ICH-GCP Guidelines

An overview of ICH-GCP guidelines of clinical trials.
Good clinical practice (GCP): 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

1. Overview of ICH-GCP Guidelines Abel C. Mathew P harm D S tudent Al Shifa College of pharmacy 1

2. CONTENTS Introduction Historical Background Sections Principles Ethics committee Responsibilities of sponsor, Investigator and monitor Investigators Brochure Informed consent process 2 Overview of ICH-GCP guidelines

3. Good clinical practice (GCP): 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. GOOD CLINICAL PRACTICES 3 Overview of ICH-GCP guidelines

4. Overview of ICH-GCP guidelines 4 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 ICH-GCP is an International Conference on Harmonization Good Clinical Practice.

5. OBJECTIVES Overview of ICH-GCP guidelines 5 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.

6. HISTORICAL BACKGROUND 6 Overview of ICH-GCP guidelines

7. 7 NUREMBERG CODE(1946) German Physicians conducted medical experiments on prisoners of war without their consent . Most of the participants of these experiments died or were permanently crippled. • In December 9, 1946 - American military tribunal opened criminal proceedings against 23 leading German physicians • The Nuremberg Code was established in 1948, stating that "The voluntary consent of the human participant is absolutely essential," Nuremberg Code was the first international document which advocated voluntary participation and informed consent. Overview of ICH-GCP guidelines

8. 8 KEFAUVER AMENDMENTS(1960) • 6000-12000 children had congenital anomalies d/t maternal use of Thalidomide . • 1962 US Senate hearings Kefauver Amendments passed into law - For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them Overview of ICH-GCP guidelines

9. 9 DECLARATION OF HELSINKI • Adopted by the 18th WMA general assembly Helsinki, Finland, June 1964. It has since undergone seven revisions (the most recent at the general assembly in October 2013) . • A statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. • The Declaration specifically addressed clinical research, reflecting changes in medical practice from the term 'Human Experimentation' used in the Nuremberg Code Overview of ICH-GCP guidelines

10. 10 TUSKEGEE SYPHILIS STUDY- 1932 TO 1972 The US Public Health Services conducted a Syphilis Study on 600 low income African-American individuals • Stopped in 1972 • L ed to the 1979 Belmont Report and the establishment of OHRP. Overview of ICH-GCP guidelines

11. Overview of ICH-GCP guidelines 11 1982 INTERNATIONAL GUIDELINES FOR BIOMEDICAL RESEARCH INVOLVING HUMAN SUBJECTS. 1996 ICH-GCP GUIDELINES ISSUED. 1997 ICH-GCP GUIDELINES BECOME LAW IN SOME COUNTRIES.

12. 8-SECTIONS OF ICH- GCP GUIDELINES Overview of ICH-GCP guidelines 12

13. Overview of ICH-GCP guidelines 13

14. 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. GCP PRINCIPLES 14 Overview of ICH-GCP guidelines

15. 5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol. 6. 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. 7. 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. 8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s). 9. Freely given informed consent should be obtained from every subject prior to clinical trial participation. 15 Overview of ICH-GCP guidelines

16. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. 11.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). 12.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. 13.Systems with procedures that assure the quality of every aspect of the trial should be implemented. 16 Overview of ICH-GCP guidelines

17. ETHICS COMMITTEE RESPONSIBILITIES 17 1 . To protect the dignity, rights and well being of research participants. 2 . To ensure that universal ethical values and international scientific standards are followed. 3 . 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. Overview of ICH-GCP guidelines

18. 18 COMPOSITION 1 . Chairperson 2 . 1-2 basic medical scientists (preferably one pharmacologists). 3 . 1-2 clinicians from various Institutes 4 . One legal expert or retired judge 5 . One social scientist / representative of non-governmental voluntary agency 6 . One philosopher / ethicist 7 . One lay person from the community 8 . Member Secretary Overview of ICH-GCP guidelines

19. SPONSOR RESPONSIBILITIES Overview of ICH-GCP guidelines 19

20. INVESTIGATOR RESPONSIBILITIES Overview of ICH-GCP guidelines 20

21. CLINICAL TRIAL PROTOCOL Overview of ICH-GCP guidelines 21

22. INVESTIGATORS BROCHURE Overview of ICH-GCP guidelines 22 The Investigator’s Brochure 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. 

23. The PI discusses the trial’s risks, benefits and other aspects with the potential participant and, if required, the participant’s legal representative, before the trial begins . The PI gives the potential participant ample time and opportunity to ask questions about the trial and discuss it with relatives and family members . If the potential participant decides to get involved in the trial, he or she provides voluntary consent by signing and dating the written informed consent document of which he or she also receives a copy. The participant has the right to withdraw consent at any time without penalty, repercussions or reason. Overview of ICH-GCP guidelines 23 INFORMED CONSENT PROCESS

24. Thank You For your attention 24 Any questions??? Overview of ICH-GCP guidelines