0A4F4F9BD490A749D5437F821CF06DF1
Guides for the Conduct of Clinical Trials
http://med.pdn.ac.lk/notices/staffnotices/2015/April/Guidelines%20for%20the%20conduct%20of%20clinical%20trials%20in%20Sri%20Lanka.pdf
http://leaux.net/URLS/ConvertAPI Text Files/126012FA9AE6E8AA64FEA4F330E63ED8.en.txt
Examining the file media/Synopses/126012FA9AE6E8AA64FEA4F330E63ED8.html:
This file was generated: 2020-07-14 10:33:37
| 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
Health / Drug Dependence
Searching for indicator dependence:
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p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 11 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
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p.000012: Glossary
p.000012:
p.000012:
p.000012: “Adverse Event (AE)” means any untoward medical occurrence in a patient or clinical investigation subject
p.000012: administered a medicinal product and which does not necessarily have a causal relationship with this
p.000012: treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
p.000012: laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product,
p.000012: whether or not considered related to the medicinal (investigational) product;
p.000012: “Adverse Drug Reaction (ADR)” means a response to a pharmaceutical product that is noxious and unintended
p.000012: and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or
p.000012: for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse
p.000012: or dependence and interactions with any other product should be considered adverse reactions.
p.000012: “CIOMS-I format” means a format for reporting adverse drug reactions according to the Council of International
p.000012: Organizations for Medical Sciences.
p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
p.000012: or more health-related interventions to evaluate the effects on health outcomes. Interventions may include
p.000012: but are not restricted to substances such as drugs, cells and other biological products, vaccines,
p.000012: surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms
p.000012: “clinical trial” and “clinical study” are synonymous;
p.000012: “Contract research organization (CRO)” means a scientific organization (commercial, academic or other) to
p.000012: which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
...
Health / Drug Usage
Searching for indicator drug:
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p.000012: 38. If a participant in a clinical trial refuses to give consent referred to in section 30, the principal investigator
p.000012: should immediately cease to use that person as a participant in the clinical trial.
p.000012:
p.000012: Participants to be treated by designated investigators
p.000012: 39. During the conduct of a clinical trial, no person, other than a holder of an approval, or a
p.000012: designated principal investigator approved by SCOCT, or any person assisting him in a clinical trial
p.000012: should treat a study participant or administer any test material to such study participant.
p.000012: 40. In an emergency, any doctor or dentist may, in the absence of the holder of an approval, or a designated
p.000012: principal investigator approved by SCOCT or any person assisting him in the clinical trial, treat a study
p.000012: participant if it is in the interest of the study participant.
p.000012:
p.000012: Periodic reports to the SCOCT
p.000012: 41. The SCOCT may require the holder of an approval during a clinical trial to provide any information
p.000012: or report at such times and in such manner as the SCOCT may require.
p.000012: 42. The holder of an approval should submit to the SCOCT a final report of the clinical trial within
p.000012: six (06) months after the completion of the trial or such longer period as the SCOCT may allow.
p.000012: In case a clinical trial is prematurely discontinued for any reason a summary report should be submitted within three
p.000012: (03) months. This report should provide a brief description of the study, number of participants exposed to
p.000012: the drug, dose and duration of such exposure, details of adverse reactions, if any, and reason(s) for discontinuation.
p.000012:
p.000012: Notification of serious adverse events & SUSARs
p.000012: 43. The investigator(s) should report all serious adverse events (SAEs) immediately to the sponsor except
p.000012: for those SAEs the protocol or investigator’s brochure identifies as not requiring immediate reporting.
p.000012: The immediate reports should be followed promptly by detailed, written reports. All SAEs occurring at trial
p.000012: sites in Sri Lanka should be reported as soon as possible to the SCOCT and the relevant Ethics Review Committee by the
p.000012: sponsor.
p.000012: 44. A "serious adverse event" means any unfavourable and unintended sign (including an abnormal laboratory
p.000012: finding), symptom or disease, whether or not caused by the use of the test material, which;
p.000012: (a) results in death,
p.000012:
p.000012: (b) is life-threatening,
p.000012:
p.000012: (c) requires in-patient hospitalization or prolongation of existing hospitalization,
p.000012:
p.000012: (d) results in persistent or significant disability or incapacity, or
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p.000012: (e) causes any congenital anomaly or birth defect.
p.000012:
p.000012: 45. All adverse drug reactions that are both serious and unexpected (SUSAR) are subject to expedited
p.000012: reporting. The principal investigator(s) should report all serious and unexpected adverse drug reactions
p.000012: occurring during a clinical trial to the sponsor as soon as possible, but
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 8 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
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p.000012: no later than twenty four hours after he was first aware of the reaction. The sponsor should report any serious
p.000012: unexpected adverse drug reaction (as defined in the Good Clinical Practices (GCP) Guidelines of the World Health
p.000012: Organization) in CIOMS-I format as soon as possible, but no later than fifteen calendar days after the sponsor was
p.000012: first aware of such reaction to the SCOCT, the relevant Ethics Review Committee and the investigator(s)
p.000012: participating in the clinical trial. Any fatal or life-threatening serious unexpected adverse drug reaction should be
p.000012: reported by the sponsor to the SCOCT, the relevant Ethics Review Committee and the investigators
p.000012: participating in the clinical trial as soon as possible, but no later than seven calendar days after the
p.000012: sponsor was first aware of such reaction. All serious and unexpected adverse drug reactions related to the same
p.000012: investigational product reported from all sites involved with the same trial protocol driven clinical trial,
p.000012: should be reported with a causality statement by sponsor to the SCOCT and the relevant Ethics Review Committee that
p.000012: accorded approval to the trial protocol in the form of quarterly line listed reports.
p.000012:
p.000012: Test material particulars, identification and storage
p.000012: 46. The sponsor must ensure that the investigational product(s), including active comparator(s) and placebo
p.000012: if applicable, is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice
p.000012: (GMP) for medicinal products of the WHO or similar accreditation body.
p.000012: 47. The sponsor must ensure that the product label on outer packaging of investigational medicinal
p.000012: product(s) or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English, which should include the following:
p.000012: (a) The reference number or other unique identification mark of each item of such material
p.000012:
p.000012: (b) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere
p.000012: (c) The date of manufacture and the expiry date of the test material
p.000012:
p.000012: (d) The storage conditions appropriate for each item of test material as may be indicated by the manufacturer, and
p.000012: (e) The words: "For Clinical Trial Use Only" or similar wording
p.000012:
p.000012: (f) Period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in
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p.000012: (d) signed by other parties such as local coordinator where relevant.
p.000012:
p.000012: Duty to comply with guidelines and instructions of SCOCT
p.000012: 60. Every sponsor, principal investigator or holder of an approval must comply with all
p.000012: guidelines or instructions relating to the conduct of clinical trials issued by the SCOCT.
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p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 11 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: Glossary
p.000012:
p.000012:
p.000012: “Adverse Event (AE)” means any untoward medical occurrence in a patient or clinical investigation subject
p.000012: administered a medicinal product and which does not necessarily have a causal relationship with this
p.000012: treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
p.000012: laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product,
p.000012: whether or not considered related to the medicinal (investigational) product;
p.000012: “Adverse Drug Reaction (ADR)” means a response to a pharmaceutical product that is noxious and unintended
p.000012: and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or
p.000012: for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse
p.000012: or dependence and interactions with any other product should be considered adverse reactions.
p.000012: “CIOMS-I format” means a format for reporting adverse drug reactions according to the Council of International
p.000012: Organizations for Medical Sciences.
p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
p.000012: or more health-related interventions to evaluate the effects on health outcomes. Interventions may include
p.000012: but are not restricted to substances such as drugs, cells and other biological products, vaccines,
p.000012: surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms
p.000012: “clinical trial” and “clinical study” are synonymous;
p.000012: “Contract research organization (CRO)” means a scientific organization (commercial, academic or other) to
p.000012: which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
p.000012: protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics
p.000012: review committees should be constituted and operated so that their tasks can be executed free from bias and from any
p.000012: influence of those who are conducting the trial.
p.000012: “Final report” means a comprehensive description of the trial after its completion including a description of
p.000012: experimental methods (including statistical methods) and materials, a presentation and evaluation of
p.000012: the results, statistical analyses and a critical, ethical, statistical and clinical appraisal
p.000012: “Good Clinical Practice (GCP) Guidelines” means identified ethical and scientific quality requirements which are
p.000012: internationally recognized and which must be observed for designing, conducting, recording and reporting clinical
p.000012: trials that involve the participation of human subjects. Compliance with GCP provides assurance that the
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 12 of 15
p.000012:
...
p.000012: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
p.000012: the purpose of determining the short and long-term safety/efficacy balance of formulation(s) of the active
p.000012: ingredient, and of assessing its overall and relative therapeutic value. The pattern and profile of any
p.000012: frequent adverse reactions must be investigated and special features of the product must be explored (e.g.
p.000012: clinically-relevant drug interactions, factors leading to differences in effect such as age).
p.000012: These trials should preferably be of a randomized double-blind design, but other designs may be acceptable, e.g.
p.000012: long-term safety studies. Generally, the conditions under which these trials are carried out should be as
p.000012: close as possible to normal conditions of use.
p.000012: “Phase IV clinical trials” Studies performed after marketing of the pharmaceutical product. Trials in phase IV are
p.000012: carried out on the basis of the product characteristics on which the marketing authorization was granted
p.000012: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value or
p.000012: treatment strategies. Although methods may differ, these studies should use the same scientific and ethical
p.000012: standards as applied in premarketing studies. After a product has been placed on the market, clinical trials designed
p.000012: to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials
p.000012: for new pharmaceutical products.
p.000012: "Principal Investigator (PI)" means a doctor or dentist, as the case may be, having specialized in the
p.000012: area of study and specified in an approval as the person responsible for the conduct and supervision of a
p.000012: clinical trial.
p.000012: “Protocol” means a document that states the background, rationale and objectives of the trial and
p.000012: describes its design, methodology and organization, including statistical considerations, and the conditions
p.000012: under which it is to be performed and managed. The protocol should be dated and signed by the investigator,
...
p.000012: defect.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 14 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Sponsor” means an individual, a company, an institution or an organization which takes responsibility for the
p.000012: initiation, management and/or financing of a clinical trial. When an investigator initiates and takes
p.000012: full responsibility for a trial, the investigator then also assumes the role of the sponsor.
p.000012:
p.000012: “Standard operating procedure (SOP)” means standard, detailed, written instructions for the management of
p.000012: clinical trials. They provide a general framework enabling the efficient implementation and performance of all the
p.000012: functions and activities for a particular trial as described in this document.
p.000012:
p.000012: “Study participant” means an individual who participates in a clinical trial, either as a recipient of
p.000012: the investigational product under investigation or as a control. The individual may be a healthy person
p.000012: who volunteers to participate in a trial, a person with a condition unrelated to the use of the
p.000012: investigational product, a person (usually a patient) whose condition is relevant to the use of
p.000012: the investigational product.
p.000012:
p.000012: “Unexpected adverse drug reaction” means an adverse reaction, the nature or severity of which is not consistent
p.000012: with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational
p.000012: medicinal product).
p.000012:
p.000012: “Witness” means person who will not be influenced in any way by those who are involved in the clinical trial, who is
p.000012: present and may provide assistance if required when the participant’s informed consent is obtained, and documents
p.000012: that this consent is given freely by signing and dating the informed consent form.
p.000012:
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p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
...
Searching for indicator influence:
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p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
p.000012: or more health-related interventions to evaluate the effects on health outcomes. Interventions may include
p.000012: but are not restricted to substances such as drugs, cells and other biological products, vaccines,
p.000012: surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms
p.000012: “clinical trial” and “clinical study” are synonymous;
p.000012: “Contract research organization (CRO)” means a scientific organization (commercial, academic or other) to
p.000012: which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
p.000012: protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics
p.000012: review committees should be constituted and operated so that their tasks can be executed free from bias and from any
p.000012: influence of those who are conducting the trial.
p.000012: “Final report” means a comprehensive description of the trial after its completion including a description of
p.000012: experimental methods (including statistical methods) and materials, a presentation and evaluation of
p.000012: the results, statistical analyses and a critical, ethical, statistical and clinical appraisal
p.000012: “Good Clinical Practice (GCP) Guidelines” means identified ethical and scientific quality requirements which are
p.000012: internationally recognized and which must be observed for designing, conducting, recording and reporting clinical
p.000012: trials that involve the participation of human subjects. Compliance with GCP provides assurance that the
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 12 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: rights, safety, and well-being of trial subjects are protected, and the results of the clinical trials are credible;
p.000012: “Good Manufacturing Practice (GMP)” means that part of pharmaceutical quality assurance which ensures
p.000012: that products are consistently produced and controlled to the quality standards appropriate to their intended
p.000012: use and as required by the marketing authorization. In these guidelines, GMP refers to the current GMP
p.000012: Guidelines published by WHO.
p.000012: “Informed consent” means voluntary written assent of a study subject’s willingness to participate in a
...
