(s) as described in the investigator's brochure.
p.000047: 3.3.2. To ensure that investigator has sufficient time to conduct and complete the clinical study,
p.000047: 3.3.3. To ensure that the investigator has adequate staff and appropriate facilities (including
p.000047: laboratories) available for the duration of the study, and
p.000047: 3.3.4. To ensure that other studies do not divert essential participants or facilities away from the study in hand.
p.000047: 3.3.5. To establish whether the investigator has studied the protocol and whether the assisting personnel
p.000047: have been adequately informed of their responsibilities.
p.000047:
p.000047: Page 29 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.3.6. To determine if the Authority’s and Ethics Committee and other relevant approvals has been
p.000047: obtained with stipulated conditions adhered to.
p.000047: 3.3.7. To determine in what manner the investigational products are handled and stored, and that investigational
p.000047: products are dispensed to study participants in accordance with the protocol and that any unused products are
p.000047: returned to the Sponsor. Reconciliation of trial medication must be provided.
p.000047: 3.3.8. To ensure that the confidentiality of all information about participants is respected (by all persons
p.000047: involved).
p.000047: 3.3.9. To ensure that the investigator observes the following points particularly related to medical care:
p.000047: In addition, the investigator needs to provide retrospective data on numbers of participants who would have satisfied
p.000047: the proposed entrance criteria during preceding time periods in order to assure an adequate recruitment rate
p.000047: for the study. The investigator also needs to provide an up- to-date curriculum vita.
p.000047:
p.000047: The Investigator is medically responsible for those participants who are under his/her care for the duration of the
p.000047: study and must ensure that appropriate medical care is maintained after the study. Where appropriate, fully functional
p.000047: resuscitation equipment should be immediately available in case of emergency. Clinical significant abnormal laboratory
p.000047: values or clinical observations must be followed up after completion of the study.
p.000047:
p.000047: 4.0. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
p.000047: Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial
...
p.000047: corroboration by raw data notations.
p.000047: 6.3. The blinding of medication, if appropriate, must be validated to ensure protection of the study from bias.
p.000047:
p.000047: Page 32 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 6.4. It shall be determined whether distribution of the article was limited to those persons under the
p.000047: investigator's direct supervision.
p.000047: 6.5. The storage area may be inspected.
p.000047: 6.6. It would be determined whether the test article is a controlled substance and whether it is securely
p.000047: locked
p.000047: 6.7. Access to the controlled substance must be restricted to the investigator and the responsible pharmacist.
p.000047:
p.000047: 7.0. LABORATORY
p.000047: The FDA during an inspection would determine the systems and procedures that are followed within an organization that
p.000047: is conducting analysis of samples from clinical trials in compliance with the requirements of Good Clinical Practice
p.000047: (GCP).
p.000047:
p.000047: Inspections of a laboratory being used to analyze samples from a clinical trial shall be in accordance
p.000047: with provisions outlined in the Good Clinical Laboratory Practice Guidelines published by WHO/TDR.
p.000047:
p.000047: 7.1 Transfer of Biological Samples
p.000047: No person shall make arrangements to receive or ship biological samples from a clinical trial without
p.000047: prior approval from the Authority.
p.000047:
p.000047: Persons who wish to import or export any biological samples from a clinical trial shall submit an application and a
p.000047: suitable Material Transfer Agreement for approval by the Authority. The application must be accompanied
p.000047: with the appropriate clearance from a reputable Ethics Committee or Institutional Review Board in Ghana.
p.000047:
p.000047:
p.000047: 8.0 COMPUTER ELECTRONIC DATA SYSTEMS
p.000047: If electronic data systems are involved in gathering data, storing data, or transmitting data to the sponsor, these
p.000047: would be identified and their capabilities established. The following are important:
p.000047: 8.1 The source of data entered into the computer
p.000047:
p.000047: Page 33 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 8.2 The qualification of the personnel to enter data
p.000047: 8.3 At which time/stage should the entering be done
p.000047: 8.4 Provision for access to data and computer
p.000047: 8.5 Security codes
p.000047: 8.6 Procedure and persons responsible for changes and audit trail.
p.000047: 8.7 Procedure for submission of data to sponsor? (hard disk, floppy disk, fax, modern network, mail, messenger)
p.000047: 8.8 Procedures for corrections (errors, omissions, etc.) in the data received and documentation
p.000047: 9.0. EXIT MEETING / INSPECTION REPORT
p.000047: At the post inspection meeting the inspectors would convey the findings of the inspection to the investigator and
p.000047: the representative of the pharmaceutical company or contract research organization and other key
p.000047: members of the study team. The inspection reports shall eventually reflect discussions had at the exit meeting
p.000047:
p.000047: The matters discussed at this meeting shall be in line with the report written by the inspectors. Important matters
p.000047: include:
...
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: If deficiencies were found during the inspection in any of these or in any of the areas it needs to be explained and
p.000047: documentation attached as exhibits.
p.000047:
p.000047: Inspections conducted 'for-cause' would have full reporting. (A for-cause inspection may be the result of prior
p.000047: knowledge or suspicion of alleged violations of Act 851 of the Public Health Act, 2012 and/or guidelines. A for-cause
p.000047: inspection may concentrate the data verification on specific areas of the study or may expand the data verification to
p.000047: cover multiple studies. This inspection may also result when a study is of singular importance to the
p.000047: approval of registration of a medicine, i.e. one of two adequate and well controlled studies.)
p.000047:
p.000047:
p.000047: APPENDIX II
p.000047: ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
p.000047: 1.0. Introduction
p.000047: Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a
p.000047: trial and the quality of the data produced. These documents serve to demonstrate the compliance of the
p.000047: investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory
p.000047: requirements.
p.000047: Essential Documents also serve a number of other important purposes. Filing essential documents
p.000047: at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management
p.000047: of a trial by the investigator, sponsor and monitor. These documents are also the ones which are
p.000047: usually audited by the sponsor's independent audit function and inspected by the regulatory authority(ies)
p.000047: as part of the process to confirm the validity of the trial conduct and the integrity of data collected.
