Presentation is loading. Please wait.

Presentation is loading. Please wait.

Good Clinical Practice (GCP) in Clinical Research

Similar presentations


Presentation on theme: "Good Clinical Practice (GCP) in Clinical Research"— Presentation transcript:

1 Good Clinical Practice (GCP) in Clinical Research
Suchart Chongprasert, Ph.D. Food And Drug Administration ICH GCP for Clinical Research investigators, 16 December 2013, DMSC

2 Presentation Outline Practice vs. Research
clinical research vs. clinical trial therapeutic vs. non-therapeutic research GCP: Introduction and Principles Basic GCP Applications for Investigators Ethical Principles in Clinical Research Informed Consent Process: Introduction

3 Research vs. Practice “Practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client, and that have a reasonable expectation of success. standard interventions scientifically proven and accepted The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individual. BELMONT REPORT

4 Research vs. Practice (2)
“Research” designates an activity designed to test a hypothesis, permits conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge expressed for example in theories, principles, and statements or relationships) that can be corroborated by scientific observation and inference. BELMONT REPORT

5 Research vs. Practice (3)
Research is usually described in a formal protocol that sets forth an objective, and a set of procedures designed to reach the objective. BELMONT REPORT

6 Research vs. Practice (4)
Research represents a systematic investigation (formal), including research development, testing, evaluation, that is designed to develop or contribute generalizable knowledge. methodology Practice gains more flexibilities compared with research

7 GENERALIZABLE KNOWLEDGE [rationale and background]
RESEARH vs. PRACTICE GENERALIZABLE KNOWLEDGE Question Hypothesis Established Intervention Objectives RESEARCH PRACTICE Design Similar Conditions Trial Conclusion UNMET MEDICAL NEEDS [rationale and background]

8 Clinical Research research that either directly involves a particular person or group of people or uses materials derived from humans such as behaviors or samples of the tissues, that can be linked to a particular living person (identifiable tissue or bio-specimens)

9 Declaration of Helsinki 2013
ethical principles for medical research involving humans subjects, including research on identifiable human materials and data

10 Clinical Research [2]: categories
[1] Patient-oriented research: involves a particular person or group of people or uses of materials from humans studies of mechanisms of human disease; studies of therapies or interventions for diseases; clinical trials; and studies to develop new technology related to diseases

11 Clinical Research [3] ]: categories
[2] Epidemiological and behavior studies:.. examining the distribution of diseases, the factors that affect health, and how people make health-related decisions [3] Outcomes and health services research: seeking to identify the most effective and most efficient interventions, treatments, and services

12 Clinical Trials one type of clinical research that involves a researcher or researchers who directly observes a person or people, and/or who collect data to answer a scientific or medical question about the safety or potential benefit of an intervention such as medication, device, teaching concept, training method or behavioral change

13 Clinical Trials[2] a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) [US NIH]

14 Clinical Trials[3] a controlled study involving human subjects that is designed to prospectively evaluate the safety and effectiveness of new drugs or devices or of behavioral interventions [US DHHS, IRB Handbook] a systematic investigation, including research development, testing, and evaluation that is designed to develop or contribute to generalizable knowledge [US CFR Title 46 Part 102]

15 Clinical trial [4] any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are deemed synonymous. [ICH GCP]

16 Clinical Trial Clinical Research

17

18 Where generalizable knowledge comes from

19 Data Quality vs. Data Integrity

20 Data Quality vs. Integrity
Quality: a measure of the ability of a product, process, or service to satisfy stated or implied needs Data Quality: the essential characteristics of each piece of data, in particular, quality data should include: accurate; legible; complete and contemporaneous (recorded at the time activity occurs; original; attributable to the person who generated the data

21 Data Quality vs. Integrity
Data Integrity: the soundness of the body of the data as a whole, in particular, the body of data should be 1credible, 2internally consistent, and 3verifiable Both quality and integrity are essential for data to be relied upon for regulatory decision-making