Searching for indicator substance:
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p.000012: reference in a clinical trial.
p.000012: “Investigational product labeling’ means labeling developed specifically for products involved in a clinical
p.000012: trial
p.000012: “Investigator" means a doctor or dentist, as the case may be, responsible for the conduct of the clinical trial and for
p.000012: the rights, health and welfare of the participants in the trial at a trial site. If a trial is conducted by a
p.000012: team of individuals at a trial site, the investigator is the responsible leader of the team and may be called
p.000012: the principal investigator;
p.000012: “Investigator’s Brochure” means A collection of data for the investigator consisting of all the relevant information
p.000012: on the investigational medicinal product(s), including chemical and pharmaceutical data and
p.000012: toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and
p.000012: the results of earlier clinical trials. There should be adequate data to justify the nature, scale and
p.000012: duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new
p.000012: data are generated, the investigator’s brochure must be updated.
p.000012: "Legal representative", in relation to a person who is to be used as a study subject in a clinical
p.000012: trial, means an individual or judicial or other body authorized under the law to grant consent on behalf of
p.000012: that person, to the participation of such person in the clinical trial;
p.000012: “Pharmaceutical product” means any substance or combination of substances which has a therapeutic, prophylactic or
p.000012: diagnostic use, or is intended to modify physiological functions, and is presented in a dosage form suitable for
p.000012: administration to humans.
p.000012: “Phase I clinical trials” mean the first trials of a new active ingredient or new formulations in man, often carried
p.000012: out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000012: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
...
Health / Healthy People
Searching for indicator volunteers:
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p.000012: team of individuals at a trial site, the investigator is the responsible leader of the team and may be called
p.000012: the principal investigator;
p.000012: “Investigator’s Brochure” means A collection of data for the investigator consisting of all the relevant information
p.000012: on the investigational medicinal product(s), including chemical and pharmaceutical data and
p.000012: toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and
p.000012: the results of earlier clinical trials. There should be adequate data to justify the nature, scale and
p.000012: duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new
p.000012: data are generated, the investigator’s brochure must be updated.
p.000012: "Legal representative", in relation to a person who is to be used as a study subject in a clinical
p.000012: trial, means an individual or judicial or other body authorized under the law to grant consent on behalf of
p.000012: that person, to the participation of such person in the clinical trial;
p.000012: “Pharmaceutical product” means any substance or combination of substances which has a therapeutic, prophylactic or
p.000012: diagnostic use, or is intended to modify physiological functions, and is presented in a dosage form suitable for
p.000012: administration to humans.
p.000012: “Phase I clinical trials” mean the first trials of a new active ingredient or new formulations in man, often carried
p.000012: out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000012: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
p.000012: the purpose of determining the short and long-term safety/efficacy balance of formulation(s) of the active
p.000012: ingredient, and of assessing its overall and relative therapeutic value. The pattern and profile of any
p.000012: frequent adverse reactions must be investigated and special features of the product must be explored (e.g.
...
p.000012: “Serious Adverse Event (SAE)” or “Serious Adverse Reaction (SAR)” means any untoward medical occurrence that at
p.000012: any dose results in death, is life- threatening, requires inpatient hospitalisation or prolongation of
p.000012: existing hospitalisation, results in persistent or significant disability/incapacity, or a congenital anomaly/birth
p.000012: defect.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 14 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Sponsor” means an individual, a company, an institution or an organization which takes responsibility for the
p.000012: initiation, management and/or financing of a clinical trial. When an investigator initiates and takes
p.000012: full responsibility for a trial, the investigator then also assumes the role of the sponsor.
p.000012:
p.000012: “Standard operating procedure (SOP)” means standard, detailed, written instructions for the management of
p.000012: clinical trials. They provide a general framework enabling the efficient implementation and performance of all the
p.000012: functions and activities for a particular trial as described in this document.
p.000012:
p.000012: “Study participant” means an individual who participates in a clinical trial, either as a recipient of
p.000012: the investigational product under investigation or as a control. The individual may be a healthy person
p.000012: who volunteers to participate in a trial, a person with a condition unrelated to the use of the
p.000012: investigational product, a person (usually a patient) whose condition is relevant to the use of
p.000012: the investigational product.
p.000012:
p.000012: “Unexpected adverse drug reaction” means an adverse reaction, the nature or severity of which is not consistent
p.000012: with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational
p.000012: medicinal product).
p.000012:
p.000012: “Witness” means person who will not be influenced in any way by those who are involved in the clinical trial, who is
p.000012: present and may provide assistance if required when the participant’s informed consent is obtained, and documents
p.000012: that this consent is given freely by signing and dating the informed consent form.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
...
p.000012: 42. The holder of an approval should submit to the SCOCT a final report of the clinical trial within
p.000012: six (06) months after the completion of the trial or such longer period as the SCOCT may allow.
p.000012: In case a clinical trial is prematurely discontinued for any reason a summary report should be submitted within three
p.000012: (03) months. This report should provide a brief description of the study, number of participants exposed to
p.000012: the drug, dose and duration of such exposure, details of adverse reactions, if any, and reason(s) for discontinuation.
p.000012:
p.000012: Notification of serious adverse events & SUSARs
p.000012: 43. The investigator(s) should report all serious adverse events (SAEs) immediately to the sponsor except
p.000012: for those SAEs the protocol or investigator’s brochure identifies as not requiring immediate reporting.
p.000012: The immediate reports should be followed promptly by detailed, written reports. All SAEs occurring at trial
p.000012: sites in Sri Lanka should be reported as soon as possible to the SCOCT and the relevant Ethics Review Committee by the
p.000012: sponsor.
p.000012: 44. A "serious adverse event" means any unfavourable and unintended sign (including an abnormal laboratory
p.000012: finding), symptom or disease, whether or not caused by the use of the test material, which;
p.000012: (a) results in death,
p.000012:
p.000012: (b) is life-threatening,
p.000012:
p.000012: (c) requires in-patient hospitalization or prolongation of existing hospitalization,
p.000012:
p.000012: (d) results in persistent or significant disability or incapacity, or
p.000012:
p.000012: (e) causes any congenital anomaly or birth defect.
p.000012:
p.000012: 45. All adverse drug reactions that are both serious and unexpected (SUSAR) are subject to expedited
p.000012: reporting. The principal investigator(s) should report all serious and unexpected adverse drug reactions
p.000012: occurring during a clinical trial to the sponsor as soon as possible, but
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 8 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: no later than twenty four hours after he was first aware of the reaction. The sponsor should report any serious
p.000012: unexpected adverse drug reaction (as defined in the Good Clinical Practices (GCP) Guidelines of the World Health
p.000012: Organization) in CIOMS-I format as soon as possible, but no later than fifteen calendar days after the sponsor was
p.000012: first aware of such reaction to the SCOCT, the relevant Ethics Review Committee and the investigator(s)
p.000012: participating in the clinical trial. Any fatal or life-threatening serious unexpected adverse drug reaction should be
p.000012: reported by the sponsor to the SCOCT, the relevant Ethics Review Committee and the investigators
...
p.000012: “Phase IV clinical trials” Studies performed after marketing of the pharmaceutical product. Trials in phase IV are
p.000012: carried out on the basis of the product characteristics on which the marketing authorization was granted
p.000012: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value or
p.000012: treatment strategies. Although methods may differ, these studies should use the same scientific and ethical
p.000012: standards as applied in premarketing studies. After a product has been placed on the market, clinical trials designed
p.000012: to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials
p.000012: for new pharmaceutical products.
p.000012: "Principal Investigator (PI)" means a doctor or dentist, as the case may be, having specialized in the
p.000012: area of study and specified in an approval as the person responsible for the conduct and supervision of a
p.000012: clinical trial.
p.000012: “Protocol” means a document that states the background, rationale and objectives of the trial and
p.000012: describes its design, methodology and organization, including statistical considerations, and the conditions
p.000012: under which it is to be performed and managed. The protocol should be dated and signed by the investigator,
p.000012: the institution involved and the sponsor. It can also function as a contract.
p.000012: “Serious Adverse Event (SAE)” or “Serious Adverse Reaction (SAR)” means any untoward medical occurrence that at
p.000012: any dose results in death, is life- threatening, requires inpatient hospitalisation or prolongation of
p.000012: existing hospitalisation, results in persistent or significant disability/incapacity, or a congenital anomaly/birth
p.000012: defect.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 14 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Sponsor” means an individual, a company, an institution or an organization which takes responsibility for the
p.000012: initiation, management and/or financing of a clinical trial. When an investigator initiates and takes
p.000012: full responsibility for a trial, the investigator then also assumes the role of the sponsor.
p.000012:
p.000012: “Standard operating procedure (SOP)” means standard, detailed, written instructions for the management of
p.000012: clinical trials. They provide a general framework enabling the efficient implementation and performance of all the
p.000012: functions and activities for a particular trial as described in this document.
p.000012:
p.000012: “Study participant” means an individual who participates in a clinical trial, either as a recipient of
p.000012: the investigational product under investigation or as a control. The individual may be a healthy person
p.000012: who volunteers to participate in a trial, a person with a condition unrelated to the use of the
p.000012: investigational product, a person (usually a patient) whose condition is relevant to the use of
p.000012: the investigational product.
p.000012:
...
Health / Physically Disabled
Searching for indicator illness:
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p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000012: Ministry of Health
p.000012: Page 5 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000012: sponsor should promptly notify other investigator(s) participating in the trial, the SCOCT and the relevant Ethics
p.000012: Review Committee of findings that could affect adversely the safety of study participants or impact the conduct of the
p.000012: trial.
p.000012: 21. The sponsor should ensure that the investigational medicinal products, including active comparators and
p.000012: placebo if applicable, is manufactured in accordance with the principles and guidelines of Good Manufacturing
p.000012: Practice (GMP) for medicinal products of the WHO or similar accreditation body.
p.000012: 22. The sponsor should ensure that the product label on outer packaging of investigational medicinal
p.000012: products or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English. Unused investigational product(s) should be returned to the
p.000012: sponsor or alternative disposition if authorized by the sponsor and in compliance with the applicable
p.000012: regulatory requirement(s).
p.000012: 23. The sponsor should ensure laboratories used for generating data for clinical trials should be compliant with Good
p.000012: Laboratory Practices.
p.000012:
p.000012: Responsibilities of investigator(s)
p.000012: 24. Every clinical trial should be conducted under the charge and supervision of a principal
p.000012: investigator. All trial investigator(s), including the principal investigator(s) should possess appropriate
p.000012: qualifications, training, and experience and should have access to such investigational and treatment
p.000012: facilities as are relevant to the trial protocol.
p.000012: 25. The investigator is responsible for the conduct of the trial according to the protocol and GCP Guidelines. The
p.000012: investigator is responsible for giving adequate information to the study participant in respect of the
p.000012: clinical trial in accordance with the GCP Guidelines of the World Health Organization. The investigator should
p.000012: have adequate resources and facilities for the foreseen duration of the trial to conduct the trial to these
p.000012: standards.
p.000012: 26. The investigator should ensure that adequate free medical care is provided to the study subject if there is a
p.000012: trial-related injury until such time as the study subject is completely recovered from the effects of
p.000012: such injury. The investigator should have at the time of applying for a clinical trial approval, entered
p.000012: into an agreement with the sponsor to ensure availability of finances for this purpose.
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 4 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: 27. The investigators should be familiar with the appropriate use of the investigational medicinal products, as
p.000012: described in the trial protocol, the investigator’s brochure, and in other sources of information provided by the
p.000012: sponsor. The investigator should ensure that all persons assisting with the trial are adequately informed about the
p.000012: protocol, investigational product(s), and their trial-related duties and functions.