p.000047: The minimum list of essential documents which has been developed follows. The various documents are grouped
p.000047: in three sections according to the stage of the trial during which they will normally be generated: 1) before the
p.000047: clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or
p.000047: termination of the trial. A description is given of the purpose of each document, and whether it should be filed in
p.000047: either the investigator/institution or sponsor files, or both. It is acceptable to combine some of the
p.000047: documents, provided the individual elements are readily identifiable
p.000047:
p.000047: Page 35 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: Trial master files should be established at the beginning of the trial, both at the
p.000047: investigator/institution’s site and at the sponsor's office. A final close-out of a trial can only be done when the
p.000047: monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary
p.000047: documents are in the appropriate files.
p.000047: Any or all of the documents addressed in this guideline may be subject to, and should be available for,
p.000047: audit by the sponsor’s auditor and inspection by the regulatory authority(ies).
p.000047:
p.000047:
p.000047:
p.000047: 2.0. Before the Clinical Phase of the Trial Commences
p.000047: During this planning stage, the following documents should be generated and should be on file before the trial formally
p.000047: starts
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of Investigator Sponsor
p.000047:
p.000047:
p.000047: 1. INVESTIGATOR’S BROCHURE
p.000047:
p.000047:
p.000047: 2. SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)
p.000047:
p.000047: 3. INFORMATION GIVEN TO TRIAL SUBJECT
p.000047: i. - INFORMED CONSENT FORM
p.000047: (including all applicable translations)
p.000047: To document that relevant and current scientific X X information about the
p.000047: investigational product has
p.000047: been provided to the investigator
p.000047:
p.000047:
p.000047: To document investigator and sponsor agreement X X to the protocol/amendment(s) and
p.000047: CRF
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document the informed consent X X
p.000047:
p.000047: Page 36 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: ii.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: iii.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 4.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 5.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 6.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 7.
p.000047: - ANY OTHER WRITTEN INFORMATION
p.000047:
p.000047:
p.000047: - ADVERTISEMENT FOR SUBJECT
p.000047: RECRUITMENT (if used)
p.000047:
p.000047:
p.000047: FINANCIAL ASPECTS OF THE TRIAL
p.000047:
p.000047:
p.000047: INSURANCE STATEMENT
p.000047: (where required)
p.000047:
p.000047:
p.000047: SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:
p.000047: - Investigator/institution and sponsor
p.000047: - Investigator/institution and CRO
p.000047:
p.000047: - Sponsor and CRO
p.000047: - Investigator/institution and authority(ies) (where required)
p.000047:
p.000047: DATED, DOCUMENTED
p.000047: To document that subjects will be given appropriate written information (content and wording) to support their ability
p.000047: to give fully informed consent
p.000047:
p.000047: To document that recruitment measures are appropriate and not coercive
p.000047:
p.000047:
p.000047: To document the financial agreement between the investigator/institution and the sponsor for the trial
p.000047:
p.000047: To document that compensation to subject(s) for trial-related injury will be available
p.000047:
p.000047:
p.000047: To document agreements
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that the trial has been subject to
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: X
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047: Page 37 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: APPROVAL/FAVOURA BLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)
p.000047: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000047: - Protocol and any amendments
p.000047: - CRF (if applicable)
p.000047: - Informed consent form(s)
p.000047: - Any other written information to be provided to the subject(s)
p.000047: - Advertisement for subject recruitment used)
p.000047: - Subject compensation (if any)
p.000047: - Any other documents given approval/ favourable opinion
p.000047: IRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)
p.000047:
p.000047:
p.000047: 8. INSTITUTIONAL REVIEW BOARD/ INDEPENDENT ETHICS COMMITTEE COMPOSITION
p.000047:
p.000047: 9. REGULATORY AUTHORITY(IES)
p.000047: To document that the IRB/IEC is constituted in agreement with GCP
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document appropriate authorization /approval
p.000047: /notification by the regulatory authority(ies) has
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 38 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: AUTHORISATION/ APPROVAL/ NOTIFICATION OF PROTOCOL
p.000047: (where required)
p.000047: been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)
p.000047:
p.000047:
p.000047:
p.000047: 10.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 11.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 12.
p.000047: CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB- INVESTIGATOR(S)
p.000047:
p.000047: NORMAL VALUE(S)
p.000047: /RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL
p.000047:
p.000047: MEDICAL/ LABORATORY/ TECHNICAL PROCEDURES /TESTS -
p.000047: Certification or
p.000047: To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document normal values and/or ranges of the tests
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document competence of facility to perform required test(s), and support reliability of results
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
...
p.000047: /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING:
p.000047: -Protocol amendment(s)
p.000047: -Revision(s) of:
p.000047: - informed consent form
p.000047: - any other written information to be provided to the subject
p.000047: - advertisement for subject recruitment if used)
p.000047: -Any other documents given approval/favourable opinion
p.000047:
p.000047:
p.000047: To document revisions of these trial related X X documents that take
p.000047: effect during trial
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that the amendment(s) and/or X X revision(s) have been
p.000047: subject to IRB/IEC review
p.000047: and were given approval/favourable opinion. To identify the version number and date of the document(s).
p.000047: Page 42 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: -Continuing review of trial (where required)
p.000047:
p.000047:
p.000047: 24.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 25.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 26.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 27.
p.000047: REGULATORY AUTHORITY(IES) AUTHORISATIONS/ APPROVALS/ NOTIFICATIONS WHERE REQUIRED FOR:
p.000047: - Protocol amendment(s) and other documents
p.000047:
p.000047: CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB- INVESTIGATOR(S)
p.000047:
p.000047: UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S
p.000047: ) INCLUDED IN THE PROTOCOL
p.000047:
p.000047: UPDATES OF MEDICAL/LABORATO RY/ TECHNICAL
p.000047: To document compliance with applicable regulatory requirements
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: (see 10)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document normal values and ranges that are revised during the trial (see 11)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document that tests remain adequate throughout the trial period (see 12)
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 43 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: PROCEDURES/TESTS
p.000047: - Certification or
p.000047: - Accreditation or
p.000047: - Established quality control and/or external quality assessment or
p.000047: - Other validation (where required)
p.000047:
p.000047:
p.000047: 28.
p.000047:
p.000047:
...
p.000047:
p.000047: To document all changes/additions or corrections made to CRF after initial data were recorded
p.000047:
p.000047:
p.000047: Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with
p.000047: 3.4 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by Sponsor and/or Investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of
p.000047: unexpected serious adverse drug reactions and of other safety information in
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (copy) (original)
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047: Page 45 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047: 38.
p.000047:
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p.000047:
p.000047: 39.
