Good Clinical Practice Guidelines ppt.pptx

Good clinical practice ICH GCP E6

1. Good Clinical Practice Guidelines ICH GCP E6 DATE OF PRESENTATION : 30-04-2024 ROSFEENA JOSEPH 1ST SEMESTER MPHARM REGULATORY AFFAIRS CHEMISTS COLLEGE OF PHARMACEUTICAL SCIENCES AND RESEARCH

2. OUTLINE Introduction Objectives Sections Principles Ethics committee Responsibilities of Sponsor, Investigator and Monitor Clinical Trial Protocol Investigators Brochure Informed Consent process Essential documents Conclusion

3. INTRODUCTION Good clinical practice (GCP) It is a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected. ICH-GCP is an International Conference on Harmonization Good Clinical Practice. The guideline was developed with consideration of the current good clinical practices of the European union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the world health organization

4. OBJECTIVES To protect the rights of human subjects participating in clinical trials To ensure the scientific validity and credibility of the data collected in human clinical studies. More economical use of human, animal and material resources. To provide an unified standard for the European Union, Japan and the United States to facilitate the mutual acceptance of the clinical data by the regulatory authorities in these jurisdictions .

5. ICH GCP E6 The 1 st guideline for good clinical practice (ICH E6 R1) was published in 1996. The guidelines are very detailed and categorized in several sections. There are 13 core principles for ICH GCP. It ensures the safety, rights and wellbeing. Integrated addendum to ICH E6(R1):guideline for good clinical practice E6(R2) was published on 2016. ICH Harmonized guideline good clinical practice (GCP) E6(R3) was published on may 2023. R3 is the latest revision of ICH E6.

6. 8 Sections of ICH-GCP Guidelines ------------------------------------------------------------------------------------------------

7. 13 PRINCIPLES OF GCP 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.

8. 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/favorable 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). Freely given informed consent should be obtained from every subject prior to clinical trial participation.

9. 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.

10. ETHICS COMMITTEE RESPONSIBILITIES _____________________________________________________________ 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 the education of a research community responsive to local health care requirements The researcher should submit an appropriate application to the IEC along with the study protocol. The IEC should be able to provide complete and adequate review of the research proposals submitted to them. All documentation and communication of an IEC are to be dated, filed and preserved according to written procedures. Strict confidentiality is to be maintained .

11. COMPOSITION Chairperson 1-2 basic medical scientists (preferably one pharmacologists). 1-2 clinicians from various Institutes One legal expert or retired judge One social scientist / representative of non-governmental voluntary agency One philosopher / ethicist One lay person from the community Member Secretary

12. SPONSOR A sponsor in literal terms is defined as an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study . In case an investigator independently initiates and takes full responsibility for a trial, he/she automatically assumes the role of a sponsor .

13. SPONSOR RESPONSIBILITIES _____________________________________________________________ • Quality Management • Critical Process and Data Identification • Risk Evaluation, Identification, and Control • Risk Communication, Review and Reporting • Quality Assurance and Quality Control • Contract Research Organization (CRO) • Medical Expertise • Trial Design • Trial Management, Data Handling, and Record Keeping • Investigator Selection • Allocation of Responsibilities • Compensation to Subjects and Investigators

14. • Financing • Notification/Submission to Regulatory Authority • Confirmation of Review by IRB/IEC • Information on Investigational Product • Manufacturing, Packaging, Labelling, and Coding Investigational Product • Supplying and Handling Investigational Product • Record Access • Safety Information • Adverse Drug Reaction Reporting • Monitoring • Audit • Noncompliance • Premature Termination or Suspension of a Trial • Clinical Trial/Study Reports

15. INVESTIGATOR Investigator: A person responsible for the conduct of the study at the trial site. Investigator is a person responsible for the rights, health and welfare of the study subjects. Principal investigator: In case the study is conducted by a team of investigators at one site or at multiple sites, then the investigator who coordinates between the different investigators involved in the study is termed as the Principal investigator.

