Module 5 Presentations

05/07/2024

ICH GCP Guideline E6

• Adopted 1 st May 1996, applicable from January 1997.

• ”An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki , and that the clinical trial data are credible”. Basic reference document for all clinical trials today • Guideline for good clinical practice E6(R2) – came into effect 14 June 2017 • Revision E6(3) under preparation, should come into effect 2025. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Guideline_GCP_Video_2023_0601.mp4

The Organisation for Professionals in Regulatory Affairs

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ICH GCP Guideline E6 – Revision R2

Why: Modernized to keep pace with the scale and complexity of clinical trials and to ensure appropriate use of technology.

• Detailed approach to best practices for stakeholders to follow during their involvement in the clinical trial process • Discussion of quality management and risk-based monitoring • New and updated definitions • Additional investigator and sponsor responsibilities • Updated standards for electronic records and essential documents • Addresses the life cycle of a clinical trial within a drug development programme and serves as a roadmap to oversight

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