ICH- GCP E6 R2 (Addendum) & its Implication on Stakeholders

Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities. When the original ICH E6(R1) text was prepared, clinical trials were performed in a largely paper-based process.  Advances in use of electronic data recording and reporting facilitate implementation of other approaches.This training module aims to support the development of a fundamental understanding of revision of ICH-GCP E6 R2. This session is aimed at Clinical Operations members, and other functions involved in Clinical Research. The objective of the session is to understand the difference and its implication for various stakeholders.


Session Date: 12 August 9:00 - 13:00

Course details:

Understanding ICH-GCP Background & Objective of Revision

Content Changes in ICH-GCP révision

Implications for stakeholders

Highlights différences Old Vs new version

Practise through Question Bank


Course Details   Duration (hours)
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