16. Investigator responsibilities ______________________________________________________________ Familiar with investigational products Comply with GCP & regulatory requirements Medical care of the trial subjects Communication with IRB/IEC Compliance with protocol Investigational product

17. Investigator's Qualifications and Agreements The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement, and should provide evidence of such qualifications through up-to-date curriculum vitae and other relevant documentation requested by the sponsor, the IRB/IEC, and the regulatory authority. The investigator should be thoroughly familiar with the appropriate use of the investigational product, as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

18. CLINICAL TRIAL PROTOCOL The protocol is a document that describes how a clinical trial will be conducted (the objectives, design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected. A protocol is the precise and detailed design for conducting a research study; specifically, it is the study plan submitted to an IRB for review.

19. AIMS OF PROTOCOL 1. To raise the question to be researched and clarify its importance. 2. To collect existing knowledge and discuss the efforts of other researchers who have worked on the related questions (Literature review). 3. To formulate a hypothesis and objectives. 4. To clarify ethical considerations. 5. To suggest the methodology required for solving the question and achieving the objectives. 6. To discuss the requirements and limitations in achieving the objectives.

20. KEY BENEFITS

21. Main contents

22. INVESTIGATORS BROCHURE An Investigator’s Brochure is a collection of clinical and non-clinical data about the investigational products that are the focus of the study. The brochure should provide an ongoing insight into the clinical trial study participants during the duration of the trial. The purpose of an Investigator’s Brochure is to provide Investigators and other crucial people involved in the trial with enough information to help their understanding of the reasons for and compliance with the key features of a clinical trial protocol including dose, dose frequency, methods of administration and safety monitoring procedures. .

23. INFORMED CONSENT ______________________________________________________________ A process in which patients are given important information, including possible risks and benefits, about a medical procedure or treatment, genetic testing, or a clinical trial. This is to help them decide if they want to be treated, tested, or take part in the trial. Informed consent is crucial in research as it ensures individuals have an informed choice about whether to participate in a research study.

24. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated:

25. Before the clinical phase of the trial commences • INVESTIGATOR'S BROCHURE • SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF) • INFORMATION GIVEN TO TRIAL SUBJECT-INFORMED CONSENT FORM • FINANCIAL ASPECTS OF THE TRIAL • INSURANCE STATEMENT (where required) • SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.:- investigator/institution and sponsor • DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) • INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE COMPOSITION

26. Documents generated during the clinical conduct of the trial • INVESTIGATOR'S BROCHURE UPDATES • ANY REVISION TO: protocol/amendment and CRF informed consent form - any other written information provided to subjects - advertisement for subject recruitment • DATED, DOCUMENTED APPROVAL / FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB)/INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: Protocol amendment Revision of: Informed consent form Any other written information to be provided to the subject advertisement for subject recruitment Any other documents given approval/favorable opinion Continuing review of trial • REGULATORY AUTHORITY AUTHORISATIONS / APPROVALS / NOTIFICATIONS • CURRICULUM VITAE FOR NEW INVESTIGATOR AND/OR SUB-INVESTIGATOR

27. Documents generated after termination of clinical trial • Investigational product accountability at site • Documentation of investigational product destruction • Completed subject identification code list • Audit certificate • Final trial close-out monitoring report • Treatment allocation and decoding documentation • Final report by investigator to irb / iec where required, and where applicable, to the regulatory authority • Clinical study report

28. CONCLUSION Good Clinical Practice (GCP) is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants. ICH GCP E6 is a comprehensive document, and it's essential for all parties involved in clinical trials, including investigators, sponsors, and regulatory authorities, to be familiar with its principles and guidelines. Adherence to ICH GCP E6 helps ensure the integrity, reliability, and ethical conduct of clinical trials, ultimately contributing to the safety and well-being of study participants and the validity of trial results. 29

29. REFERENCES https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-guideline-good-clinical-practice_en.pdf https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1 https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf 30

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