22 Good Clinical Practice (GCP) in Clinical Research
Suchart Chongprasert, Ph.D. Food and Drug Administration ICH GCP for Investigators, 31 July 2013, Chaingmai

23 o [1] [2]

24 Special attentions paid on
Human subjects are protected Rights; Safety; Well being Clinical trial data are credible for regulatory decision; for scientific use to improve interventions

25 GCP significance ..randomized controlled clinical trials form the foundation for “evidence-based medicine”, but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as “Good Clinical Practice” (GCP)… Source: WHO Handbook for GCP: Guidance for Implementation

26 International Conference on Harmonization GCP

27 Clinical trial ...any investigation in human subjects intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are deemed synonymous. ICH GCP [1.12]

28 Clinical Trial the objective is to discover or verify
investigation/research in humans using pharmaceutical products investigational phase or approved one the objective is to discover or verify clinical / pharmacological / pharmacodynamic effects absorption/ distribution / metabolism / excretion so as to ascertain the safety and efficacy of investigational products

29 What is ICH GCP …. international ethical and scientific quality standard for the designing, conducting, recording, performing, monitoring, auditing, reporting a clinical trial that involves human participation... ICH GCP: Introduction

30 ICH GCP quality system being used in a clinical trial from the beginning to the end quality standard encompassing both [1] scientific, and [2] ethical aspects

31 Why GCP …. compliance with this guideline assures the public that the rights, safety, and well-being of trial subjects are protected, and that trial data are credible . ICH GCP : Introduction

32 Importance is given to Human subjects are protected Rights Safety,
Well being Clinical trial data are credible for regulatory decision for scientific use to improve interventions

33 ICH GCP - Objective …….to provide a unified standard for European Union, United States, and Japan to facilitate mutual acceptance clinical data by regulatory authorities in the three jurisdictions no repetition of quality clinical trials conducted previously in any of these regions ensuring the quality for the protection of humans as well as the quality and integrity of clinical data

34 ICH GCP - Development ...developed with the consideration of the current GCP of the EU, Japan, US as well as Australia, Canada, the Nordic Countries, and the WHO. combined together principles and guidelines implemented in advanced countries or organization promoting global acceptance of clinical data generated ICH GCP: Introduction

35 Applicability When to apply the ICH GCP?
….should follow when generating clinical data that are intended to be submitted to regulatory authorities in the three regions. support a regulatory decision for marketing authorization of pharmaceutical products ICH GCP: Introduction

36 other applicabilities
.. the principles established in this guideline can also be used for other clinical investigations that may affect safety and well-being of trial subjects. can be applied to broader than a clinical trial

37 considerations ..some principles of GCP may not apply to all types of research on human subjects; consideration of these principles is strongly encouraged wherever applicable as a means of ensuring the ethical, methodologically sound and accurate conduct of human subject’s research.. Source: WHO Handbook for GCP: Guidance for Implementation

38 Applications of GCP studies of a physiological, biochemical, or pathological process, or of a specific intervention controlled studies of diagnostic, preventive or therapeutic measures studies designed to determine the consequence for individuals and communities of specific preventive or therapeutic measures Source: WHO Handbook for GCP: Guidance for Implementation

39 Applications of GCP [2] studies concerning human health-related behavior in a variety of circumstances and environments studies that employ either observation or physical, chemical, or psychological intervention may generate records or make use of existing records containing biomedical or other information about individuals who may or may not be identifiable from the records or information

40 GCP Implementation: Shared Responsibilities

41

42

43 ICH GCP: STRUCTURE & CONTENT
Glossary Principles of ICH GCP IRB/IEC Investigator Sponsor Clinical Trial Protocol Investigator’s Brochure (IB) Essential Documents for the conduct of Clinical Trials Standard arrangement Personnel Documents