...
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 6 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: (i) Any alternative procedures or treatments available to the participant, and their potential benefits and risks
p.000012: (j) Any compensation and free treatment available to the participant in the event of injury arising from
p.000012: participation in the clinical trial
p.000012: (k) Any anticipated expenses to the participant from participating in the clinical trial
p.000012:
p.000012: (l) Any pro-rated payment to the study participant for participating in the clinical trial
p.000012:
p.000012: (m) That participation in the clinical trial is voluntary and that the participant may refuse to participate in or may
p.000012: withdraw from the clinical trial at any time without penalty or loss of benefit, which the participant would otherwise
p.000012: be entitled
p.000012: (n) The persons who will be granted access to the subject's medical records and the extent of such access, including
p.000012: the possibility that the licensing authority may inspect the records
p.000012: (o) The extent to which records identifying the subject will be kept confidential
p.000012:
p.000012: (p) That the subject or his legally acceptable representative will be informed in a timely manner of
p.000012: any information becoming available which may be relevant to the participant's willingness to continue
p.000012: participating in the clinical trial
p.000012: (q) The persons to contact for further information relating to the clinical trial and the rights of participants and
p.000012: in the event of injury arising from participation in the clinical trial
p.000012: (r) Sponsorship, if any, with name of sponsor, any interests or conflicts of interest declared by the investigators,
p.000012: and name/contact details of the Ethics Review Committee that gave approval to the trial
p.000012: (s) Any foreseeable circumstances under or reasons for which the participant's participation may be terminated
p.000012: (t) The expected duration of the participant's participation in the clinical trial
p.000012:
p.000012: (u) The approximate number of participants involved in the clinical trial
p.000012:
p.000012: (v) Any other information that the SCOCT may require to be given
p.000012:
p.000012: (w) Any other information which the study participant may request to know
p.000012:
p.000012: 36. If any information becomes available which may be relevant to a subject's willingness to continue
p.000012: participating in a clinical trial, the holder of an approval should, at the earliest feasible opportunity,
p.000012: give to the participant or his legally acceptable representative a full and reasonable explanation of that information.
...
Social / Age
Searching for indicator age:
(return to top)
p.000012:
p.000012: b) Substantialamendments to the protocol
p.000012:
p.000012: Substantial amendments to the conduct of the clinical trial may arise from changes to the protocol or from new
p.000012: information relating to the scientific documents in support of the trial. Amendments to the trial are regarded
p.000012: as “substantial” where they are likely to have a significant impact on: the safety or physical or mental
p.000012: integrity of the subjects, or the scientific value of the trial, or the conduct or management of the
p.000012: trial, or the quality or safety of any investigational medicinal products used in the trial.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 5 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
...
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
p.000012: the purpose of determining the short and long-term safety/efficacy balance of formulation(s) of the active
p.000012: ingredient, and of assessing its overall and relative therapeutic value. The pattern and profile of any
p.000012: frequent adverse reactions must be investigated and special features of the product must be explored (e.g.
p.000012: clinically-relevant drug interactions, factors leading to differences in effect such as age).
p.000012: These trials should preferably be of a randomized double-blind design, but other designs may be acceptable, e.g.
p.000012: long-term safety studies. Generally, the conditions under which these trials are carried out should be as
p.000012: close as possible to normal conditions of use.
p.000012: “Phase IV clinical trials” Studies performed after marketing of the pharmaceutical product. Trials in phase IV are
p.000012: carried out on the basis of the product characteristics on which the marketing authorization was granted
p.000012: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value or
p.000012: treatment strategies. Although methods may differ, these studies should use the same scientific and ethical
p.000012: standards as applied in premarketing studies. After a product has been placed on the market, clinical trials designed
p.000012: to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials
p.000012: for new pharmaceutical products.
p.000012: "Principal Investigator (PI)" means a doctor or dentist, as the case may be, having specialized in the
p.000012: area of study and specified in an approval as the person responsible for the conduct and supervision of a
p.000012: clinical trial.
p.000012: “Protocol” means a document that states the background, rationale and objectives of the trial and
p.000012: describes its design, methodology and organization, including statistical considerations, and the conditions
p.000012: under which it is to be performed and managed. The protocol should be dated and signed by the investigator,
p.000012: the institution involved and the sponsor. It can also function as a contract.
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 6 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: (i) Any alternative procedures or treatments available to the participant, and their potential benefits and risks
p.000012: (j) Any compensation and free treatment available to the participant in the event of injury arising from
p.000012: participation in the clinical trial
p.000012: (k) Any anticipated expenses to the participant from participating in the clinical trial
p.000012:
p.000012: (l) Any pro-rated payment to the study participant for participating in the clinical trial
p.000012:
p.000012: (m) That participation in the clinical trial is voluntary and that the participant may refuse to participate in or may
p.000012: withdraw from the clinical trial at any time without penalty or loss of benefit, which the participant would otherwise
p.000012: be entitled
p.000012: (n) The persons who will be granted access to the subject's medical records and the extent of such access, including
p.000012: the possibility that the licensing authority may inspect the records
p.000012: (o) The extent to which records identifying the subject will be kept confidential
p.000012:
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000012:
p.000012:
p.000012: Glossary
p.000012:
p.000012:
p.000012: “Adverse Event (AE)” means any untoward medical occurrence in a patient or clinical investigation subject
p.000012: administered a medicinal product and which does not necessarily have a causal relationship with this
p.000012: treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
p.000012: laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product,
p.000012: whether or not considered related to the medicinal (investigational) product;
p.000012: “Adverse Drug Reaction (ADR)” means a response to a pharmaceutical product that is noxious and unintended
p.000012: and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or
p.000012: for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse
p.000012: or dependence and interactions with any other product should be considered adverse reactions.
p.000012: “CIOMS-I format” means a format for reporting adverse drug reactions according to the Council of International
p.000012: Organizations for Medical Sciences.
p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
p.000012: or more health-related interventions to evaluate the effects on health outcomes. Interventions may include
p.000012: but are not restricted to substances such as drugs, cells and other biological products, vaccines,
p.000012: surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms
p.000012: “clinical trial” and “clinical study” are synonymous;
p.000012: “Contract research organization (CRO)” means a scientific organization (commercial, academic or other) to
p.000012: which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
p.000012: protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics
p.000012: review committees should be constituted and operated so that their tasks can be executed free from bias and from any
p.000012: influence of those who are conducting the trial.
p.000012: “Final report” means a comprehensive description of the trial after its completion including a description of
p.000012: experimental methods (including statistical methods) and materials, a presentation and evaluation of
p.000012: the results, statistical analyses and a critical, ethical, statistical and clinical appraisal
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 6 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: (i) Any alternative procedures or treatments available to the participant, and their potential benefits and risks
p.000012: (j) Any compensation and free treatment available to the participant in the event of injury arising from
p.000012: participation in the clinical trial
p.000012: (k) Any anticipated expenses to the participant from participating in the clinical trial
p.000012:
p.000012: (l) Any pro-rated payment to the study participant for participating in the clinical trial
p.000012:
p.000012: (m) That participation in the clinical trial is voluntary and that the participant may refuse to participate in or may
p.000012: withdraw from the clinical trial at any time without penalty or loss of benefit, which the participant would otherwise
p.000012: be entitled
p.000012: (n) The persons who will be granted access to the subject's medical records and the extent of such access, including
p.000012: the possibility that the licensing authority may inspect the records
p.000012: (o) The extent to which records identifying the subject will be kept confidential
p.000012:
p.000012: (p) That the subject or his legally acceptable representative will be informed in a timely manner of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000012:
p.000012: d) Recruitment of additional study participants
p.000012:
p.000012: Protocol amendments, which require prior approvalfrom the SCOCT and relevant Ethics Review Committee before
p.000012: implementation of the amendments:
p.000012: a) Change of Principal Investigator if he is the holder of the approval
p.000012:
p.000012: b) Substantialamendments to the protocol
p.000012:
p.000012: Substantial amendments to the conduct of the clinical trial may arise from changes to the protocol or from new
p.000012: information relating to the scientific documents in support of the trial. Amendments to the trial are regarded
p.000012: as “substantial” where they are likely to have a significant impact on: the safety or physical or mental
p.000012: integrity of the subjects, or the scientific value of the trial, or the conduct or management of the
p.000012: trial, or the quality or safety of any investigational medicinal products used in the trial.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 5 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000012: require only ethics approval and registration with the Sri Lanka Clinical Trials Registry.
p.000012:
p.000012: 3. Phase I / first-in-man clinical trials are not allowed in Sri Lanka at present.
p.000012:
p.000012: Phases II, III and IV clinical trials are allowed subject to the following condition:
p.000012: Phase II trials are allowed provided the same study protocol is approved in countries with reference
p.000012: regulatory authorities – USA, Canada, European countries governed by EMA, UK, Japan, Australia, New Zealand, and
p.000012: Singapore.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 1 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Application for approval to conduct a clinical trial
p.000012: 4. An application for permission to conduct a clinical trial must be made to the Sub-Committee on Clinical Trials
p.000012: (SCOCT), CDDRA, by a suitably qualified Principal Investigator (PI) or in the case of multi-centre studies
p.000012: involving many investigators, the Coordinating Principal Investigator or National Coordinator, who shall be
p.000012: registered with the Sri Lanka Medical Council and employed by/formally attached to the Ministry of Health, a
p.000012: recognized healthcare institution and/or university in Sri Lanka.
p.000012: 5. Where a clinical trial is conducted at multiple sites in Sri Lanka only a single application is required to be
p.000012: submitted to the SCOCT.
p.000012: 6. An application for permission to conduct a clinical trial should be made in triplicate to the
p.000012: Sub-Committee on Clinical Trials (SCOCT) of the CDDRA in the stipulated Application Form accompanied by a
p.000012: covering letter and the following essential documents:
p.000012: - Investigator’s brochure – containing chemical and pharmaceutical information, animal pharmacology &
p.000012: toxicology data, specific pharmacological actions, pharmacokinetic data, and available human clinical
p.000012: pharmacology data related to the investigational product(s)
p.000012: - Clinical trial protocol
p.000012:
p.000012: - Informed consent document(s) with Sinhala and Sri Lankan Tamil translations
p.000012:
p.000012: - Curriculum vitae of principal investigators
p.000012:
p.000012: - Undertaking by the principal investigators
p.000012:
p.000012: - Ethics review committee clearance, if clearance has already been granted
p.000012:
p.000012: - Regulatory status in other countries, if available, in case of international multi-centre studies
p.000012: - Current copy of certificate of Good Manufacturing Practices (GMP) & complete certificate of
p.000012: analysis
p.000012: - Valid insurance certificate with insurance cover in Sri Lanka
p.000012:
p.000012: - Any other information as the SCOCT may require
p.000012:
p.000012: 7. Overseas clinical research organizations and sponsors or their subsidiaries, affiliates, or branch
p.000012: offices in Sri Lanka may engage in commercially-sponsored clinical trial activities at healthcare institutions in
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 6 of 15
p.000012:
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 11 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: Glossary
p.000012:
p.000012:
p.000012: “Adverse Event (AE)” means any untoward medical occurrence in a patient or clinical investigation subject
p.000012: administered a medicinal product and which does not necessarily have a causal relationship with this
p.000012: treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
p.000012: laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product,
p.000012: whether or not considered related to the medicinal (investigational) product;
p.000012: “Adverse Drug Reaction (ADR)” means a response to a pharmaceutical product that is noxious and unintended
p.000012: and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or
p.000012: for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse
p.000012: or dependence and interactions with any other product should be considered adverse reactions.
p.000012: “CIOMS-I format” means a format for reporting adverse drug reactions according to the Council of International
p.000012: Organizations for Medical Sciences.
p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
p.000012: or more health-related interventions to evaluate the effects on health outcomes. Interventions may include
p.000012: but are not restricted to substances such as drugs, cells and other biological products, vaccines,
p.000012: surgical procedures, radiological procedures, or any other item claimed to have therapeutic benefit. The terms
p.000012: “clinical trial” and “clinical study” are synonymous;
p.000012: “Contract research organization (CRO)” means a scientific organization (commercial, academic or other) to
p.000012: which a sponsor may transfer some of its tasks and obligations. Any such transfer should be defined in
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000012: 27. The investigators should be familiar with the appropriate use of the investigational medicinal products, as
p.000012: described in the trial protocol, the investigator’s brochure, and in other sources of information provided by the
p.000012: sponsor. The investigator should ensure that all persons assisting with the trial are adequately informed about the
p.000012: protocol, investigational product(s), and their trial-related duties and functions.