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047:
p.000047: 40.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 41.
p.000047: TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY
p.000047: INFORMATION NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION
p.000047:
p.000047:
p.000047: INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: SUBJECT SCREENING LOG
p.000047:
p.000047:
p.000047: SUBJECT IDENTIFICATION CODE LIST
p.000047: accordance with 3.3.14 and 3.2.12.8 of FDA Guidelines for GCP in Ghana and 3.4 of FDA Guidelines for Conducting
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Notification by sponsor to investigators of safety information of findings that could affect adversely
p.000047: the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favourable
p.000047: opinion to continue the trial.
p.000047:
p.000047:
p.000047: Interim or annual reports provided to IRB/IEC in accordance with approving IRB/IEC requirements and to authority(ies)
p.000047: in accordance with 3.5.1.2 and 3.5.1.3 of FDA Guidelines for Conducting Clinical Trials in Ghana
p.000047:
p.000047:
p.000047: To document identification of subjects who entered pre-trial screening
p.000047:
p.000047:
p.000047: To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers
p.000047: on enrolling in the trial. Allows
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X X
p.000047: (where required)
p.000047:
p.000047: X
p.000047:
p.000047: Page 46 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 42.
p.000047:
p.000047:
p.000047:
p.000047: 43.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 44.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 45.
p.000047:
p.000047:
p.000047:
p.000047: SUBJECT ENROLMENT LOG
p.000047:
p.000047: INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE
p.000047: SIGNATURE SHEET
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)
p.000047: investigator/institution to reveal identity of any subject
p.000047: X
p.000047: To document chronological enrolment of subjects by trial number
p.000047: X X
p.000047: To document that investigational product(s) have been used according to the protocol
p.000047:
...
p.000047: assays need to be repeated
p.000047:
p.000047:
p.000047:
p.000047: 4.0. After Completion or Termination of the Trial
p.000047: After completion or termination of the trial, all of the documents identified in sections 2.0 and
p.000047: 3.0 of Appendix II should be in the file together with the following
p.000047:
p.000047: Title of Document
p.000047: Purpose
p.000047: Located in Files of Investigator/ Sponsor
p.000047:
p.000047:
p.000047: 46.
p.000047: INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE
p.000047: To document that the investigational product(s) X X have been used according
p.000047: to the protocol. To
p.000047: document the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by
p.000047: the subjects, and returned to sponsor
p.000047:
p.000047: Page 47 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 47.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 48.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 49.
p.000047:
p.000047:
p.000047:
p.000047: 50.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 51.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: 52.
p.000047: DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION
p.000047:
p.000047: COMPLETED SUBJECT IDENTIFICATION CODE LIST
p.000047:
p.000047:
p.000047: AUDIT CERTIFICATE (if
p.000047: available)
p.000047:
p.000047:
p.000047: FINAL TRIAL CLOSE- OUT MONITORING REPORT
p.000047:
p.000047: TREATMENT ALLOCATION AND DECODING DOCUMENTATION
p.000047:
p.000047: FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)
p.000047: To document destruction of unused investigational products by sponsor or at site
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a
p.000047: confidential manner and for agreed upon time
p.000047:
p.000047: To document that audit was performed
p.000047:
p.000047:
p.000047:
p.000047: To document that all activities required for trial close-out are completed, and copies of essential documents are held
p.000047: in the appropriate files
p.000047:
p.000047: Returned to sponsor to document any decoding that may have occurred
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: To document completion of the trial
p.000047: X X
p.000047: (if destroyed at site)
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: X
p.000047:
p.000047:
p.000047: Page 48 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047:
p.000047: 53. CLINICAL STUDY REPORT
p.000047: To document results and interpretation of trial X X (if
p.000047: applicable)
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
...
General/Other / cioms guidelines
Searching for indicator cioms:
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p.000033: 9.0. EXIT MEETING / INSPECTION REPORT
p.000034: 34
p.000034: APPENDIX II
p.000035: 35
p.000035: ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL 35
p.000035: 1.0. Introduction
p.000035: 35
p.000035: 2.0. Before the Clinical Phase of the Trial Commences
p.000036: 36
p.000036: 3.0. During the Clinical Conduct of the Trial
p.000041: 41
p.000041: 4.0. After Completion or Termination of the Trial
p.000047: 47
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 1.0. INTRODUCTION
p.000047: The purpose of these guidelines is to provide investigators conducting clinical trials in Ghana with clear
p.000047: standards of good clinical practice. The Guidelines seeks to ensure that clinical trials conducted in Ghana are
p.000047: designed and conducted according to sound scientific and ethical standards within the framework of good
p.000047: clinical practice. Compliance with these standards provides the public with assurance that the rights, safety and
p.000047: wellbeing of trial participants are protected and that clinical trial data are credible.
p.000047:
p.000047: The guidelines were partly derived from the International Conference on Harmonization Good Clinical Practice (ICH
p.000047: GCP) and from the International Ethical Guidelines for Biomedical Research involving human subjects prepared by
p.000047: the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with World Health Organization
p.000047: (WHO 2002).
p.000047:
p.000047: Good Clinical Practice (GCP) is a system of shared responsibilities between clinical
p.000047: investigators, industry/sponsors/monitors, institutions/ethics committees, and government regulators. The
p.000047: Guidelines are therefore addressed to investigators, pharmaceutical, manufacturers and other
p.000047: sponsors of research, drug regulatory authorities, the general public and all, those who have an interest in clinical
p.000047: trials research in Ghana.
p.000047:
p.000047: These Guidelines will support the regulatory requirements of the Food and Drugs Authority as stipulated in part 8, Act
p.000047: 851 of the Public Health Act 2012. It is therefore critical that research ethics committees, researchers, trial
p.000047: participants, principal investigators of trials and sponsors use these guidelines so as to ensure a standardized and
p.000047: ethical approach to clinical trial conducted in Ghana.