44 Fundamental Concepts of ICH G CP

45

46 ICH GCP Principles [1] ethical principles established in the Declaration of Helsinki (updated 2013) [2] favorable risk and benefits ratio at the beginning and continuing of a clinical trial [3] rights, safety, and well-being of trial subjects most important consideration, and precede the interests of science and society [4] nonclinical and clinical data (if any) available to support the proposed trial

47 ICH GCP Principles [2] [5] trial scientifically sound and written in a clear protocol [6] protocol receives prior approval from IEC/IRB [7] medial care and medical decision made be responsible by qualified physicians or dentists [8] investigator and staff qualified by education, training, and experience [9] freely informed consent obtained from individual subject prior to his/her participation

48 ICH GCP Principles [3] [10] clinical trial information be managed in a way that allows accurate reporting, interpretation, and verification [11] confidentiality of trial subjects [12] investigational product manufactured, handles, and stored according to GMP [13] QA system and procedures implemented throughout the trial

49 Advantages of GCP importance is given to (1) the protection of human subjects and (2) the quality and integrity of clinical data clear assignment of key individuals involving in a clinical trial i.e., investigator, EC, sponsor standardized glossary of terms standardized elements of informed consent standardized IRB/IEC membership emphasize on principles, de-emphasize on “how to”

50 Limitations of GCP very high standards to be applied in for the Thai context (in general); subject to easy deviation; require intensive resources to implement; sponsor QA may not be practical in a resource-poor setting; require adequate resources and investment in a regulatory authority

51 Ethics in Clinical Research and Independent Ethics Committee
Suchart Chongprasert, Ph.D. Food and Drug Administration ICH GCP for Investigators, 16 December 2013, DMSC

52 Presentation Outline Morality vs. Ethics
Basic Ethical Principles in Clinical Research RBJ Principles Practical Applications Independent Ethics Committee (IEC) / Institutional Review board (IRB)

53 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements ICH GCP Principle 1

54 Research involving humans should be scientifically sound and conducted in accordance with the basic ethical principles, which have their origin in the Declaration of Helsinki. Three basic ethical principles of equal importance, namely respect for person, beneficence, and justice permeate all GCP principles. WHO GCP Principle 1

55 summarized from Dr. Henry Beecher’s Article
“… the two more important things needed for ethical clinical research i.e., informed consent and virtuous investigators.” summarized from Dr. Henry Beecher’s Article

56 Basic Ethical Principles
Respect for person Autonomy (independence) Beneficence and [non-maleficence] maximizing benefit; minimizing harms; do no harm Justice distributive justice

57 Respect for Person Respect for person requires that subjects, to the degree that they are capable, be given opportunities to choose what shall or shall not happen to them. Belmont Report

58 Respect for Person People should be treated as an autonomous agent
subject autonomy Subjects with diminished autonomy need special protection vulnerable subjects

59 Respect for Person autonomous agent means individuals who are able to make their own decision regarding their goal and the process to achieve such goals focus paid on choice and opinion of each autonomous individual upon one’s determination right to self-determination

60 People with Diminished Autonomy
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case of refusal to participate

61 People with Diminished Autonomy (2)
Examples are members of a group with a hierarchical structure such as medical, pharmaceutical, and nursing students, subordinate hospital and laboratory personnel, employees of pharmaceutical industry, members of the arm forces, and persons kept in detention.

62 People with Diminished Autonomy (3)
Other vulnerable subjects include patients with incurable diseases, persons in nursing home, unemployed or impoverished persons, refugees, minors, and those incapable of giving own consent

63 special safeguard measures
additional safeguards to protect the rights, safety, and well-being of subjects with diminished autonomy special justification to the ethics committee that research could not be carried out equally well with less vulnerable subjects seeking permission of a legal guardian or other legally authorized representatives impartial witness monitoring the conduct of the study

64 Respect for Person right for self-determination; human’s dignity;
informed consent; vulnerable subjects; privacy and confidentiality

