ICH E6 good clinical practice guidelines

ICH E 6 good clinical practice (GCP)

1. GOOD CLINICAL PRACTICE 31-10-2023 1 Presented By : Mr. Rahul Raut F. Y. M. Pharm (Regulatory Affairs) RCPIOP

2. Introduction Sections Principles Ethics committee Responsibilities of sponsor, investigator, and monitor Investigator Brochure Essential Documents References 31-10-2023 2

3. What is GCP? 31-10-2023 3

4. 31-10-2023 4 Recording Documentation monitoring

5. Good Clinical Practices Good clinical practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the right, integrity, and confidentiality of trial subjects are protected. GCP ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented GCP Data & Result Ethics = + Right Safety Well-being Credible Accurate 31-10-2023 5

6. Objectives 31-10-2023 6

7. 8-Sections of ICH-GCP Guidelines 31-10-2023 7

8. 8-Sections of ICH-GCP Guidelines 31-10-2023 8

9. Glossary Adverse Drug Reaction (ADR) An adverse event (AE) Audit Audit Certificate Audit Report Case Report Form (CRF) Clinical Trial/Study Comparator (Product) Compliance (in relation to trials) 31-10-2023 9 Investigator's Brochure Monitoring Nonclinical Study Sponsor Standard Operating Procedures (SOPs) Monitoring Plan Good Clinical Practice (GCP) Compliance (in relation to trials) Confidentiality Contract Research Organization (CRO) Informed Consent Investigator

10. ICH GCP Principles 31-10-2023 10

11. 31-10-2023 11 Good clinical practice Should be conducted as per Ethical principles Mention as per Consisted with & 1

12. 31-10-2023 12 Before a trial is initiated foreseeable risks and inconveniences weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. 2

13. 31-10-2023 13 rights, safety, and well-being of the trial subjects Important should prevail over Interest of science & society 3

14. 31-10-2023 14 The available N onclinical & clinical information On an investigational product should be adequate to support 4

15. 31-10-2023 15 scientifically sound, and described in a clear, detailed protocol . CLINICAL TRIALS should be 5

16. 31-10-2023 16 should be conducted in compliance with the R eceived prior & Approval from 6

17. 31-10-2023 17 Medical Care Given to Trial subjects M edical decisions made on behalf of S hould always be the responsibility of a Q ualified physician or, qualified dentist. 7

18. 31-10-2023 18 Experience Each individual involved I n conducting a trial should be qualified by T o perform his or her respective task(s). 8

19. 31-10-2023 19 Trial subject Freely given informed consent S hould be obtained from every prior to C linical T rial P articipation. 9

20. 31-10-2023 20 Should be R ecorded H andled S tored I n a way that allows its 10

21. 31-10-2023 21 Trial subject Regulatory Requirements The confidentiality of record that could identify should be R especting the I n accordance with the applicable 11

22. 31-10-2023 22 Stored I n accordance with applicable Investigational Product Manufactured Handled S hould be Should be used in accordance with the approved protocol. 12

23. 31-10-2023 23 Systems with procedures that assure the quality of every aspect of the trial should be implemented. 13

24. 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 requirement(s). Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial. 31-10-2023 24 ICH GCP Principles

25. Clinical trials should be scientifically sound, and described in a clear, detailed protocol. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/ favourable opinion. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). 31-10-2023 25 ICH GCP Principles

26. Freely given informed consent should be obtained from every subject prior to clinical trial participation. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s) Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol. Systems with procedures that assure the quality of every aspect of the trial should be implemented. 31-10-2023 26 ICH GCP Principles

27. Ethics committee Responsibilities 31-10-2023 27 Or To protect the dignity, rights, and well-being of research participants. To ensure that universal ethical values and international scientific standards are followed. To Assist in the development and education of a research community responsive to local healthcare requirement. Review new and revised research protocol. Approved or disapproved of these protocols. Ensure that informed consent is documented if required. Conduct a continuing review of long-term research projects.

28. Composition of Ethics Committee Chairperson 1-2 basic medical scientists (preferably one pharmacologist) 1-2 clinicians from various institute One legal expert One social scientist/representative of a non-governmental voluntary agency One philosopher/ethicist One layperson from the community Member secretary 31-10-2023 28

29. Sponsor Responsibilities 31-10-2023 29

30. Investigator Responsibilities 31-10-2023 30 Investigator Qualification & agreements 1 Adequate Resources 2 Medical Care of Trial Subject 3 Communication With IRB/IEC 4 Compliance with Protocol 5 Investigational Product 6 Randomization Procedure 7 Final Report by Investigator 13 Premature Termination of a Trials 12 Safety Reporting 11 Progress Report 10 Records & Reports 9 Informed consent of a Trial subject 8

31. Clinical Trial Protocol Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards . 31-10-2023 31

32. Clinical Trial Protocol 31-10-2023 32

33. Investigators Brochure The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures 31-10-2023 33

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35. Essential Documents 31-10-2023 35 Investigator’s brochure Signed protocol and amendments, if any, and sample case report form (CRF) Information given to trial subject - informed consent form (including all applicable translations) Advertisement for subject recruitment (if used) Financial aspects of the trial Insurance statement Signed agreement between involved parties, e.g.: - Investigator/institution and sponsor, investigator/institution and CRO, sponsor and CRO, investigator/institution and authority(ies) (where required) Institutional review board/independent ethics committee composition Regulatory authority(ies) authorization/approval/ notification of protocol (where required) Curriculum vitae and/or other relevant documents evidencing qualifications of investigator(s) and sub-investigator(s) Certificate(s) of analysis of investigational product(s) shipped Master randomisation list Clinical study report

36. References https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3097692/ https://www.slideshare.net/abelmathew5/ichgcp-guidelines 31-10-2023 36

37. 31-10-2023 37 THANK YOU