p.000047:
p.000047: The guidelines are also applicable to academic and contract clinical research and are intended to be applied during all
p.000047: stages of drug development including pre and post product registration and marketing, and they are also applicable, in
p.000047: whole or in part to biomedical research in general. They also provide a resource for editors to determine the
p.000047: acceptability of reported research for publication and specifically, on any study that could influence the use or the
...
p.000047: 3.3.14. The Sponsor should report to the FDA and all relevant institutions, all adverse events occurring during
p.000047: the course of the trial. The Sponsor should expedite reporting all serious adverse events to the Ethics
p.000047: Committee, the FDA and the Sponsor and the Investigators should immediately undertake appropriate and necessary
p.000047: measures and treatment to protect the trial subjects. (Refer to Guidelines for the Conduct of Clinical Trials for
p.000047: timelines).
p.000047: 3.3.15. When a trial is prematurely terminated or suspended by the Sponsor/Investigators, the FDA and Ethics
p.000047: Committee and should be informed of the decision to terminate/suspend the trial and the reasons
p.000047: thereof by the Sponsor/Investigators. (Refer to Guidelines for the Conduct of Clinical Trials for further details).
p.000047: 3.3.16. When the trial is prematurely terminated, the Sponsor should submit a report to the FDA and institution
p.000047: within 30 (thirty) days.
p.000047: Page 16 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.3.17. When the trial is completed, the Sponsor should submit a preliminary report to the FDA and institution
p.000047: within 30 (thirty) days.
p.000047: 3.3.18. The external Sponsor should strengthen local capacity for ethical, scientific review, biomedical research
p.000047: and provide healthcare services as described in sections 20, 21 of the International Ethical Guidelines for
p.000047: Biomedical Research involving Human Subjects (CIOMS 2002).
p.000047:
p.000047: Sponsors and Investigators have an ethical obligation to ensure that biomedical research projects
p.000047: contribute effectively to national or local capacity building. Capacity building may include, but is not
p.000047: limited to, the following activities:
p.000047: 3.3.18.1.1 Establishing and strengthening independent and competent ethical review processes/committees.
p.000047: 3.3.18.1.2 Developing technologies appropriate to health-care and biomedical research.
p.000047: 3.3.18.1.3 Training of research and health-care staff.
p.000047: 3.3.18.1.4 Educating the community from which research subjects will be drawn.
p.000047: 3.3.19. External Sponsors are ethically obliged to ensure the availability of:
p.000047: 3.3.19.1. health-care services that are essential to the safe conduct of the research
p.000047: 3.3.19.2. treatment of subjects who suffer injury as a consequence of research intervention; and
p.000047: 3.3.19.3. services that are a necessary part of the commitment of a sponsor to make a beneficial intervention or
p.000047: product developed as a result of the research reasonably available to the population or community concerned.
p.000047:
p.000047: 3.3.20 The Sponsor shall appoint a Local Monitor to oversee the progress of a clinical trial and to ensure that it is
p.000047: conducted, recorded and reported in accordance with the SOPs, GCP and the applicable regulatory requirements.
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
p.000047: Page 17 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 4.0. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
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p.000047: 3.2.4. To permit monitoring and auditing of the trial and inspection by the FDA or appointed representatives.
p.000047: 3.2.5. Keep a list of appropriately qualified persons to whom the Investigator has delegated significant
p.000047: trial-related duties.
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 3.2.6. The Principal Investigator shall ensure that all members of the study team have evidence of GCP training of
p.000047: not more than 2 years. GCP certificates shall be required for key members of the team.
p.000047: 3.2.7. The Investigator should not have been found guilty of any misconduct under the Ghana Medical and Dental
p.000047: Decree.
p.000047: 3.2.8. The Principal Investigator must be an appropriately qualified and competent person having practical
p.000047: experience within the relevant professional area, who is resident in the country and who is responsible for the
p.000047: conduct of the clinical trial at a clinical site. A Principal Investigator must have had previous experience as a
p.000047: co-investigator in at least two trials in the relevant professional area.
p.000047: 3.2.9. All investigators in a clinical trial as well as the trial monitor must have had formal
p.000047: training in Good Clinical Practice (GCP) within the last two years.
p.000047: 3.2.10. Upon signing the application, all parties accept the responsibility that all applicable regulations
p.000047: and requirements will be adhered to. Furthermore, all parties are responsible for ensuring that the trial is
p.000047: based on and implemented according to well – founded ethical and scientific principles, which are expressed in
p.000047: the Helsinki Declaration and its current revisions as well as in the local and international guidelines for GCP.
p.000047: 3.2.11. Adequate Resources
p.000047: 3.2.11.1. The Investigator should have sufficient time to properly conduct and complete the trial within the agreed
p.000047: trial period.
p.000047: 3.2.11.2. The Investigator should have adequate number of qualified staff and adequate facilities for the
p.000047: duration of the trial to conduct the trial properly and safely.
p.000047: 3.2.11.3. The Investigator should ensure that all persons assisting with the trial are adequately informed
p.000047: about the protocol, investigational product and their trial- related duties and functions.
p.000047: 3.2.12. Medical Care of Trial Subjects
p.000047: 3.2.11.1. A qualified medical practitioner should be responsible for all trial-related medical decisions.
p.000047: The qualified medical practitioner should also be licensed with the Medical and Dental Council of Ghana. The
p.000047: medical care given to, and medical decisions made on behalf of the subjects must always be the
p.000047:
p.000047:
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p.000047:
p.000047: responsibility of a qualified medical practitioner or when appropriate a qualified dentist registered with the
p.000047: Medical and Dental Council.
p.000047: 3.2.11.2. During and following a subject’s participation in a trial, the Investigator should ensure
p.000047: adequate medical care is provided to a subject for any adverse events including clinically significant laboratory
p.000047: values related to the trial. The subject should be informed when medical care is needed for inter-current illness
p.000047: for which the Investigator becomes aware.