65 Beneficence moral obligation to maximize the benefits and to minimize harm requiring that risks of research be reasonable in the light of the expected benefits research design be sound instigators be competent both to conduct the research and to safeguard the welfare of the subjects

66 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefits for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks ICH GCP 2.2

67 Clinical trials should be scientifically sound and described in clear detailed protocol
ICH GCP 2.5

68 The medical care given to, and medical decision made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a dentist ICH GCP 2.7

69 Beneficence in addition to maximizing benefits and minimizing risks or harm beneficence sometimes expressed as a separate principle of non-maleficence (do no harm)

70 “Risks and benefits of research may affect the individual subjects… and society at large (or special groups of subjects in society).” “In balancing these different elements, the risks and benefits affecting the immediate research subjects will normally carry special weight.” Belmont Report

71 The rights, safety, and well-being of the trial subjects are the most important considerations, and should prevail over the interests of science and society. ICH GCP 2.3

72 Justice “distributive” justice
who bears the burden/risk of research who takes benefits giving rise to moral requirements that there be fair procedures and outcomes in the selection of trial subjects

73 Justice [2] justice in the selection of research subjects requires attention in two respects individual social equity requires that no group or class of persons should bear more than its fair share of the burdens of participation in research

74 Justice [3] Subject should be drawn from qualifying population in the general geographic area of the trial without regard to race, ethnicity, economic status, or gender unless there is a sound scientific reason to do otherwise CIOMS Guideline 12

75 Practical Applications
Informed consent [Respect for Person] informed decision making Risk/benefit assessment [Beneficence] favorable ratio Selection of trial subjects [Justice] fair and equitable procedures and outcomes

76 Suitability of Informed Consent
sufficiency of information given; basic minimum elements understanding; understood consent voluntariness; freely given without undue influence

77 Remember! The three ethical principles are originally derived from the Western culture In applying these principles, please take into account local norms, cultures, and traditions as appropriate Consult IEC, if needed

78 Ethics Committee

79 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB) /independent ethics committee (IEC) approval or/favorable opinion. ICH GCP Principle 2.5

80 A trial should be conducted in compliance with the protocol that has received prior IRB/IEC approval/favorable opinion. ICH GCP Principle [2.6]

81 Institutional Review Board
An independent body constituted of medical, scientific, and non-scientific members whose responsibility is to ensure the protection of rights [1], safety [2], and well-being [3] of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendment (s) and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects ICH GCP [1.31]

82 Independent Ethics Committee
An independent body (a review board or a committee, institutional, regional, national or supranational) constituted of medical professionals and non-medical members whose responsibility is to ensure the protection of the rights [1], safety [2], and well-being [3] of human subjects involved in a trial, and to provide public assurance of that protection by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining informed consent of the trial subjects ICH GCP [1.27]

83 IRB/IEC Institutional Review Board (IRB) used in the US
Independent Ethics Committee (IEC) used in Europe deem synonymous in Thailand, both are used interchangeably ERC, REC

84 IRB/IEC independent board / committee (free of any undue influence to perform their task and make the decision) exist in several levels depending on situations e.g., institutional (CU, MU) , national (MOPH), regional (EU), or supranational members with medical and non-medical professions responsible for protection of human subjects in a trial (rights, safety, and well being)

85 IRB/IEC assuring the public of their achieved responsibilities by performing the following tasks reviewing and approving the trial protocol; suitability of the investigator and the team (through most update CVs); adequate facilities to conduct the trial; methods and materials to be used in obtaining informed consent etc.

86 IRB/IEC interface between the investigator and the subjects
possessing a formal authority for the approval of the trial and/or suspending/terminating the trial based upon the applicable laws and regulations

87 Declaration of Helsinki !!
Why IEC Review? required independent review of a research protocol one of the criteria for determining if the conduct of a clinical trial is ethical protection of subjects ensure safety and well being of subjects Declaration of Helsinki !!

