GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3)

About Course

The final version of ICH E6 (R3) (.PDF) Good Clinical Practice (GCP) Guidelines was published on 6th January, 25 and recommended for adoption by regulatory bodies.

Good Clinical Practice (GCP) is an international, ethical, scientific, and quality standard for the conduct of trials involving human participants. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected; that the conduct is consistent with the principles that have their origin in the Declaration of Helsinki; and that the clinical trial results are reliable.

The ICH GCP Guideline was developed with input from various regions. The initial version was finalised in 1996 and outlined responsibilities for trial participants. Revised in 2016 and again in January 2025, the guidelines now incorporate modernised approaches, including digital tools and decentralised models, while maintaining human subject protection. These guidelines should be followed for clinical trial data submitted to regulatory authorities and can apply to other clinical investigations affecting human safety.

Course Content

Introduction to ICH GCP E6 (R3) Good Clinical practice
The module introduces ICH GCP E6 (R3) Good Clinical Practice. It begins with an overview of the changes from R2 to R3.

Module I. Introduction to R3 Good Clinical Practice

17:00
Module II: The ICH E6(R3) principles,

28:00

Module 1: Institutional Review Boards/ Independent Ethics Commitee
The session begins with an introduction to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC). It covers various aspects, including submission and communication procedures, responsibilities, composition, functions, operations, procedures, and records.

Module 2. Investigators
The section outlines the investigator responsibilities from 2.1 to 2.13.

Module 3. Sponsor

Module 4. Data Governance

Module 5. APPENDICES
This section outlines the three appendices as per R3, the Investigator’s Brochure (Appendix A), the Clinical trial protocol (Appendix B), and any applicable protocol amendments (Appendix C). Additionally, it includes session records (Appendix C).

About Course

Course Content

Introduction to ICH GCP E6 (R3) Good Clinical practice
The module introduces ICH GCP E6 (R3) Good Clinical Practice. It begins with an overview of the changes from R2 to R3.

Module I. Introduction to R3 Good Clinical Practice

Module II: The ICH E6(R3) principles,

Module 1: Institutional Review Board/ Independent Ethics Committee

Module 2. Investigators
The section outlines the investigator responsibilities from 2.1 to 2.13.

Module 2.1-2.7 Investigators responsibilities

Module 2.8 Investigators responsibilities -Informed consent

Module 2.10 Investigators responsibilities IP Management

Module 2.11 -2.13 Investigators responsibilities -Other

Module 3. Sponsor

Module 3.1-3.9 Sponsor Responsibilities

Module 3.10. Sponsor Responsibilities – Quality Management

Module 3.13-3.15 Sponsor Responsibilities, Safety, Insurance and IP

Module 3.16-3.17: Sponsor Responsibilities – Data and Records

Module 4. Data Governance

Data Governance

Module 5. APPENDICES
This section outlines the three appendices as per R3, the Investigator’s Brochure (Appendix A), the Clinical trial protocol (Appendix B), and any applicable protocol amendments (Appendix C). Additionally, it includes session records (Appendix C).

Appendix A. Investigator’s Brochure

Appendix B. Clinical Trial Protocol and Protocol Amendments

Appendix C. Essential records for conducting a clinical trial

ICH E6(R3) Guideline- Exam

ICH GCP Exam

Copyright © 2023 Afrileadtech | Powered by TSWELOPELE INNOVATION DIVISION

About Course

Course Content

Introduction to ICH GCP E6 (R3) Good Clinical practice The module introduces ICH GCP E6 (R3) Good Clinical Practice. It begins with an overview of the changes from R2 to R3.

Module I. Introduction to R3 Good Clinical Practice

Module II: The ICH E6(R3) principles,

Module 1: Institutional Review Board/ Independent Ethics Committee

Module 2. Investigators The section outlines the investigator responsibilities from 2.1 to 2.13.

Module 2.1-2.7 Investigators responsibilities

Module 2.8 Investigators responsibilities -Informed consent

Module 2.10 Investigators responsibilities IP Management

Module 2.11 -2.13 Investigators responsibilities -Other

Module 3. Sponsor

Module 3.1-3.9 Sponsor Responsibilities

Module 3.10. Sponsor Responsibilities – Quality Management

Module 3.13-3.15 Sponsor Responsibilities, Safety, Insurance and IP

Module 3.16-3.17: Sponsor Responsibilities – Data and Records

Module 4. Data Governance

Data Governance

Module 5. APPENDICES This section outlines the three appendices as per R3, the Investigator’s Brochure (Appendix A), the Clinical trial protocol (Appendix B), and any applicable protocol amendments (Appendix C). Additionally, it includes session records (Appendix C).

Appendix A. Investigator’s Brochure

Appendix B. Clinical Trial Protocol and Protocol Amendments

Appendix C. Essential records for conducting a clinical trial

ICH E6(R3) Guideline- Exam

ICH GCP Exam

Student Ratings & Reviews

Copyright © 2023 Afrileadtech | Powered by TSWELOPELE INNOVATION DIVISION

Introduction to ICH GCP E6 (R3) Good Clinical practice
The module introduces ICH GCP E6 (R3) Good Clinical Practice. It begins with an overview of the changes from R2 to R3.

Module 2. Investigators
The section outlines the investigator responsibilities from 2.1 to 2.13.

Module 5. APPENDICES
This section outlines the three appendices as per R3, the Investigator’s Brochure (Appendix A), the Clinical trial protocol (Appendix B), and any applicable protocol amendments (Appendix C). Additionally, it includes session records (Appendix C).