p.000047:
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General/Other / participants in a control group
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p.000047: data), and to be considered to be source data
p.000047: 4.4.12. Number of human subjects to be involved in the trial and the statistical justification.
p.000047: 4.4.13. Specifications and instructions for anticipated deviations from the protocol.
p.000047:
p.000047:
p.000047: 4.5. Selection and Withdrawal of Subjects
p.000047: 4.5.1. Subject inclusion criteria.
p.000047: 4.5.2. Subject exclusion criteria.
p.000047: 4.5.3. Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and
p.000047: procedures specifying:
p.000047: 4.5.3.1. When and how to withdraw subjects from the trial/investigational product treatment.
p.000047: 4.5.3.2. The type and timing of the data to be collected for withdrawn subjects.
p.000047: 4.5.3.3. Whether and how subjects are to be replaced.
p.000047: 4.5.3.4. The follow-up for subjects withdrawn from investigational product treatment/trial
p.000047: treatment.
p.000047:
p.000047:
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p.000047:
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p.000047:
p.000047: 4.6. Treatment of Subjects
p.000047: 4.6.1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing
p.000047: schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s)
p.000047: for subjects for each investigational product treatment/trial treatment group/arm of the trial.
p.000047: 4.6.2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before
p.000047: and/or during the trial.
p.000047: 4.6.3. Procedures for monitoring subject compliance.
p.000047: 4.6.4. Description of treatment applied to control group(s) or control period(s), placebo, and other therapy
p.000047: and any other treatment that may be given concomitantly including measures to be implemented to ensure the safe
p.000047: handling of the products
p.000047: 4.6.5. Description of diagnostic devices or kits applied to be used in the clinical trial.
p.000047: 4.6.6. Description of special analyses and/or tests or procedure to be carried out.
p.000047:
p.000047:
p.000047: 4.7. Assessment of Efficacy
p.000047: 4.7.1. Specification of the efficacy parameters.
p.000047: 4.7.2. Methods and timing for assessing, recording, and analyzing of efficacy parameters.
p.000047: 4.7.3. Clear procedures for interim assessment of trial
p.000047:
p.000047:
p.000047: 4.8. Assessment of Safety
p.000047: 4.8.1. Specification of safety parameters.
p.000047: 4.8.2. The methods and timing for assessing, recording, and analyzing safety parameters.
p.000047: 4.8.3. Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.
p.000047: 4.8.4. The type and duration of the follow-up of subjects after adverse events.
p.000047: 4.8.5. Provision for dealing with all adverse events. Copy of form to be used to report adverse event.
p.000047: 4.8.6. Criteria for the termination of the trial
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: 4.9. Statistics
p.000047: 4.9.1. A description of the statistical methods to be employed, including timing of any planned interim
p.000047: analysis(ses).
p.000047: 4.9.2. The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects
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p.000047: documents, facilities, records and any other resources that are deemed to be related to the clinical trial and that may
p.000047: be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO’s) facilities, or at
p.000047: other establishments deemed appropriate by the FDA.
p.000047:
p.000047:
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p.000047:
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p.000047:
p.000047: “Good Manufacturing Practice (GMP)” The part of pharmaceutical quality assurance which ensures that products
p.000047: are consistently produced and controlled to quality standards appropriate to their intended use and as required by the
p.000047: marketing authorization.
p.000047:
p.000047: “Herbal Medicinal Product” Includes plant-derived material preparations with therapeutic or any other human
p.000047: health benefits which contain raw or processed ingredients from one or more plants and materials or organic or animal
p.000047: origin.
p.000047:
p.000047: “Institutional Review Board/Independent Ethics Committee (IRB/IEC)” An independent body constituted of medical,
p.000047: scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and
p.000047: well-being of human involved in a trial by, among other things, reviewing, approving, and providing continuing review
p.000047: of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed
p.000047: consent of the trial subjects.
p.000047:
p.000047: “Investigational Product” A pharmaceutical form of an active ingredient or placebo being tested or used as a reference
p.000047: in a clinical trial including a product with a marketing authorization when used or assembled in a way different from
p.000047: the approved form, or when used for an unapproved indication or when used to gain further information about an approved
p.000047: use.
p.000047:
p.000047: “Investigator’s Brochure” A collection of data consisting of all the information known prior to the clinical trial
p.000047: concerning the clinical and non clinical data on the investigational product(s). There should be adequate data to
p.000047: justify the nature, scale and duration of the proposed trial.
p.000047:
p.000047: “Local Monitor” A person appointed by the Sponsor or CRO to oversee the progress of a clinical trial and
p.000047: of ensuring that it is conducted, recorded and reported in accordance with the SOPs, GCP and the applicable regulatory
p.000047: requirements.
p.000047:
p.000047: “Lot Release Certificate (LRC)” An official document that authorizes the manufacturer to release a specific
p.000047: lot of a product.
p.000047:
p.000047:
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p.000047:
p.000047: “Medical Device” As defined in Part Seven, Section 149 of the Public Health Act 2012, Act 851.
p.000047:
p.000047:
p.000047: “Placebo” A medication with no active ingredients or a procedure without any medical benefit.
p.000047:
p.000047:
p.000047: “Principal Investigator / Investigator” The person responsible for the conduct of the clinical trial at the clinical
p.000047: trial site, who is entitled to provide health care under the laws of the Country where that clinical trial site is
p.000047: located.
p.000047:
p.000047: “Protocol Amendment” A written description of a change(s) to or formal clarification of a protocol.
p.000047:
p.000047: “Protocol” A document that describes the objective(s), design, methodology, statistical
p.000047: considerations and the organization of a trial. The protocol usually also gives the background and rationale for the
p.000047: trial, but these could be provided in other protocol referenced documents.
p.000047:
p.000047: “Research Institution” Any public or private entity, agency, medical or dental facility where clinical trials
p.000047: are conducted.
p.000047:
p.000047: “Serious Adverse Event (SAE)” means any untoward medical occurrence that at any dose results in death, is
p.000047: life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in
p.000047: persistent or significant disability/incapacity or is a congenital anomaly/birth defect (ICH definition
p.000047: 1997).