88 Policy IRB/IEC constituting and operating in accordance with the ICH GCP written approval received prior to initiating the trial if no constituted / appropriate IEC, use an independent IEC such as MOPH IEC

89 IEC Composition consist of a reasonable number of members, who collectively have the qualifications and experiences to review and evaluate the science[1], medical[2] aspects, and ethics[3] of the proposed trial If it is not scientifically valid, it is unethical

90 Preparation and Submission
investigator needs to obtain confirmation of IEC members present and occupation inform IEC of any payments to subjects and advertisements, if any obtain a list of IEC members

91 Documents for Submission
Informed Consent/Patient Information Sheet protocol and amendments Investigator’s Brochure/drug information EC submission Diary cards payment schedule any advertisements

92

93 Roles of Investigator interface between sponsor and ethics committee
satisfies documentation requirements updates ethics committee as required safety progress; safety, SAEs; progress report, etc.

94 Roles of Investigator [2]
Investigator must not be involved in the approval process not influence / apply pressure to committee members communicate with the IEC in an appropriate manner (e.g., respect for their decision, appeal the decision with supportive new scientific evidence for the protocol etc.)

95 IRB/EC Decision unconditional approval documented in writing
be signed and dated by Chairman / Secretariat approval letter bears full the protocol number and title and/or version Note: a trial must not be begun prior to receiving the IEC approval letter !!

96 Summary independent review is mandatory in biomedical research, including a clinical trial competent IRB/IEC fulfills the requirement of the Declaration of Helsinki, ICH GCP, and applicable regulations investigator should ensure that the trial protocol is reviewed and approved by a competent ethics committee

97 Summary [2] investigator should obtain an EC approval letter before commencing the trial investigator should ensure a regular contact with the EC in case of new information, amendments, progress report, or safety update etc.

98 Informed Consent Process
Suchart Chongprasert, Ph.D. Food and Drug Administration ICH GCP for Clinical Research investigators, 31July 2013, Chiangmai

99 Presentation Outline What does it means?
Basic Elements of Informed Consent Certain Important Aspect of Informed Consent Exercise

100 Freely given informed consent should be obtained from every subject prior to clinical trial participation ICH GCP Principle [2.9]

101 Declaration of Helsinki
“… each potential subject must be adequately informed of the aims, methods, anticipated benefits and potentials hazards of the study and the discomforts it may entail.” “…the physician should obtain the subject’s freely given informed consent, preferably in writing.” Declaration of Helsinki

102 A process1 by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form. ICH 1.28

103 ..an ongoing process, not a form for just signing
Informed consent ..an ongoing process, not a form for just signing A process by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form.

104 no coerce or use undue influence
Informed consent A process1 by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form. no coerce or use undue influence

105 ….two way communication and answer to subject’s satisfaction
Informed consent ….two way communication and answer to subject’s satisfaction A process1 by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form.

106 thoroughly about the trial e.g., purpose, benefits, payment etc.
Informed consent A process1 by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form. thoroughly about the trial e.g., purpose, benefits, payment etc.

107 subject’s autonomy to make their own judgment
Informed consent A process1 by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form. subject’s autonomy to make their own judgment

108 ….acceptable way under the ICH GCP context
Informed consent A process1 by which a subject voluntarily2 confirms his or her willingness to participate in a particular trial, after having been informed3 of all aspects4 of the trial that are relevant to the subject’s decision5 to participate. Informed consent is documented by means of a written6 signed7 and dated8 informed consent form. ….acceptable way under the ICH GCP context

109

110 Informed consent Desirable informed consent
adequate information disclosed language suitable to the recipient not too technical avoid a non-mother language remember that the readers are not scientific expert/ethics committee members

111 Methods for Documenting Informed Consent
written informed consent In accordance with ICH GCP oral witnessed consents no documented evidence beyond the scope of ICH GCP

112 Elements of IC (ICH GCP)
1. involve research; 2. research purpose; 3. choice of treatments, including randomization; 4. trial procedures, including invasive ones; 5. subject’s responsibilities; 6. trial aspects that are experimental; 7. foreseeable risks/inconvenience