p.000012: 28. The investigator should submit any information or reports including progress reports to the Sponsor,
p.000012: SCOCT and the relevant Ethics Review Committee at such times as may be required by the Sponsor, SCOCT or the relevant
p.000012: Ethics Review Committee.
p.000012: 29. Where there is a change of principal investigator at a site during a clinical trial, the holder of an approval
p.000012: should forthwith notify the SCOCT of the change and should furnish particulars of the new principal investigator to the
p.000012: SCOCT and to the relevant Ethics Review Committee.
p.000012:
p.000012: Amendments to protocol & other trial-related documents
p.000012: 30. If amendment(s) to the trial protocol and other trial-related documents (e.g. investigator’s brochure,
p.000012: informed consent documents) become necessary before initiation or during the course of a clinical trial, all
p.000012: such amendments should be dealt with as outlined below:
p.000012: Protocol amendments, which do not require any communicationor approval from the SCOCT:
p.000012:
p.000012: a) Administrative and logistic changes
p.000012:
p.000012: b) Minor protocol amendments and additional safety assessments that have received
p.000012: approval from the relevant Ethics Review Committee
p.000012:
p.000012: Protocol amendments, which require to be informed to the SCOCT and the relevant Ethics Review Committee as
p.000012: notifications, but need not wait for approval:
p.000012: a) Inclusion of additional investigator sites
p.000012:
p.000012: b) Amendments that are made to the investigator’s brochure and resulting amendments to
p.000012: informed consent documents
p.000012:
p.000012: c) Change of principal investigator if he is not the holder of the approval
p.000012:
p.000012: d) Recruitment of additional study participants
p.000012:
p.000012: Protocol amendments, which require prior approvalfrom the SCOCT and relevant Ethics Review Committee before
p.000012: implementation of the amendments:
p.000012: a) Change of Principal Investigator if he is the holder of the approval
p.000012:
p.000012: b) Substantialamendments to the protocol
p.000012:
p.000012: Substantial amendments to the conduct of the clinical trial may arise from changes to the protocol or from new
p.000012: information relating to the scientific documents in support of the trial. Amendments to the trial are regarded
p.000012: as “substantial” where they are likely to have a significant impact on: the safety or physical or mental
p.000012: integrity of the subjects, or the scientific value of the trial, or the conduct or management of the
p.000012: trial, or the quality or safety of any investigational medicinal products used in the trial.
p.000012:
p.000012:
...
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 6 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: (i) Any alternative procedures or treatments available to the participant, and their potential benefits and risks
p.000012: (j) Any compensation and free treatment available to the participant in the event of injury arising from
p.000012: participation in the clinical trial
p.000012: (k) Any anticipated expenses to the participant from participating in the clinical trial
p.000012:
p.000012: (l) Any pro-rated payment to the study participant for participating in the clinical trial
p.000012:
p.000012: (m) That participation in the clinical trial is voluntary and that the participant may refuse to participate in or may
p.000012: withdraw from the clinical trial at any time without penalty or loss of benefit, which the participant would otherwise
p.000012: be entitled
p.000012: (n) The persons who will be granted access to the subject's medical records and the extent of such access, including
p.000012: the possibility that the licensing authority may inspect the records
p.000012: (o) The extent to which records identifying the subject will be kept confidential
p.000012:
...
Social / parents
Searching for indicator parent:
(return to top)
p.000012: integrity of the subjects, or the scientific value of the trial, or the conduct or management of the
p.000012: trial, or the quality or safety of any investigational medicinal products used in the trial.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 5 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
p.000012: 33. Where a participant is not able to give informed consent (e.g. an unconscious person or a minor or
p.000012: those suffering from severe mental illness or disability), assent may be obtained from a legally acceptable
p.000012: representative of that person (a legally acceptable representative is a person who is able to give consent for or
p.000012: authorize an intervention in the patient as provided by the law(s) of Sri Lanka). If the participant or
p.000012: his/her legally acceptable representative is unable to read/write, an impartial witness should be present
p.000012: during the entire informed consent process who must attest all documents related to the informed consent process.
p.000012: 34. No person should, by means of any threat or coercion, compel or induce another person to be a participant in a
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
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p.000012: six (06) months after the completion of the trial or such longer period as the SCOCT may allow.
p.000012: In case a clinical trial is prematurely discontinued for any reason a summary report should be submitted within three
p.000012: (03) months. This report should provide a brief description of the study, number of participants exposed to
p.000012: the drug, dose and duration of such exposure, details of adverse reactions, if any, and reason(s) for discontinuation.
p.000012:
p.000012: Notification of serious adverse events & SUSARs
p.000012: 43. The investigator(s) should report all serious adverse events (SAEs) immediately to the sponsor except
p.000012: for those SAEs the protocol or investigator’s brochure identifies as not requiring immediate reporting.
p.000012: The immediate reports should be followed promptly by detailed, written reports. All SAEs occurring at trial
p.000012: sites in Sri Lanka should be reported as soon as possible to the SCOCT and the relevant Ethics Review Committee by the
p.000012: sponsor.
p.000012: 44. A "serious adverse event" means any unfavourable and unintended sign (including an abnormal laboratory
p.000012: finding), symptom or disease, whether or not caused by the use of the test material, which;
p.000012: (a) results in death,
p.000012:
p.000012: (b) is life-threatening,
p.000012:
p.000012: (c) requires in-patient hospitalization or prolongation of existing hospitalization,
p.000012:
p.000012: (d) results in persistent or significant disability or incapacity, or
p.000012:
p.000012: (e) causes any congenital anomaly or birth defect.
p.000012:
p.000012: 45. All adverse drug reactions that are both serious and unexpected (SUSAR) are subject to expedited
p.000012: reporting. The principal investigator(s) should report all serious and unexpected adverse drug reactions
p.000012: occurring during a clinical trial to the sponsor as soon as possible, but
p.000012:
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p.000012: no later than twenty four hours after he was first aware of the reaction. The sponsor should report any serious
p.000012: unexpected adverse drug reaction (as defined in the Good Clinical Practices (GCP) Guidelines of the World Health
p.000012: Organization) in CIOMS-I format as soon as possible, but no later than fifteen calendar days after the sponsor was
p.000012: first aware of such reaction to the SCOCT, the relevant Ethics Review Committee and the investigator(s)
p.000012: participating in the clinical trial. Any fatal or life-threatening serious unexpected adverse drug reaction should be
p.000012: reported by the sponsor to the SCOCT, the relevant Ethics Review Committee and the investigators
...
p.000012: carried out on the basis of the product characteristics on which the marketing authorization was granted
p.000012: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value or
p.000012: treatment strategies. Although methods may differ, these studies should use the same scientific and ethical
p.000012: standards as applied in premarketing studies. After a product has been placed on the market, clinical trials designed
p.000012: to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials
p.000012: for new pharmaceutical products.
p.000012: "Principal Investigator (PI)" means a doctor or dentist, as the case may be, having specialized in the
p.000012: area of study and specified in an approval as the person responsible for the conduct and supervision of a
p.000012: clinical trial.
p.000012: “Protocol” means a document that states the background, rationale and objectives of the trial and
p.000012: describes its design, methodology and organization, including statistical considerations, and the conditions
p.000012: under which it is to be performed and managed. The protocol should be dated and signed by the investigator,
p.000012: the institution involved and the sponsor. It can also function as a contract.
p.000012: “Serious Adverse Event (SAE)” or “Serious Adverse Reaction (SAR)” means any untoward medical occurrence that at
p.000012: any dose results in death, is life- threatening, requires inpatient hospitalisation or prolongation of
p.000012: existing hospitalisation, results in persistent or significant disability/incapacity, or a congenital anomaly/birth
p.000012: defect.
p.000012:
p.000012:
p.000012:
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p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Sponsor” means an individual, a company, an institution or an organization which takes responsibility for the
p.000012: initiation, management and/or financing of a clinical trial. When an investigator initiates and takes
p.000012: full responsibility for a trial, the investigator then also assumes the role of the sponsor.
p.000012:
p.000012: “Standard operating procedure (SOP)” means standard, detailed, written instructions for the management of
p.000012: clinical trials. They provide a general framework enabling the efficient implementation and performance of all the
p.000012: functions and activities for a particular trial as described in this document.
p.000012:
p.000012: “Study participant” means an individual who participates in a clinical trial, either as a recipient of
p.000012: the investigational product under investigation or as a control. The individual may be a healthy person
p.000012: who volunteers to participate in a trial, a person with a condition unrelated to the use of the
p.000012: investigational product, a person (usually a patient) whose condition is relevant to the use of
p.000012: the investigational product.
p.000012:
p.000012: “Unexpected adverse drug reaction” means an adverse reaction, the nature or severity of which is not consistent
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p.000012: give to the participant or his legally acceptable representative a full and reasonable explanation of that information.
p.000012: 37. If a person referred to in section 32 is used as a participant in a clinical trial and subsequently becomes
p.000012: capable of giving his own consent, the holder of an approval should, at the earliest feasible opportunity, give to
p.000012: that person a full and reasonable explanation of the matters referred to in section 34 and request his/her
p.000012: consent to continue to be used as a participant in the clinical trial.
p.000012:
p.000012:
p.000012:
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p.000012:
p.000012: 38. If a participant in a clinical trial refuses to give consent referred to in section 30, the principal investigator
p.000012: should immediately cease to use that person as a participant in the clinical trial.
p.000012:
p.000012: Participants to be treated by designated investigators
p.000012: 39. During the conduct of a clinical trial, no person, other than a holder of an approval, or a
p.000012: designated principal investigator approved by SCOCT, or any person assisting him in a clinical trial
p.000012: should treat a study participant or administer any test material to such study participant.
p.000012: 40. In an emergency, any doctor or dentist may, in the absence of the holder of an approval, or a designated
p.000012: principal investigator approved by SCOCT or any person assisting him in the clinical trial, treat a study
p.000012: participant if it is in the interest of the study participant.
p.000012:
p.000012: Periodic reports to the SCOCT
p.000012: 41. The SCOCT may require the holder of an approval during a clinical trial to provide any information
p.000012: or report at such times and in such manner as the SCOCT may require.
p.000012: 42. The holder of an approval should submit to the SCOCT a final report of the clinical trial within
p.000012: six (06) months after the completion of the trial or such longer period as the SCOCT may allow.
p.000012: In case a clinical trial is prematurely discontinued for any reason a summary report should be submitted within three
p.000012: (03) months. This report should provide a brief description of the study, number of participants exposed to
p.000012: the drug, dose and duration of such exposure, details of adverse reactions, if any, and reason(s) for discontinuation.
p.000012:
p.000012: Notification of serious adverse events & SUSARs
p.000012: 43. The investigator(s) should report all serious adverse events (SAEs) immediately to the sponsor except
p.000012: for those SAEs the protocol or investigator’s brochure identifies as not requiring immediate reporting.
p.000012: The immediate reports should be followed promptly by detailed, written reports. All SAEs occurring at trial
p.000012: sites in Sri Lanka should be reported as soon as possible to the SCOCT and the relevant Ethics Review Committee by the
p.000012: sponsor.