p.000047:
p.000047: “Sponsor” An individual, company, institution or organization which takes responsibility for the initiation,
p.000047: management and/or financing of a trial. This excludes an individual company, institution or organization
p.000047: which has been requested to provide money for a trial and does not benefit in any way from the results of the trial.
p.000047:
...
p.000047: writing as part of the protocol submitted for FDA’s approval or in a separate agreement. The Sponsor, in a
p.000047: written document, may agree to transfer all related activities of the clinical trial to designated research
p.000047: institutions. However, all responsibility for the trial lies with the Sponsor.
p.000047: 3.3.4. The Sponsor shall provide an up-to-date Investigator’s brochure, which includes information about
p.000047: the products with respect to their physical, chemical, pharmacokinetic and pharmacodynamic properties
p.000047: obtained from animals as well as human subjects and currently available results of relevant clinical trials.
p.000047: An updated Investigator’s Brochure shall be submitted whenever available; at least once year.
p.000047: 3.3.5. The Sponsor shall obtain the investigator’s/institutions’ agreement on the following
p.000047: items:
p.000047: 3.3.5.1. The conduct of the trial in compliance with Good Clinical Practices and with the approved protocol; and
p.000047: to be in compliance with procedures for data recording/reporting and to permit monitoring, auditing
p.000047: and inspection according to the protocol.
p.000047: 3.3.5.2. The Sponsor and all investigators shall sign and date the protocol of the trial to confirm the agreement.
p.000047: 3.3.6. The Sponsor shall ensure that sufficient safety and efficacy data from non-clinical studies and/or
p.000047: clinical trials are available to support human exposure by the route, at the dosages for the duration and in the trial
p.000047: population to be studied.
p.000047: 3.3.7. The Sponsor shall ensure that the IP’s (including active comparator(s) and placebo) is manufactured in
p.000047: accordance with Good Manufacturing Practices and are adequately packed and labelled in a manner that protects the
p.000047: blinding if applicable. In addition
p.000047:
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p.000047: the labelling should comply with the regulatory requirements (refer to FDA’s Guidelines for Labeling of
p.000047: Products).
p.000047: 3.3.8. The Sponsor shall determine for the IP’s, acceptable storage temperature and conditions, storage
p.000047: times, reconstitution fluids and procedures and devices for product infusion if any.
p.000047: 3.3.9. In blinded trials, the coding system for the IP’s shall include a mechanism that permits rapid
p.000047: identification of the products in case of a medical emergency but does not permit undetectable breaks of the blinding.
p.000047: 3.3.10. If formulation changes are made to the IP or comparator products during the course of the clinical
p.000047: development, the results of pharmaceutical and pharmacokinetic profile of the product shall be made available to the
p.000047: FDA prior to the use of the reformulated IP in clinical trials.
p.000047: 3.3.11. The Sponsor shall appoint qualified and suitable trained individuals to monitor the trial.
p.000047: 3.3.12. The Sponsor should provide insurance cover for all trial subjects. The Sponsor’s policies and
p.000047: procedures should address the costs of treatment of trial subjects in the event of trial-related injuries.
p.000047: 3.3.13. The financial aspects of the trial should be documented in an agreement between the Sponsor and the
p.000047: Investigator/institution.
...
p.000047: 4.2.5. Description of and justification for the route of administration, dosage, dosage regimen, and
p.000047: treatment period(s).
p.000047: 4.2.6. A statement that the trial shall be conducted in compliance with the protocol, GCP and the applicable
p.000047: regulatory requirement(s).
p.000047: 4.2.7. Description of the population to be studied.
p.000047: 4.2.8. References to literature and data that are relevant to the trial and that provide background
p.000047: for the trial.
p.000047: 4.2.9. Signed declaration by the applicant and all investigators that they are familiar with and
p.000047: understand the protocol and shall comply with principles of Good Clinical Practice (GCP) as determined by
p.000047: the Food and Drugs Authority in the conduct of the trial.
p.000047: 4.2.10. Explanation of the trial being conducted in Ghana and not in the host country of applicant or Sponsor.
p.000047:
p.000047: 4.3. Trial Objectives and Purpose
p.000047: 4.3.1. A detailed description of the objectives and the purpose of the trial.
p.000047: 4.3.2. Aim of the trial and reason for its execution.
p.000047:
p.000047:
p.000047: 4.4. Trial Design
p.000047: The scientific integrity of the trial and the credibility of the data from the trial depend
p.000047: substantially on the trial design. A description of the trial design should include:
p.000047: 4.4.1. A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the
p.000047: trial.
p.000047: 4.4.2. A description of the type/design of trial to be conducted (e.g. double-blind, placebo- controlled, parallel
p.000047: design) and a schematic diagram of trial design, procedures and stages.
p.000047: 4.4.3. A description of the measures taken to minimize/avoid bias, including randomization
p.000047: and blinding.
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: 4.4.4. A description of the trial treatment(s) and the dosage and dosage regimen of the investigational
p.000047: product(s).
p.000047: 4.4.5. Description of the dosage form, packaging, and labeling of the investigational product(s) and sample
p.000047: of label to be used for investigational product.
p.000047: 4.4.6. The expected duration of subject participation, and a description of the sequence and duration of
p.000047: all trial periods, including follow-up, if any.
p.000047: 4.4.7. Quantities of investigational medicines and placebos to be used during the conduct of the study.
p.000047: 4.4.8. A detailed description of the "stopping rules" or "discontinuation criteria" for individual
p.000047: subjects, parts of trial and entire trial.
p.000047: 4.4.9. Accountability procedures for the investigational product(s), including the placebo(s) and
p.000047: comparator(s), if any.
p.000047: 4.4.10. Maintenance of trial treatment randomization codes and procedures for breaking codes.
p.000047: 4.4.11. The identification of any data to be recorded directly on the CRFs (i.e. written or electronic record of
p.000047: data), and to be considered to be source data
p.000047: 4.4.12. Number of human subjects to be involved in the trial and the statistical justification.
p.000047: 4.4.13. Specifications and instructions for anticipated deviations from the protocol.
p.000047:
p.000047:
p.000047: 4.5. Selection and Withdrawal of Subjects
p.000047: 4.5.1. Subject inclusion criteria.
