GCP, IC New.pptx for good clinic practices

Good Clinical Practices

1. GOOD CLINICAL PRACTICE (GCP) Dr. George Dilu Thomas Assistant Professor Department of Pharmacology

2. LEARNING OBJECTIVES

3. GOOD CLINICAL PRACTICE It is an international ‘ Ethical’ and ‘ Scientific’ Quality standard for d e si g ning, c o n d u cti n g , mo n itorin g , recording and rep o rt i ng tr i als that in v ol v e the participation of human subjects.

4. GCP-PURPOSE

5. GCP-HISTORICAL BACKGROUND Sulphanilamide disaster (1937)

6. Nuremberg code (1947) : Ethical principles for conducting clinical trials

7. Thalidomide D isaster 1962

8. De c lara t ion of He l sinki 1964 : Gave the ba s i c structure for the ethical principles of GCP. B e l m o n t rep o rt 1979 : Ide n ti f ies b a s i c ethi c a l prin c i p les & g u idelines a d dre s sing ethical issues arising in clinical trials. IC H- G CP :Principles ba s ed on the Internatio n al c o n f ere n ce on h a r m o n iz a tion of tec h n i c a l req u i r em e n t s for registration of pharmaceuticals for human use.

9. Principles of GCP Ethical conduct of trials Trial Benefits should be more than risks Preference for Subjects over science & society Adequacy of pre-existing information Scientific validity of trials Independent review before trial begins Medically qualified care Trained personnel Informed consent Efficient information handling Confidentiality Accountability of investigational drug Quality systems

10. PRINCIPLES OF ICH GCP Ethical conduct : Clinical trials to be conducted in accordance with ethical principles that have their origin in Declaration of Helsinki. Risk benefit assessment : A trial should be initiated continued ONLY if anticipated benefits justify the risks. Trial subjects over science & society : The rights, safety & well being of the individual trial subject should prevail over interests of science & society. Adequacy of pre-existing information : The available information(from preclinical studies) on investigational product should be adequate to support the clinical trial

11. Scientific validity : Clinical trials should be scientifically sound & described in clear, detailed protocol. Independent review : The protocol of trial should receive prior approval from IRB / IE before trial is started. Medical qualified care : The medical care given to the trial subjects should be the responsibility of a qualified medical professional. Trained & experienced personnel : Each individual involved in the conduct of trial should be qualified for their respective tasks.

12. Informed consent : Freely given IC to be obtained from each trial subject. Efficiency of information handling : CT information should be recorded, handled, stored correctly. Confidentiality : Confidentiality of records that could identify subjects should be protected. Drug accountability : Investigational drugs used in trial should be manufactured, handled and stored in accordance with GMP Quality system & procedures : System that ensure quality of every aspect of clinical trial should be implemented.

13. ROLES OF ​ ETHICS COMMITTEE ​ INVESTIGATOR ​ SPONSOR

14. Let us look at the clinical trial p r ocess Sponsor gets IND license from regulatory agency Ap p r o v al by IEC Site & investigator s e l ect i on

15. KEY PLAYERS IN A CLINICAL TRIAL In s tituti on al Ethics Committee Pharma c omp a n y

16. ROLE OF SPONSOR To implement quality assurance systems to ensure trial is done as per GCP guidelines. To design trial using qualified individuals. To allocate duties for the trial. To finance the trial. To ensure complete information on efficacy & safety of the investigational drug is present before trial is initiated.

17. ROLE OF SPONSOR To manufacture, package, supply the Investigational drug to trial sites. To monitor & audit ongoing trial so that rights of participants are protected & data is accurate. To handle & record trial data. To report ADR to the regulatory authorities & IEC. To provide Compensation to subjects in case of claims appearing from the trial.

18. ROLE OF ETHICS COMMITTEE To safeguard the rights, safety & well being of all trial subjects. To obtain documents : e.g. Trial protocol, written informed consent form, investigators brochure, available safety information, information about payments and compensation available etc . To review the protoco l within reasonable time & give its review.