...
p.000012: 46. The sponsor must ensure that the investigational product(s), including active comparator(s) and placebo
p.000012: if applicable, is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice
p.000012: (GMP) for medicinal products of the WHO or similar accreditation body.
p.000012: 47. The sponsor must ensure that the product label on outer packaging of investigational medicinal
p.000012: product(s) or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English, which should include the following:
p.000012: (a) The reference number or other unique identification mark of each item of such material
p.000012:
p.000012: (b) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere
p.000012: (c) The date of manufacture and the expiry date of the test material
p.000012:
p.000012: (d) The storage conditions appropriate for each item of test material as may be indicated by the manufacturer, and
p.000012: (e) The words: "For Clinical Trial Use Only" or similar wording
p.000012:
p.000012: (f) Period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in
p.000012: a manner that avoids any ambiguity
p.000012: 48. No test material should be used in a clinical trial if the container in which the test material is stored is not
p.000012: marked and labeled with the particulars specified in section 47.
p.000012: 49. If any code or cipher is used in the labeling of a test material, the key to the code or cipher should be made
p.000012: available to any doctor or dentist in an emergency and it should be made known to the SCOCT.
p.000012: 50. The Sponsor should ensure all investigational medicinal products are stored in such manner as to be easily
p.000012: identifiable. If the investigational medicinal products cannot be identified, such investigational medicinal
p.000012: products should not be used and should be surrendered to the CDDRA.
p.000012:
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p.000012: Ministry of Health
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p.000012:
p.000012:
p.000012: 51. The sponsor should ensure that written procedures include instructions that the
p.000012: investigator/institution should follow for the handling and storage of investigational product(s).
p.000012: The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of
p.000012: unused product from study participant, and return of unused investigational product(s) to the sponsor
p.000012: or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory
p.000012: requirement(s).
p.000012:
p.000012: Records of clinical trials
p.000012: 52. The sponsor or holder of an approval should keep adequate clinical records of each study participant
p.000012: for the duration of the clinical trial.
p.000012: 53. The sponsor or holder of an approval should ensure that such records are:
p.000012:
p.000012: (a) Available at all times for inspection by the SCOCT or any person or body authorized by the SCOCT in that behalf,
p.000012: and kept up to date at all times,
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p.000001: Guidelines for the conduct of clinical trials in Sri Lanka
p.000001:
p.000001: Sub-Committee on Clinical Trials Cosmetics Devices & Drugs Regulatory Authority
p.000001: Ministry of Health
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p.000001: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000001: Ministry of Health
p.000001: I
p.000001:
p.000001:
p.000001:
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p.000001:
p.000001:
p.000001:
p.000001:
p.000001: THESE GUIDELINES ARE ISSUED BY THE SUB-COMMITTEE ON CLINICAL TRIALS MINISTRY OF HEALTH
p.000001:
p.000001:
p.000001: [Version 1.0 - October 2014]
p.000001:
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p.000001: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000001: Ministry of Health
p.000001: II
p.000001:
p.000001:
p.000001:
p.000001: Introduction
p.000001:
p.000001: The importance of research and development in the attainment of national health, social and economic goals is well
p.000001: recognized. Clinical trials of therapeutic interventions following the principles of scientific
p.000001: experimentation that elucidate the efficacy and safety of such therapies form the basis of modern medicine
p.000001: by generating evidence to assess whether these treatments are of genuine benefit to our patients.
p.000001:
p.000001: The Ministry of Health has always been committed to providing support, guidance and regulatory oversight
p.000001: for the conduct of clinical trials useful to this country. As part of this effort to facilitate and regulate ethical
p.000001: and scientific clinical research, the Sub Committee on Clinical Trial (SCOCT) was established in January
p.000001: 2010 to provide regulatory oversight and issue relevant approvals and certificates required for the
p.000001: conduct of clinical trials in Sri Lanka. In line with this mandate, the SCOCT performs regulatory,
p.000001: coordinating and administrative functions for clinical research under the authority of the CDDRA in the Ministry of
p.000001: Health.
p.000001:
p.000001: The aim of this guidance document prepared by SCOCT is to provide comprehensive guidelines to assist
p.000001: clinicians, scientists, sponsors and research organizations to become familiar with the existing procedures and
p.000001: requirements for the conduct of clinical trials in Sri Lanka.
p.000001:
p.000001: These guidelines also indicate the order of the material to be submitted and the minimum
p.000001: requirements for conducting clinical trials. These guidelines are not intended as a comprehensive guide on
p.000001: Good Clinical Practice (GCP), and should be read in conjunction with relevant international GCP guidelines.
p.000001:
p.000001: One of the principal objectives of this guidance note is to help investigators better understand their
p.000001: responsibilities with respect to protecting human research participants and ensuring the integrity of the data from
p.000001: clinical investigations. This guidance note is also intended to clarify for investigators and sponsors the
p.000001: Regulatory Authority’s expectations concerning the investigator’s and sponsor’s responsibilities to
p.000001: protect the rights, safety, and welfare of research participants whilst conducting clinical research
p.000001: programmes to the highest international standards.
p.000001:
p.000001: Dr Amal Harsha de Silva Chairman
p.000001: Sub-Committee on Clinical Trials CDDRA, Ministry of Health
p.000001: Sri Lanka
p.000001:
p.000001:
p.000001: October 2014
p.000001:
p.000001:
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p.000001: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000001: Ministry of Health
p.000001: III
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Table of Contents
p.000001: Introduction
p.000001: III
p.000001: Approvals required to conduct a clinical trial
p.000001: 1
p.000001: Application for approval to conduct a clinical trial
p.000002: 2
p.000002: Issue or refusal to issue approval
p.000003: 3
p.000003: Suspension or revocation of an approval
p.000003: 3
p.000003: Import licenses for import of study material
p.000003: 3
p.000003: Responsibilities of sponsor
p.000003: 3
p.000003: Responsibilities of investigator(s)
p.000004: 4
p.000004: Amendments to protocol & other trial-related documents
p.000005: 5
p.000005: Consent required to use a person as a participant in a clinical trial
p.000006: 6
p.000006: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000006:
p.000006: 6
p.000006: Participants to be treated by designated investigators
p.000008: 8
p.000008: Periodic reports to the SCOCT
p.000008: 8
p.000008: Notification of serious adverse events & SUSARs
p.000008: 8
p.000008: Test material particulars, identification & storage
p.000009: 9
p.000009: Record of clinical trials
p.000010: 10
p.000010: Financial interest in clinical trial
p.000010: 10
p.000010: Clinical Trial Agreement
p.000010: 10
p.000010: Duty to comply with guidelines and instructions of SCOCT
p.000011: 11
p.000011: Glossary
p.000012: 12
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: IV
p.000012:
p.000012: Approvals required to conduct a clinical trial
p.000012: 1. A clinical trial may be initiated in Sri Lanka only after:
p.000012: a) Obtaining approval from the Sub-Committee on Clinical Trials (SCOCT), Cosmetics Devices & Drugs
p.000012: Regulatory Authority (CDDRA), Ministry of Health.
p.000012: b) Obtaining clearance from one of the following Ethics Review Committees (ERC), which are accredited by the
p.000012: Sub-Committee on Clinical Trials, CDDRA, Ministry of Health:
p.000012: - ERC, Faculty of Medicine, University of Colombo
p.000012: - ERC, Faculty of Medical Sciences, University of Sri Jayewardenepura
p.000012: - ERC, Faculty of Medicine, University of Peradeniya
p.000012: - ERC, Faculty of Medicine, University of Kelaniya
p.000012: - ERC, Faculty of Medicine, University of Ruhuna
p.000012: - ERC, Faculty of Medicine, University of Jaffna
p.000012: - ERC, Medical Research Institute, Colombo
p.000012: - ERC, Sri Lanka Medical Association, Colombo
p.000012: c) Obtaining approval or a no-objections certificate from the head(s) of the institution(s) of the trial site(s)
p.000012: (e.g. Director of a hospital).
p.000012: d) Registering the study in the Sri Lanka Clinical Trials Registry.
p.000012:
p.000012: Parallel submissions can be made to both the SCOCT and to the relevant ERC. However, SCOCT approval to
p.000012: conduct a clinical trial will be granted only after clearance from one of the ethics review committees listed under
p.000012: 1(b) above has been obtained for the trial.
p.000012:
p.000012: 2. Approval from the SCOCT is required to conduct a clinical trial for the following categories of medicines;
p.000012: a) Unregistered medicines, and
p.000012: b) Registered medicines where the proposed clinical trial is outside of the conditions of registration.
p.000012: These may include changes to:
p.000012: (i) indication(s) and clinical use
p.000012: (ii) target patient population(s)
p.000012: (iii) route(s) of administration
p.000012: (iv) dosage regimen(s)
p.000012:
p.000012: Clinical trials for other categories of medicines sponsored by non-commercial sponsors such as investigators either as
p.000012: individuals or collaborative groups, academic institutions, healthcare institutions and cooperative establishments
p.000012: are not subject to regulatory review and do not require approval from the SCOCT. Such clinical trials
p.000012: require only ethics approval and registration with the Sri Lanka Clinical Trials Registry.
p.000012:
p.000012: 3. Phase I / first-in-man clinical trials are not allowed in Sri Lanka at present.
p.000012:
p.000012: Phases II, III and IV clinical trials are allowed subject to the following condition:
p.000012: Phase II trials are allowed provided the same study protocol is approved in countries with reference
p.000012: regulatory authorities – USA, Canada, European countries governed by EMA, UK, Japan, Australia, New Zealand, and
p.000012: Singapore.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
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p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012: Application for approval to conduct a clinical trial
p.000012: 4. An application for permission to conduct a clinical trial must be made to the Sub-Committee on Clinical Trials
p.000012: (SCOCT), CDDRA, by a suitably qualified Principal Investigator (PI) or in the case of multi-centre studies
p.000012: involving many investigators, the Coordinating Principal Investigator or National Coordinator, who shall be
p.000012: registered with the Sri Lanka Medical Council and employed by/formally attached to the Ministry of Health, a
p.000012: recognized healthcare institution and/or university in Sri Lanka.
p.000012: 5. Where a clinical trial is conducted at multiple sites in Sri Lanka only a single application is required to be
p.000012: submitted to the SCOCT.
p.000012: 6. An application for permission to conduct a clinical trial should be made in triplicate to the
p.000012: Sub-Committee on Clinical Trials (SCOCT) of the CDDRA in the stipulated Application Form accompanied by a
p.000012: covering letter and the following essential documents:
p.000012: - Investigator’s brochure – containing chemical and pharmaceutical information, animal pharmacology &
p.000012: toxicology data, specific pharmacological actions, pharmacokinetic data, and available human clinical
p.000012: pharmacology data related to the investigational product(s)
p.000012: - Clinical trial protocol
p.000012:
p.000012: - Informed consent document(s) with Sinhala and Sri Lankan Tamil translations
p.000012:
p.000012: - Curriculum vitae of principal investigators
p.000012:
p.000012: - Undertaking by the principal investigators
p.000012:
p.000012: - Ethics review committee clearance, if clearance has already been granted
p.000012:
p.000012: - Regulatory status in other countries, if available, in case of international multi-centre studies
p.000012: - Current copy of certificate of Good Manufacturing Practices (GMP) & complete certificate of
p.000012: analysis
p.000012: - Valid insurance certificate with insurance cover in Sri Lanka
p.000012:
p.000012: - Any other information as the SCOCT may require
p.000012:
p.000012: 7. Overseas clinical research organizations and sponsors or their subsidiaries, affiliates, or branch
p.000012: offices in Sri Lanka may engage in commercially-sponsored clinical trial activities at healthcare institutions in
p.000012: Sri Lanka only under legal agreement with recognized Sri Lankan medical research organizations who have
p.000012: ongoing affiliations with a local university or Ministry of Health for the conduct of clinical research or upon
p.000012: entering into legal agreement with local universities or research institutions/units in the Ministry of
p.000012: Health or private healthcare institutions possessing prior approval by SCOCT or
p.000012: medical associations/professional medical bodies registered in Sri Lanka possessing the required knowledge
p.000012: and expertise in the field of such research, and should not engage in directly recruiting patients into
p.000012: clinical trials.
p.000012:
p.000012:
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p.000012: Ministry of Health
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p.000012:
p.000012: Issue or refusal to issue approval
p.000012: 8. The SCOCT will not issue an approval unless clearance from an Ethics Review Committee accredited by
p.000012: SCOCT (Section 1 of this Guideline) for the conduct of the relevant trial has been obtained and forwarded to the
p.000012: SCOCT along with its recommendation.
p.000012: 9. An approval to conduct a clinical trial issued by the SCOCT may be subject to such terms and conditions as the
p.000012: SCOCT may impose.
p.000012: 10. Every approval granted by the SCOCT may, unless it is cancelled earlier by the SCOCT, or the trial for which the
p.000012: approval had been issued is terminated early by the sponsor, be valid for a period of five years from the date of such
p.000012: approval.