p.000047: 4.5.2. Subject exclusion criteria.
p.000047: 4.5.3. Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and
p.000047: procedures specifying:
p.000047: 4.5.3.1. When and how to withdraw subjects from the trial/investigational product treatment.
p.000047: 4.5.3.2. The type and timing of the data to be collected for withdrawn subjects.
p.000047: 4.5.3.3. Whether and how subjects are to be replaced.
p.000047: 4.5.3.4. The follow-up for subjects withdrawn from investigational product treatment/trial
p.000047: treatment.
p.000047:
p.000047:
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p.000047:
p.000047: 4.6. Treatment of Subjects
p.000047: 4.6.1. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing
p.000047: schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s)
p.000047: for subjects for each investigational product treatment/trial treatment group/arm of the trial.
p.000047: 4.6.2. Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before
p.000047: and/or during the trial.
p.000047: 4.6.3. Procedures for monitoring subject compliance.
p.000047: 4.6.4. Description of treatment applied to control group(s) or control period(s), placebo, and other therapy
p.000047: and any other treatment that may be given concomitantly including measures to be implemented to ensure the safe
p.000047: handling of the products
p.000047: 4.6.5. Description of diagnostic devices or kits applied to be used in the clinical trial.
p.000047: 4.6.6. Description of special analyses and/or tests or procedure to be carried out.
p.000047:
p.000047:
p.000047: 4.7. Assessment of Efficacy
p.000047: 4.7.1. Specification of the efficacy parameters.
p.000047: 4.7.2. Methods and timing for assessing, recording, and analyzing of efficacy parameters.
p.000047: 4.7.3. Clear procedures for interim assessment of trial
p.000047:
p.000047:
p.000047: 4.8. Assessment of Safety
p.000047: 4.8.1. Specification of safety parameters.
p.000047: 4.8.2. The methods and timing for assessing, recording, and analyzing safety parameters.
p.000047: 4.8.3. Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.
p.000047: 4.8.4. The type and duration of the follow-up of subjects after adverse events.
p.000047: 4.8.5. Provision for dealing with all adverse events. Copy of form to be used to report adverse event.
p.000047: 4.8.6. Criteria for the termination of the trial
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: 4.9. Statistics
p.000047: 4.9.1. A description of the statistical methods to be employed, including timing of any planned interim
p.000047: analysis(ses).
p.000047: 4.9.2. The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects
p.000047: projected for each trial site should be specified.
p.000047: 4.9.3. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and
...
p.000047: 4.15.1. Publication policy, if not addressed in a separate agreement
p.000047:
p.000047:
p.000047:
p.000047:
p.000047:
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p.000047:
p.000047: With respect to issues related to protocol amendments refer to section 3.5 of the FDA Guidelines for the conduct of
p.000047: Clinical Trials in Ghana.
p.000047:
p.000047:
p.000047:
p.000047: 5.0. INVESTIGATOR’S BROCHURE
p.000047: 5.1. Investigators Brochure containing information on the following but not limited to:
p.000047: 5.1.1. Chemical, physical and pharmaceutical properties and formulations,
p.000047: 5.1.2. Preclinical, pharmacological and toxicological data,
p.000047: 5.1.3. Human pharmacological and clinical data with the substance concerned and any other supporting
p.000047: documentation sufficient to establish quality, safety and efficacy where applicable.
p.000047: 5.1.4. Marketing experience in countries where the investigational product is being marketed or
p.000047: approved. Where appropriate there should be discussions of published reports.
p.000047: 5.2. Sample of label to be used for the investigational products.
p.000047: 5.3. Clear instructions on storage and handling of investigational products.
p.000047: 5.4. An updated investigator’s brochure should be submitted whenever updated or at least once a year. Additional
p.000047: information and any changes that have been incorporated in the updated investigator’s brochure should be
p.000047: highlighted for ease of review and evaluation
p.000047: 5.5. Good Manufacturing Practice (GMP) certificate/statement from the country of manufacture for
p.000047: the product/ placebo issued by the competent recognized Authority.
p.000047:
p.000047: 6.0. GOOD CLINICAL PRACTICE INSPECTIONS
p.000047: The FDA reserves the right to interrupt and inspect any trial for which authorization has been given, as and when
p.000047: necessary for a good cause. An inspection of the conduct of a clinical trial by on-site visits forms part of the
p.000047: Authority’s monitoring activities.
p.000047: 6.1. Periodic Good Clinical Practice (GCP) Inspections of the trial sites shall be conducted to ensure that the
p.000047: facilities used continue to be acceptable throughout the clinical investigation.
p.000047:
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p.000047: 6.2. The inspections may be carried out randomly, and/or for specific reasons and shall be either
p.000047: announced or unannounced.
p.000047: 6.3. An inspection would consist of a comparison of the procedures and practices of the principal
p.000047: investigator with the commitments set out in the protocol and reports submitted to the Authority by the investigator or
p.000047: the sponsor.
p.000047: 6.4. During the inspection the FDA shall assure itself that:
p.000047: 6.4.1. The facilities used by the investigator continue to be acceptable for the purposes of the study.
p.000047: 6.4.2. The approved study protocol for the investigation is being followed.
p.000047: 6.4.3. Any changes to the protocol have been approved by respective Ethics Committees and the Authority.
p.000047: 6.4.4. Accurate, complete and current records are being maintained.
...