19. ROLE OF ETHICS COMMITTEE To ensure that protocol addresses relevant ethical concerns. To continue periodic review of ongoing trials. To review both the amount and method of payment of compensation to the subjects.

20. ROLE OF INVESTIGATOR To conduct trial according to the protocol & GCP guidelines. To document standard operating procedures. To provide information of trial to the subject through informed consent process . To ensure adequate medical care to the participant for any adverse effect during or after the trial

21. To report serious adverse events to the central licensing authority, the sponsor and the ethics committee within 24 hours of its occurrence. To inform the institution, and provide complete report to the sponsor , summary of trials outcome to ethics committee and the regulatory authority on c ompletion of trial. ROLE OF INVESTIGATOR

22. Informed Consent Form & Informed Consent Process

23. Informed Consent Form Written document of informed consent taken voluntary from every subject before any study related procedure and documented on Ethics committee approved format, adhering to GCP, based on Helsinki Declaration

24. Informed Consent Process The process by which a patient learns about and understands the purpose, benefits & potential risks of a medical or surgical intervention, including clinical trials & then agrees to receive treatment or participate in the trial.

25. Need of informed consent form

26. Elements of consent form

27. Elements of informed sheet - Essential elements Title of project Name of Principal Investigator Name of Organization Name of Sponsor Name of Proposal and version

28. Elements of informed sheet - Essential elements A statement that the study involves research , an explanation of purposes of research and the expected duration of the subject's participation , a description of the procedures to be followed, and identification of any procedures which are experimental. Description of any reasonably foreseeable risks or discomforts to subject. A description of any benefits to the subject or to others which may reasonably be expected from the research. A disclosure of appropriate alternative procedures or courses of treatment, if any , that might be advantageous to the subject.

29. A description of the extent to which confidentiality of records will be maintained For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained. An explanation of whom to contact for answers to questions about research and research subjects' rights , & in event of a research-related injury to subject. A statement that participation is voluntary , that refusal to participate will involve no penalty or loss of benefits to which subject is otherwise entitled & subject may discontinue at any time without penalty or loss of benefits to which subject is otherwise entitled. Elements of informed sheet - Essential elements

30. Elements of informed sheet -Additional Elements

31. Certificate of Consent

32. Certificate of Consent

33. Informed consent process

34. Informed Consent Process The process by which a patient learns about and understands the purpose, benefits, and potential risks of a medical or surgical intervention, including clinical trials, and then agrees to receive the treatment or participate in the trial. 35

35. Informed Consent: Parties Responsible Informed Consent & Subject Sponsor EC / IRB Investigator

36. Responsible authorities & Responsibilities

37. Process of information given to subject Informed consent process is not the process of taking signature but its exchange of information to the subject. Inform and Explain the subject every details of the research project as mentioned in consent form Respond to every doubt of subject related to research project and his participation If subject after giving detailed information agrees voluntarily to participate in study then take the signature.

38. Informed Consent: Non-English speaking / Illiterate subject Summary and consent in the vernacular language Written translation of ICF Thumb impressions allowed Document method of obtaining consent Impartial Witness/Video tape

39. Informed Consent: Children

40. Parent / Guardian Signatures for Minor Assent Research that does not involve more than minimal risk . Requires one parent’s signature. Research involving more than minimal risk but presents the prospect of direct benefit to the individual participants . Requires one parent’s signature . Research involving more than minimal risk and no prospect of direct benefit to individual participants , but likely to yield generalizable knowledge about the participant's disorder or condition. Requires both parents’ signatures , unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care & custody of the child.

41. Documentation component of IC Documentation Is in writing Bears the signature of the subject / subjects legally authorized representative Should also be signed by the investigator-to witness the subject’s signature & to affirm sufficient information has been given. Date of signing should affix all signatures. 3 copies-1 for patient, 1 for investigator, 1 to be kept with hospital notes

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