p.000012: 11. If an extension to the period of validity of an approval is required the holder of an approval should make a
p.000012: request for such extension to SCOCT no less than 60 days before the expiry of initial approval.
p.000012: 12. An approval to conduct a clinical trial will be issued in the name of the applicant and the
p.000012: clinical trial should be conducted only at the site(s) specified in the approval.
p.000012: Suspension or revocation of an approval
p.000012:
p.000012: 13. The SCOCT may suspend or revoke an approval if it is satisfied that the holder of the approval
p.000012: has acted in contravention of the trial protocol, Good Clinical Practice Guidelines (GCP),or any condition
p.000012: subject to which the approval was issued. Where an approval is suspended or revoked the SCOCT will
p.000012: state its reasons for doing so, and the holder of an approval will be required to forthwith discontinue
p.000012: the clinical trial for which such approval was issued. Where a clinical trial is discontinued, the
p.000012: investigator(s) conducting the clinical trial should ensure study subjects are informed of such discontinuation and are
p.000012: referred to the best available standard of care in the country for the condition he has been treated for.
p.000012: 14. Any person aggrieved by such refusal, suspension or revocation may appeal to the CDDRA within 30 days, of
p.000012: receiving such notification.
p.000012: Import licenses for import of study material
p.000012: 15. Upon receiving approval for the conduct of a clinical trial from SCOCT, the holder of the approval
p.000012: may thereupon apply to the Medical Technology & Supplies (MT&S) Division, CDDRA, Ministry of Health, for an
p.000012: import license and other permits as may be necessary for the import of investigational medicinal products and other
p.000012: drugs and material required for the study.
p.000012: Responsibilities of sponsor
p.000012:
p.000012: 16. The Sponsor is responsible for implementing and maintaining quality assurance systems to ensure that
p.000012: the clinical trial is conducted and data generated, documented, and reported in compliance with the
p.000012: protocol and Good Clinical Practice (GCP) guidelines of the World Health Organization.
p.000012:
p.000012:
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p.000012: 17. The Sponsor is required to register the clinical trial, for which the sponsor is responsible for, in the Sri Lanka
p.000012: Clinical Trials Registry in addition to registration with any other clinical trial registry before initiating patient
p.000012: screening and recruitment.
p.000012: 18. The Sponsor is responsible for selecting investigator(s) to conduct the study. Each
p.000012: investigator should be qualified by training and experience and should have adequate resources to properly
p.000012: conduct the study for which the investigator is selected.
p.000012: 19. The Sponsor is required to submit a status report on the clinical trial to the SCOCT at the
p.000012: prescribed periodicity and a final report of the clinical trial within six months (06) after the completion of the
p.000012: trial or such further period as the SCOCT may allow. In case of premature discontinuation of studies for any reason, a
p.000012: summary report should be submitted within three
p.000012: (03) months of such discontinuation.
p.000012:
p.000012: 20. The sponsor is responsible for the ongoing safety evaluation of the investigational medicinal product(s). The
p.000012: sponsor should promptly notify other investigator(s) participating in the trial, the SCOCT and the relevant Ethics
p.000012: Review Committee of findings that could affect adversely the safety of study participants or impact the conduct of the
p.000012: trial.
p.000012: 21. The sponsor should ensure that the investigational medicinal products, including active comparators and
...
p.000012: regulatory requirement(s).
p.000012: 23. The sponsor should ensure laboratories used for generating data for clinical trials should be compliant with Good
p.000012: Laboratory Practices.
p.000012:
p.000012: Responsibilities of investigator(s)
p.000012: 24. Every clinical trial should be conducted under the charge and supervision of a principal
p.000012: investigator. All trial investigator(s), including the principal investigator(s) should possess appropriate
p.000012: qualifications, training, and experience and should have access to such investigational and treatment
p.000012: facilities as are relevant to the trial protocol.
p.000012: 25. The investigator is responsible for the conduct of the trial according to the protocol and GCP Guidelines. The
p.000012: investigator is responsible for giving adequate information to the study participant in respect of the
p.000012: clinical trial in accordance with the GCP Guidelines of the World Health Organization. The investigator should
p.000012: have adequate resources and facilities for the foreseen duration of the trial to conduct the trial to these
p.000012: standards.
p.000012: 26. The investigator should ensure that adequate free medical care is provided to the study subject if there is a
p.000012: trial-related injury until such time as the study subject is completely recovered from the effects of
p.000012: such injury. The investigator should have at the time of applying for a clinical trial approval, entered
p.000012: into an agreement with the sponsor to ensure availability of finances for this purpose.
p.000012:
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p.000012: 27. The investigators should be familiar with the appropriate use of the investigational medicinal products, as
p.000012: described in the trial protocol, the investigator’s brochure, and in other sources of information provided by the
p.000012: sponsor. The investigator should ensure that all persons assisting with the trial are adequately informed about the
p.000012: protocol, investigational product(s), and their trial-related duties and functions.
p.000012: 28. The investigator should submit any information or reports including progress reports to the Sponsor,
p.000012: SCOCT and the relevant Ethics Review Committee at such times as may be required by the Sponsor, SCOCT or the relevant
p.000012: Ethics Review Committee.
p.000012: 29. Where there is a change of principal investigator at a site during a clinical trial, the holder of an approval
p.000012: should forthwith notify the SCOCT of the change and should furnish particulars of the new principal investigator to the
p.000012: SCOCT and to the relevant Ethics Review Committee.
p.000012:
p.000012: Amendments to protocol & other trial-related documents
p.000012: 30. If amendment(s) to the trial protocol and other trial-related documents (e.g. investigator’s brochure,
p.000012: informed consent documents) become necessary before initiation or during the course of a clinical trial, all
p.000012: such amendments should be dealt with as outlined below:
...
p.000012:
p.000012: Protocol amendments, which require to be informed to the SCOCT and the relevant Ethics Review Committee as
p.000012: notifications, but need not wait for approval:
p.000012: a) Inclusion of additional investigator sites
p.000012:
p.000012: b) Amendments that are made to the investigator’s brochure and resulting amendments to
p.000012: informed consent documents
p.000012:
p.000012: c) Change of principal investigator if he is not the holder of the approval
p.000012:
p.000012: d) Recruitment of additional study participants
p.000012:
p.000012: Protocol amendments, which require prior approvalfrom the SCOCT and relevant Ethics Review Committee before
p.000012: implementation of the amendments:
p.000012: a) Change of Principal Investigator if he is the holder of the approval
p.000012:
p.000012: b) Substantialamendments to the protocol
p.000012:
p.000012: Substantial amendments to the conduct of the clinical trial may arise from changes to the protocol or from new
p.000012: information relating to the scientific documents in support of the trial. Amendments to the trial are regarded
p.000012: as “substantial” where they are likely to have a significant impact on: the safety or physical or mental
p.000012: integrity of the subjects, or the scientific value of the trial, or the conduct or management of the
p.000012: trial, or the quality or safety of any investigational medicinal products used in the trial.
p.000012:
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p.000012:
p.000012: Consent required to use a person as a participant in a clinical trial
p.000012: 31. In all clinical trials, a freely given, informed, written consent is required to be obtained from each study
p.000012: participant. The Investigator must provide information about the study verbally as well as using a patient
p.000012: information sheet, in a language that is non-technical and understandable to the study participant.
p.000012: 32. An investigator should not use a person as a participant in a clinical trial unless the following are satisfied:
p.000012: (a) In the case of a person of or above the age of 18 years, with the consent of that person
p.000012:
p.000012: (b) In the case of a person below the age of 18 years, with the consent of that person and;
p.000012:
p.000012: (i) that person's parent or guardian (if there is no parent) and
p.000012:
p.000012: (ii) If different from sub-paragraph (i) above, the legal representative of that person.
p.000012:
...
p.000012: clinical trial.
p.000012:
p.000012: Duty to give full explanation and information to the trial participant or person entitled to give proxy consent
p.000012: 35. Before a clinical trial is carried out or conducted, the principal investigator should give the
p.000012: participant and any person giving consent on behalf of the participant, a full and reasonable explanation of the
p.000012: following:
p.000012: (a) That the clinical trial involves research
p.000012:
p.000012: (b) The purpose of the clinical trial
p.000012:
p.000012: (c) The treatments to be administered in the clinical trial and the probability for random assignment of
p.000012: each treatment
p.000012: (d) The procedures to be followed in the clinical trial, including all invasive procedures
p.000012:
p.000012: (e) The responsibilities of the participant
p.000012:
p.000012: (f) The aspects of the clinical trial which are experimental
p.000012:
p.000012: (g) The reasonably foreseeable risks or inconveniences to the participant and, where applicable,
p.000012: to any embryo, foetus or nursing infant
p.000012: (h) The reasonably expected benefits, including whether there is any intended clinical benefit to the
p.000012: participant
p.000012:
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p.000012: (i) Any alternative procedures or treatments available to the participant, and their potential benefits and risks
p.000012: (j) Any compensation and free treatment available to the participant in the event of injury arising from
p.000012: participation in the clinical trial
p.000012: (k) Any anticipated expenses to the participant from participating in the clinical trial
p.000012:
p.000012: (l) Any pro-rated payment to the study participant for participating in the clinical trial
p.000012:
p.000012: (m) That participation in the clinical trial is voluntary and that the participant may refuse to participate in or may
p.000012: withdraw from the clinical trial at any time without penalty or loss of benefit, which the participant would otherwise
p.000012: be entitled
p.000012: (n) The persons who will be granted access to the subject's medical records and the extent of such access, including
p.000012: the possibility that the licensing authority may inspect the records
p.000012: (o) The extent to which records identifying the subject will be kept confidential
p.000012:
p.000012: (p) That the subject or his legally acceptable representative will be informed in a timely manner of
p.000012: any information becoming available which may be relevant to the participant's willingness to continue
p.000012: participating in the clinical trial
p.000012: (q) The persons to contact for further information relating to the clinical trial and the rights of participants and
p.000012: in the event of injury arising from participation in the clinical trial
p.000012: (r) Sponsorship, if any, with name of sponsor, any interests or conflicts of interest declared by the investigators,
p.000012: and name/contact details of the Ethics Review Committee that gave approval to the trial
p.000012: (s) Any foreseeable circumstances under or reasons for which the participant's participation may be terminated
p.000012: (t) The expected duration of the participant's participation in the clinical trial
p.000012:
p.000012: (u) The approximate number of participants involved in the clinical trial
p.000012:
p.000012: (v) Any other information that the SCOCT may require to be given
p.000012:
p.000012: (w) Any other information which the study participant may request to know
p.000012:
p.000012: 36. If any information becomes available which may be relevant to a subject's willingness to continue
p.000012: participating in a clinical trial, the holder of an approval should, at the earliest feasible opportunity,
p.000012: give to the participant or his legally acceptable representative a full and reasonable explanation of that information.
p.000012: 37. If a person referred to in section 32 is used as a participant in a clinical trial and subsequently becomes
p.000012: capable of giving his own consent, the holder of an approval should, at the earliest feasible opportunity, give to
p.000012: that person a full and reasonable explanation of the matters referred to in section 34 and request his/her
p.000012: consent to continue to be used as a participant in the clinical trial.
p.000012:
p.000012:
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p.000012: 38. If a participant in a clinical trial refuses to give consent referred to in section 30, the principal investigator
p.000012: should immediately cease to use that person as a participant in the clinical trial.
p.000012:
p.000012: Participants to be treated by designated investigators
p.000012: 39. During the conduct of a clinical trial, no person, other than a holder of an approval, or a
p.000012: designated principal investigator approved by SCOCT, or any person assisting him in a clinical trial
p.000012: should treat a study participant or administer any test material to such study participant.
p.000012: 40. In an emergency, any doctor or dentist may, in the absence of the holder of an approval, or a designated
p.000012: principal investigator approved by SCOCT or any person assisting him in the clinical trial, treat a study
p.000012: participant if it is in the interest of the study participant.
p.000012:
p.000012: Periodic reports to the SCOCT
p.000012: 41. The SCOCT may require the holder of an approval during a clinical trial to provide any information
p.000012: or report at such times and in such manner as the SCOCT may require.
p.000012: 42. The holder of an approval should submit to the SCOCT a final report of the clinical trial within
p.000012: six (06) months after the completion of the trial or such longer period as the SCOCT may allow.
p.000012: In case a clinical trial is prematurely discontinued for any reason a summary report should be submitted within three
...