113 Elements of IC [2] 8. anticipated benefits, if not any, inform as well; 9. treatment alternative if not willing to participate and related risks/benefit; 10. compensation/treatment in case of trial-related injury; 11. prorated payment, if any; 12. expected expenses, if any, for participating;

114 Elements of IC [3] 13. voluntary statement;
14. statement for direct access by monitor, auditor, IEC/IRB, authority upon signing the consent form; 15. confidentiality of the subject’s private info. kept; 16. be informed timely available new information affecting the willingness to continue in the trial;

115 Elements of IC [4] 17. contact person for more information or in case of injury; 18. circumstances for withdrawal/ termination; 19. expected duration; 20. approximate number of trial subjects (local vs. global)

116 Important Considerations
consent must be informed; careful about the uninformed informed consent ensure subjects’ understanding (understood consent) subjects given ample time; all questions answered to the subject's satisfaction; no undue pressure/influence; language clearly understood by the subjects recommended not higher than grade 8

117 Important Considerations [2]
no language causing the subjects or the legally acceptable representatives to waive their legal rights; IC not a legal contract / agreement ICF personally signed and dated by the subject and the person obtaining the ICF; a copy of ICF given to subject prior to participation;

118 Suitability Considerations for IC
informed and [ understood ] consent; respect for subject’s right to self-determination (autonomy) disclose sufficient information; all aspects about the trial suitable for subject’s capacity (normal vs. diminished); age; educational status; sex; culture, geosocial factors etc.

119 Suitability Considerations for IC [2]
voluntariness; and practicality amount of the given info. vs. time for consideration in reality short form?? depending on investigator’s explanation

120 Importantly! In principle, obtaining informed consent in a clinical research is a must Waiving of informed consent is an exception which should be well-justified and received prior approval from IEC/IRB before implementation

121 IC Exercise

122 Practical Considerations
Q: Who should obtain informed consent ? A: In general, the investigator or authorized person obtains the informed consent. According to the Helsinki Declaration, the physician who treats the potential subject should not obtain the consent by him/herself, instead other physician who understands the protocol well does. Avoid doctor/patient dependent relationship.

123 Practical Considerations
Q: Obtaining informed consent in children / minor ? A: For children with legal incompetence (i.e., age <20 yrs), but able to give assent to the research protocol, an assent form should be obtained besides parent’s informed consent [assent: affirmative agreement to participate in the trial]

124 Practical Considerations
Q: When to conduct the trial in relation to the time to obtain the informed consent ? A: The study cannot start prior to receiving a written informed consent from the subjects. Also, an unconditional written ethics committee’s approval letter must be obtained before beginning the trial.

125 Practical Considerations
Q: Informed consent in a clinical pharmacology trials (PK, phase I study)? (i.e., non therapeutic trial) A: Should be conducted in the subjects who can give informed consent by themselves by personally signing and dating on the form.

126 Practical Considerations
Q: When should the informed consent be amended ? A: When new information that may affect the safety and well being of the subject becomes available, and it may affect the subject’s decision to continue participating in the trial.

127 Practical Considerations
Q: How long should it take to obtain the informed consent? A: Depending on the situation. Remember that informed consent is an ongoing process, not finished upon the signature of the subject. Specifically, how long it takes until the subject signs and date on the form is what the investigator needs to know. Exact time cannot be established, but the investigator needs to achieve efficient project management and obligation under the GCP on obtaining informed consent.

128 Summary Informed consent is a continuing process to confirm subject's voluntary willingness to participate in the trial. Informed consent should be obtained from each patient prior to enrolling the subject into the trial. Children’s assent form is required in most clinical trials involving children (below majority age) participation

129 Thank you for your attention


Download ppt "Good Clinical Practice (GCP) in Clinical Research"

Similar presentations


Ads by Google