Orphaned Trigger Words
p.000047: logistical or administrative aspects of the trial e.g. monitor or telephone number changes or is based on issues
p.000047: relating to the immediate safety of subjects already recruited into the trial.
p.000047: 3.2.12.4. The Investigator shall establish SOPs for investigational products (IP): 3.2.12.4.1. The IP(s)
p.000047: should be kept by a designated person (a
p.000047: pharmacist) who maintain records of the delivery process and who ensures that the product is processed and stored
p.000047: correctly. 3.2.12.4.2. The designated person should maintain an inventory of the IP at the site, those used by
p.000047: each subject and the return to
p.000047: sponsor or alternative disposition of unused product(s).
p.000047: 3.2.12.4.3. The Investigational product(s) should be used only on the subjects participating in the trial.
p.000047: 3.2.12.4.4. The Investigator should ensure that the IP are used only in accordance with the approved
p.000047: protocol.
p.000047:
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p.000047: 3.2.12.4.5. The Investigator should ensure that if there is blinding, it is maintained but there should be
p.000047: criteria or establishment for breaking of the code.
p.000047: 3.2.12.4.6. The Investigator or a person designated by the Investigator should explain the correct use of
p.000047: the IP to each subject and should check at appropriate intervals during the trial that each subject is following
p.000047: the instructions. In the case where the IP is administered to the subject the proper administration should be ensured.
p.000047: 3.2.12.5. The Investigator shall ensure that the subjects have signed and dated the consent form or
p.000047: given their consent in an acceptable form before participating in the trial.
p.000047: 3.2.12.6. The Investigator shall guarantee the confidentiality of the research data, the trial subjects’
p.000047: details and information provided by Sponsor.
p.000047: 3.2.12.7. The Investigator shall ensure that all data is accurately collected and recorded.
p.000047: 3.2.12.8. The Investigator shall ensure that all serious adverse events are reported promptly to the
p.000047: FDA within timelines specified in the FDA’s Guideline for the Conduct of Clinical Trials. Proper
p.000047: protection procedures or treatments should be administered to trial subjects with serious adverse events.
p.000047: 3.2.12.9. The Investigator shall submit all relevant trial data to the FDA in a timely manner for
p.000047: validation, auditing and inspection.
p.000047:
p.000047: 3.3. SPONSOR
p.000047: 3.3.1. The Sponsor is responsible for implementing and maintaining quality assurance and quality control
p.000047: systems with written SOPs to ensure that trials are conducted and data are generated, recorded and reported in
p.000047: compliance with the protocol, GCP and regulatory requirements.
p.000047: 3.3.2. The Sponsor is responsible for selecting Investigators according to the availability of adequate
p.000047: clinical trial environment facilities and resources. In addition, the Sponsor shall ensure that the
p.000047: investigator has sufficient training, qualifications and capability.
p.000047:
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p.000047:
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p.000047:
p.000047: 3.3.3. The Sponsor shall agree with investigator(s) on the definition, establishment and assignment of
p.000047: responsibilities specified in the protocol. These responsibilities include data management, unblinding
p.000047: of treatment codes, statistical considerations and preparation of the final clinical report.
p.000047:
p.000047: Prior to the initiation of the clinical trial, the agreement between the Sponsor and Investigators should be in
p.000047: writing as part of the protocol submitted for FDA’s approval or in a separate agreement. The Sponsor, in a
p.000047: written document, may agree to transfer all related activities of the clinical trial to designated research
p.000047: institutions. However, all responsibility for the trial lies with the Sponsor.
...
p.000047:
p.000047: 4.1. Before the clinical phase of the trial commences,
p.000047: 4.2. During the clinical conduct of the trial, and
p.000047: 4.3. After completion or termination of the trial.
p.000047: A description is given of the purpose of each document, and whether it should be filed in either the
p.000047: investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents,
p.000047: provided the individual elements are readily identifiable.
p.000047: Trial master files should be established at the beginning of the trial, both at the
p.000047: investigator/institution's site and at the sponsor's office. A final close-out of a trial can only be done when the
p.000047: study monitor(s) has reviewed both investigator/institution and sponsor files and confirmed that all necessary
p.000047: documents are in the appropriate files.
p.000047: Any or all of the documents addressed in this guideline may be subject to, and should be available for,
p.000047: audit by the sponsor's auditor and inspection by the FDA.
p.000047:
p.000047: 5.0. TRIAL PROCEDURES
p.000047: This part identifies the nature of the information that shall be obtained during each inspection to determine if the
p.000047: clinical investigator is meeting his/her obligation as trialist. This outline provides only the minimal scope
p.000047: of the inspection and the inspector shall extend the inspection as the facts evolve. The inspection conducted
p.000047: shall be sufficient in scope to determine compliance with Good Clinical Practice.
p.000047: Scientific data shall not be evaluated during the inspection, but only verify documentation and validate data. An
p.000047: inspection may include the following checks:
p.000047: 5.1. The protocol, included amendments must be signed by the investigator.
p.000047: 5.2. Ethics Committee and regulatory approval documentation.
p.000047: 5.3. Validation of signed informed consent documents. Signatures shall be checked against evidence on
p.000047: patient files. It would be determined whether written informed consent was obtained for all participants
p.000047: prior to the entry into the study and whether this was recorded in the participants medical records. A copy of the
p.000047: information presented orally may also be obtained.
p.000047: 5.4. Participant records shall be verified.
p.000047: 5.5. The condition, organization, completeness and legibility of the investigator's raw data files may need to be
p.000047: described.
p.000047:
p.000047: Page 31 of 48
p.000047:
p.000047: FDA/SMC/CTD/GL-GCP/2013/02
p.000047:
p.000047: 5.6. Necessary processes would be put in place to determine whether there is adequate documentation to
p.000047: assure that all inspected participants did exist and were available for the duration of their stated
p.000047: participation in the study.
p.000047: 5.7. The raw data in the clinical investigator's records would be compared with the completed case record forms.
p.000047: The following shall also be determined:
p.000047: 5.8. Whether the number and type of participants entered into the study were confined to the protocol limitations
p.000047: 5.9. Whether the inclusion and exclusion criteria as specified in the protocol were followed
p.000047: 5.10. Observations, information, and data condition of the participants at the time of entering into the trial.
p.000047: 5.11. Observations and data on the condition of the participant throughout participation in the investigation,
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| blind | visual impairment |
| blinded | visual impairment |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| control group | participants in a control group |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| foetus | Fetus/Neonate |
| helsinki | declaration of helsinki |
| illness | Physically Disabled |
| impaired | Cognitive Impairment |
| incapacity | Incapacitated |
| influence | Drug Usage |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| parent | parents |
| party | political affiliation |
| placebo | participants in a control group |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| religious | Religion |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| blind | ['blinded'] |
| blinded | ['blind'] |
| child | ['children'] |
| children | ['child'] |
| control group | ['placebo'] |
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| placebo | ['controlXgroup'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
consent
developing
ethics
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input