p.000012: 43. The investigator(s) should report all serious adverse events (SAEs) immediately to the sponsor except
p.000012: for those SAEs the protocol or investigator’s brochure identifies as not requiring immediate reporting.
p.000012: The immediate reports should be followed promptly by detailed, written reports. All SAEs occurring at trial
p.000012: sites in Sri Lanka should be reported as soon as possible to the SCOCT and the relevant Ethics Review Committee by the
p.000012: sponsor.
p.000012: 44. A "serious adverse event" means any unfavourable and unintended sign (including an abnormal laboratory
p.000012: finding), symptom or disease, whether or not caused by the use of the test material, which;
p.000012: (a) results in death,
p.000012:
p.000012: (b) is life-threatening,
p.000012:
p.000012: (c) requires in-patient hospitalization or prolongation of existing hospitalization,
p.000012:
p.000012: (d) results in persistent or significant disability or incapacity, or
p.000012:
p.000012: (e) causes any congenital anomaly or birth defect.
p.000012:
p.000012: 45. All adverse drug reactions that are both serious and unexpected (SUSAR) are subject to expedited
p.000012: reporting. The principal investigator(s) should report all serious and unexpected adverse drug reactions
p.000012: occurring during a clinical trial to the sponsor as soon as possible, but
p.000012:
p.000012:
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p.000012: no later than twenty four hours after he was first aware of the reaction. The sponsor should report any serious
p.000012: unexpected adverse drug reaction (as defined in the Good Clinical Practices (GCP) Guidelines of the World Health
p.000012: Organization) in CIOMS-I format as soon as possible, but no later than fifteen calendar days after the sponsor was
p.000012: first aware of such reaction to the SCOCT, the relevant Ethics Review Committee and the investigator(s)
p.000012: participating in the clinical trial. Any fatal or life-threatening serious unexpected adverse drug reaction should be
p.000012: reported by the sponsor to the SCOCT, the relevant Ethics Review Committee and the investigators
p.000012: participating in the clinical trial as soon as possible, but no later than seven calendar days after the
p.000012: sponsor was first aware of such reaction. All serious and unexpected adverse drug reactions related to the same
p.000012: investigational product reported from all sites involved with the same trial protocol driven clinical trial,
p.000012: should be reported with a causality statement by sponsor to the SCOCT and the relevant Ethics Review Committee that
p.000012: accorded approval to the trial protocol in the form of quarterly line listed reports.
p.000012:
p.000012: Test material particulars, identification and storage
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p.000012: product(s) or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English, which should include the following:
p.000012: (a) The reference number or other unique identification mark of each item of such material
p.000012:
p.000012: (b) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere
p.000012: (c) The date of manufacture and the expiry date of the test material
p.000012:
p.000012: (d) The storage conditions appropriate for each item of test material as may be indicated by the manufacturer, and
p.000012: (e) The words: "For Clinical Trial Use Only" or similar wording
p.000012:
p.000012: (f) Period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in
p.000012: a manner that avoids any ambiguity
p.000012: 48. No test material should be used in a clinical trial if the container in which the test material is stored is not
p.000012: marked and labeled with the particulars specified in section 47.
p.000012: 49. If any code or cipher is used in the labeling of a test material, the key to the code or cipher should be made
p.000012: available to any doctor or dentist in an emergency and it should be made known to the SCOCT.
p.000012: 50. The Sponsor should ensure all investigational medicinal products are stored in such manner as to be easily
p.000012: identifiable. If the investigational medicinal products cannot be identified, such investigational medicinal
p.000012: products should not be used and should be surrendered to the CDDRA.
p.000012:
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p.000012:
p.000012: 51. The sponsor should ensure that written procedures include instructions that the
p.000012: investigator/institution should follow for the handling and storage of investigational product(s).
p.000012: The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of
p.000012: unused product from study participant, and return of unused investigational product(s) to the sponsor
p.000012: or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory
p.000012: requirement(s).
p.000012:
p.000012: Records of clinical trials
p.000012: 52. The sponsor or holder of an approval should keep adequate clinical records of each study participant
p.000012: for the duration of the clinical trial.
p.000012: 53. The sponsor or holder of an approval should ensure that such records are:
p.000012:
p.000012: (a) Available at all times for inspection by the SCOCT or any person or body authorized by the SCOCT in that behalf,
p.000012: and kept up to date at all times,
p.000012: (b) Kept at least for whichever of the following periods that expires later;
p.000012:
p.000012: (i) until there are no pending or contemplated marketing applications of the test material in Sri Lanka,
p.000012: (ii) two (02) years after the last approval of a marketing application for the test material in Sri Lanka,
p.000012: 54. Where the approval for clinical trial is withdrawn or clinical trial is discontinued records shall be maintained
p.000012: for two (02) years after such withdrawal or two (02) years after the SCOCT has been informed of the discontinuation of
p.000012: the clinical trial.
p.000012: 55. Where a clinical trial is completed, records relating to such clinical trial should be maintained for
p.000012: (a) Ten (10) years after the completion of the clinical trial, or
p.000012:
p.000012: (b) Such other period as the SCOCT may direct taking into consideration any additional information that is
p.000012: submitted to it.
p.000012:
p.000012: Financial interest in clinical trial
p.000012: 56. The holder of an approval or any person assisting him in a clinical trial or any participant in a clinical trial
p.000012: must not, directly or indirectly, have any financial interest in the business of the sponsor of the clinical trial.
p.000012: Clinical Trial Agreement
p.000012:
p.000012: 57. A Clinical Trial Agreement (CTA) is a contract, which describes an agreement between two or more
p.000012: persons/institutions that create an obligation to undertake, or refrain from undertaking, a
p.000012: particular action.
p.000012: 58. All commercially sponsored research carried out in Sri Lanka must have a fully executed contract
p.000012: otherwise known as a Clinical Trial Agreement (CTA) before the study starts. All parties must sign a
p.000012: written agreement that defines the scope of work and formalizes the understanding between the parties. This
p.000012: agreement must define the scope of work, establish
p.000012:
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p.000012:
p.000012: acceptable payment arrangements, and address important issues such as the right to publish research results,
p.000012: protection of confidential information, compensation in case of serious trial- related injury to study participants and
p.000012: circumstances for indemnification.
p.000012: 59. All CTAs for research projects to be conducted at healthcare institutions must be;
p.000012:
p.000012: (a) signed by an approved institutional signatory (e.g. Medical Director) or a no-objection certificate
p.000012: should be issued by the Head of such Institution, as the case may be,
p.000012: (b) signed by the relevant principal investigator,
p.000012:
p.000012: (c) signed by the sponsor of the study or designated person by the sponsor (e.g. CRO), and
p.000012:
p.000012: (d) signed by other parties such as local coordinator where relevant.
p.000012:
p.000012: Duty to comply with guidelines and instructions of SCOCT
p.000012: 60. Every sponsor, principal investigator or holder of an approval must comply with all
p.000012: guidelines or instructions relating to the conduct of clinical trials issued by the SCOCT.
p.000012:
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p.000012:
p.000012:
p.000012: Glossary
p.000012:
p.000012:
p.000012: “Adverse Event (AE)” means any untoward medical occurrence in a patient or clinical investigation subject
p.000012: administered a medicinal product and which does not necessarily have a causal relationship with this
p.000012: treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal
p.000012: laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product,
p.000012: whether or not considered related to the medicinal (investigational) product;
p.000012: “Adverse Drug Reaction (ADR)” means a response to a pharmaceutical product that is noxious and unintended
p.000012: and which occurs at doses normally used or tested in man for prophylaxis, diagnosis, or therapy of disease, or
p.000012: for the modification of physiological function. In clinical trials, injuries caused by overdosing, abuse
p.000012: or dependence and interactions with any other product should be considered adverse reactions.
p.000012: “CIOMS-I format” means a format for reporting adverse drug reactions according to the Council of International
p.000012: Organizations for Medical Sciences.
p.000012: “Clinical trial” means any research study that prospectively assigns human participants or groups of humans to one
...
p.000012: writing.
p.000012:
p.000012: “Drug” includes a group of drugs.
p.000012:
p.000012: “Ethics review committee” means an independent body (a review board or a committee, institutional,
p.000012: regional or national), constituted of medical professionals and non- medical members, whose responsibility it
p.000012: is to verify that the safety, integrity and human rights of the subjects participating in a particular trial are
p.000012: protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics
p.000012: review committees should be constituted and operated so that their tasks can be executed free from bias and from any
p.000012: influence of those who are conducting the trial.
p.000012: “Final report” means a comprehensive description of the trial after its completion including a description of
p.000012: experimental methods (including statistical methods) and materials, a presentation and evaluation of
p.000012: the results, statistical analyses and a critical, ethical, statistical and clinical appraisal
p.000012: “Good Clinical Practice (GCP) Guidelines” means identified ethical and scientific quality requirements which are
p.000012: internationally recognized and which must be observed for designing, conducting, recording and reporting clinical
p.000012: trials that involve the participation of human subjects. Compliance with GCP provides assurance that the
p.000012:
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p.000012:
p.000012: rights, safety, and well-being of trial subjects are protected, and the results of the clinical trials are credible;
p.000012: “Good Manufacturing Practice (GMP)” means that part of pharmaceutical quality assurance which ensures
p.000012: that products are consistently produced and controlled to the quality standards appropriate to their intended
p.000012: use and as required by the marketing authorization. In these guidelines, GMP refers to the current GMP
p.000012: Guidelines published by WHO.
p.000012: “Informed consent” means voluntary written assent of a study subject’s willingness to participate in a
p.000012: particular clinical trial and its documentation. Such consent shall be taken only after information about the clinical
p.000012: trial, including an explanation of its status as research, its objectives, potential benefits, risks and
p.000012: inconveniences, alternative treatment that may be available and the rights and responsibilities of the study subject
p.000012: has been provided to the potential study subject;
p.000012: “Investigational medicinal product” means any pharmaceutical product or placebo being tested or used as a
p.000012: reference in a clinical trial.
p.000012: “Investigational product labeling’ means labeling developed specifically for products involved in a clinical
p.000012: trial
p.000012: “Investigator" means a doctor or dentist, as the case may be, responsible for the conduct of the clinical trial and for
...
p.000012: on the investigational medicinal product(s), including chemical and pharmaceutical data and
p.000012: toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and
p.000012: the results of earlier clinical trials. There should be adequate data to justify the nature, scale and
p.000012: duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new
p.000012: data are generated, the investigator’s brochure must be updated.
p.000012: "Legal representative", in relation to a person who is to be used as a study subject in a clinical
p.000012: trial, means an individual or judicial or other body authorized under the law to grant consent on behalf of
p.000012: that person, to the participation of such person in the clinical trial;
p.000012: “Pharmaceutical product” means any substance or combination of substances which has a therapeutic, prophylactic or
p.000012: diagnostic use, or is intended to modify physiological functions, and is presented in a dosage form suitable for
p.000012: administration to humans.
p.000012: “Phase I clinical trials” mean the first trials of a new active ingredient or new formulations in man, often carried
p.000012: out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000012: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
p.000012: the purpose of determining the short and long-term safety/efficacy balance of formulation(s) of the active
p.000012: ingredient, and of assessing its overall and relative therapeutic value. The pattern and profile of any
p.000012: frequent adverse reactions must be investigated and special features of the product must be explored (e.g.
p.000012: clinically-relevant drug interactions, factors leading to differences in effect such as age).
p.000012: These trials should preferably be of a randomized double-blind design, but other designs may be acceptable, e.g.
p.000012: long-term safety studies. Generally, the conditions under which these trials are carried out should be as
...
p.000012: treatment strategies. Although methods may differ, these studies should use the same scientific and ethical
p.000012: standards as applied in premarketing studies. After a product has been placed on the market, clinical trials designed
p.000012: to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials
p.000012: for new pharmaceutical products.
p.000012: "Principal Investigator (PI)" means a doctor or dentist, as the case may be, having specialized in the
p.000012: area of study and specified in an approval as the person responsible for the conduct and supervision of a
p.000012: clinical trial.
p.000012: “Protocol” means a document that states the background, rationale and objectives of the trial and
p.000012: describes its design, methodology and organization, including statistical considerations, and the conditions
p.000012: under which it is to be performed and managed. The protocol should be dated and signed by the investigator,
p.000012: the institution involved and the sponsor. It can also function as a contract.
p.000012: “Serious Adverse Event (SAE)” or “Serious Adverse Reaction (SAR)” means any untoward medical occurrence that at
p.000012: any dose results in death, is life- threatening, requires inpatient hospitalisation or prolongation of
p.000012: existing hospitalisation, results in persistent or significant disability/incapacity, or a congenital anomaly/birth
p.000012: defect.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 14 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Sponsor” means an individual, a company, an institution or an organization which takes responsibility for the
p.000012: initiation, management and/or financing of a clinical trial. When an investigator initiates and takes
p.000012: full responsibility for a trial, the investigator then also assumes the role of the sponsor.
p.000012:
p.000012: “Standard operating procedure (SOP)” means standard, detailed, written instructions for the management of
p.000012: clinical trials. They provide a general framework enabling the efficient implementation and performance of all the
p.000012: functions and activities for a particular trial as described in this document.
p.000012:
p.000012: “Study participant” means an individual who participates in a clinical trial, either as a recipient of
p.000012: the investigational product under investigation or as a control. The individual may be a healthy person
p.000012: who volunteers to participate in a trial, a person with a condition unrelated to the use of the
p.000012: investigational product, a person (usually a patient) whose condition is relevant to the use of
p.000012: the investigational product.
p.000012:
p.000012: “Unexpected adverse drug reaction” means an adverse reaction, the nature or severity of which is not consistent
p.000012: with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational
p.000012: medicinal product).
p.000012:
p.000012: “Witness” means person who will not be influenced in any way by those who are involved in the clinical trial, who is
p.000012: present and may provide assistance if required when the participant’s informed consent is obtained, and documents
p.000012: that this consent is given freely by signing and dating the informed consent form.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000012: Ministry of Health
p.000012: Page 3 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: 17. The Sponsor is required to register the clinical trial, for which the sponsor is responsible for, in the Sri Lanka
p.000012: Clinical Trials Registry in addition to registration with any other clinical trial registry before initiating patient
p.000012: screening and recruitment.
p.000012: 18. The Sponsor is responsible for selecting investigator(s) to conduct the study. Each
p.000012: investigator should be qualified by training and experience and should have adequate resources to properly
p.000012: conduct the study for which the investigator is selected.
p.000012: 19. The Sponsor is required to submit a status report on the clinical trial to the SCOCT at the
p.000012: prescribed periodicity and a final report of the clinical trial within six months (06) after the completion of the
p.000012: trial or such further period as the SCOCT may allow. In case of premature discontinuation of studies for any reason, a
p.000012: summary report should be submitted within three
p.000012: (03) months of such discontinuation.
p.000012:
p.000012: 20. The sponsor is responsible for the ongoing safety evaluation of the investigational medicinal product(s). The
p.000012: sponsor should promptly notify other investigator(s) participating in the trial, the SCOCT and the relevant Ethics
p.000012: Review Committee of findings that could affect adversely the safety of study participants or impact the conduct of the
p.000012: trial.
p.000012: 21. The sponsor should ensure that the investigational medicinal products, including active comparators and
p.000012: placebo if applicable, is manufactured in accordance with the principles and guidelines of Good Manufacturing
p.000012: Practice (GMP) for medicinal products of the WHO or similar accreditation body.
p.000012: 22. The sponsor should ensure that the product label on outer packaging of investigational medicinal
p.000012: products or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English. Unused investigational product(s) should be returned to the
p.000012: sponsor or alternative disposition if authorized by the sponsor and in compliance with the applicable
p.000012: regulatory requirement(s).
p.000012: 23. The sponsor should ensure laboratories used for generating data for clinical trials should be compliant with Good
p.000012: Laboratory Practices.
p.000012:
p.000012: Responsibilities of investigator(s)
p.000012: 24. Every clinical trial should be conducted under the charge and supervision of a principal
p.000012: investigator. All trial investigator(s), including the principal investigator(s) should possess appropriate
p.000012: qualifications, training, and experience and should have access to such investigational and treatment
p.000012: facilities as are relevant to the trial protocol.
p.000012: 25. The investigator is responsible for the conduct of the trial according to the protocol and GCP Guidelines. The
p.000012: investigator is responsible for giving adequate information to the study participant in respect of the
p.000012: clinical trial in accordance with the GCP Guidelines of the World Health Organization. The investigator should
p.000012: have adequate resources and facilities for the foreseen duration of the trial to conduct the trial to these
...
p.000012:
p.000012: no later than twenty four hours after he was first aware of the reaction. The sponsor should report any serious
p.000012: unexpected adverse drug reaction (as defined in the Good Clinical Practices (GCP) Guidelines of the World Health
p.000012: Organization) in CIOMS-I format as soon as possible, but no later than fifteen calendar days after the sponsor was
p.000012: first aware of such reaction to the SCOCT, the relevant Ethics Review Committee and the investigator(s)
p.000012: participating in the clinical trial. Any fatal or life-threatening serious unexpected adverse drug reaction should be
p.000012: reported by the sponsor to the SCOCT, the relevant Ethics Review Committee and the investigators
p.000012: participating in the clinical trial as soon as possible, but no later than seven calendar days after the
p.000012: sponsor was first aware of such reaction. All serious and unexpected adverse drug reactions related to the same
p.000012: investigational product reported from all sites involved with the same trial protocol driven clinical trial,
p.000012: should be reported with a causality statement by sponsor to the SCOCT and the relevant Ethics Review Committee that
p.000012: accorded approval to the trial protocol in the form of quarterly line listed reports.
p.000012:
p.000012: Test material particulars, identification and storage
p.000012: 46. The sponsor must ensure that the investigational product(s), including active comparator(s) and placebo
p.000012: if applicable, is manufactured in accordance with the principles and guidelines of Good Manufacturing Practice
p.000012: (GMP) for medicinal products of the WHO or similar accreditation body.
p.000012: 47. The sponsor must ensure that the product label on outer packaging of investigational medicinal
p.000012: product(s) or, where there is no outer packaging, on the immediate packaging, contains standard,
p.000012: internationally accepted information in English, which should include the following:
p.000012: (a) The reference number or other unique identification mark of each item of such material
p.000012:
p.000012: (b) A trial reference code allowing identification of the trial, site, investigator and sponsor if not given elsewhere
p.000012: (c) The date of manufacture and the expiry date of the test material
p.000012:
p.000012: (d) The storage conditions appropriate for each item of test material as may be indicated by the manufacturer, and
p.000012: (e) The words: "For Clinical Trial Use Only" or similar wording
p.000012:
p.000012: (f) Period of use (use-by date, expiry date or re-test date as applicable), in month/year format and in
p.000012: a manner that avoids any ambiguity
p.000012: 48. No test material should be used in a clinical trial if the container in which the test material is stored is not
p.000012: marked and labeled with the particulars specified in section 47.
p.000012: 49. If any code or cipher is used in the labeling of a test material, the key to the code or cipher should be made
p.000012: available to any doctor or dentist in an emergency and it should be made known to the SCOCT.
p.000012: 50. The Sponsor should ensure all investigational medicinal products are stored in such manner as to be easily
...
p.000012: internationally recognized and which must be observed for designing, conducting, recording and reporting clinical
p.000012: trials that involve the participation of human subjects. Compliance with GCP provides assurance that the
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 12 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: rights, safety, and well-being of trial subjects are protected, and the results of the clinical trials are credible;
p.000012: “Good Manufacturing Practice (GMP)” means that part of pharmaceutical quality assurance which ensures
p.000012: that products are consistently produced and controlled to the quality standards appropriate to their intended
p.000012: use and as required by the marketing authorization. In these guidelines, GMP refers to the current GMP
p.000012: Guidelines published by WHO.
p.000012: “Informed consent” means voluntary written assent of a study subject’s willingness to participate in a
p.000012: particular clinical trial and its documentation. Such consent shall be taken only after information about the clinical
p.000012: trial, including an explanation of its status as research, its objectives, potential benefits, risks and
p.000012: inconveniences, alternative treatment that may be available and the rights and responsibilities of the study subject
p.000012: has been provided to the potential study subject;
p.000012: “Investigational medicinal product” means any pharmaceutical product or placebo being tested or used as a
p.000012: reference in a clinical trial.
p.000012: “Investigational product labeling’ means labeling developed specifically for products involved in a clinical
p.000012: trial
p.000012: “Investigator" means a doctor or dentist, as the case may be, responsible for the conduct of the clinical trial and for
p.000012: the rights, health and welfare of the participants in the trial at a trial site. If a trial is conducted by a
p.000012: team of individuals at a trial site, the investigator is the responsible leader of the team and may be called
p.000012: the principal investigator;
p.000012: “Investigator’s Brochure” means A collection of data for the investigator consisting of all the relevant information
p.000012: on the investigational medicinal product(s), including chemical and pharmaceutical data and
p.000012: toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and
p.000012: the results of earlier clinical trials. There should be adequate data to justify the nature, scale and
p.000012: duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new
p.000012: data are generated, the investigator’s brochure must be updated.
p.000012: "Legal representative", in relation to a person who is to be used as a study subject in a clinical
p.000012: trial, means an individual or judicial or other body authorized under the law to grant consent on behalf of
p.000012: that person, to the participation of such person in the clinical trial;
p.000012: “Pharmaceutical product” means any substance or combination of substances which has a therapeutic, prophylactic or
p.000012: diagnostic use, or is intended to modify physiological functions, and is presented in a dosage form suitable for
p.000012: administration to humans.
p.000012: “Phase I clinical trials” mean the first trials of a new active ingredient or new formulations in man, often carried
p.000012: out in healthy volunteers. Their purpose is to establish a preliminary evaluation of safety, and a
p.000012: first outline of the pharmacokinetic and, where possible, a pharmacodynamic profile of the active ingredient in
p.000012: humans.
p.000012:
p.000012:
p.000012: Sub-Committee on Clinical Trials Cosmetics, Devices & Drugs Regulatory Authority
p.000012: Ministry of Health
p.000012: Page 13 of 15
p.000012:
p.000012: Guidelines for the conduct of clinical trials; Version 1.0, October 2014
p.000012:
p.000012:
p.000012: “Phase II clinical trials” mean the clinical trials performed in a limited number of subjects and are often, at a
p.000012: later stage, of a comparative (e.g. placebo-controlled) design. Their purpose is to demonstrate therapeutic
p.000012: activity and to assess short-term safety of the active ingredient in patients suffering from a disease or condition for
p.000012: which the active ingredient is intended. This phase also aims at the determination of appropriate dose
p.000012: ranges or regimens and (if possible) clarification of dose response relationships in order to provide an optimal
p.000012: background for the design of extensive therapeutic trials.
p.000012: “Phase III clinical trials” mean the clinical trials in larger (and possibly varied) patient groups with
p.000012: the purpose of determining the short and long-term safety/efficacy balance of formulation(s) of the active
p.000012: ingredient, and of assessing its overall and relative therapeutic value. The pattern and profile of any
p.000012: frequent adverse reactions must be investigated and special features of the product must be explored (e.g.
p.000012: clinically-relevant drug interactions, factors leading to differences in effect such as age).
p.000012: These trials should preferably be of a randomized double-blind design, but other designs may be acceptable, e.g.
p.000012: long-term safety studies. Generally, the conditions under which these trials are carried out should be as
p.000012: close as possible to normal conditions of use.
p.000012: “Phase IV clinical trials” Studies performed after marketing of the pharmaceutical product. Trials in phase IV are
p.000012: carried out on the basis of the product characteristics on which the marketing authorization was granted
p.000012: and are normally in the form of post-marketing surveillance, or assessment of therapeutic value or
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| dependence | Drug Dependence |
| disability | Mentally Disabled |
| drug | Drug Usage |
| embryo | embryo |
| emergency | Public Emergency |
| foetus | Fetus/Neonate |
| illness | Physically Disabled |
| incapacity | Incapacitated |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| parent | parents |
| placebo | participants in a control group |
| restricted | Incarcerated |
| single | Marital Status |
| substance | Drug Usage |
| threat | Threat of Stigma |
| unconscious | Unconscious People |
| volunteers | Healthy People |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| substance | ['drug', 'influence'] |
Trigger Words
coercion
consent
ethics
protect
protection
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input