In 2018, for the first time in over 20 years, the International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 R2 Guideline was significantly updated. The revisions are intended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results. But, the changes have resounding effects on the conduct of clinical research by sponsors/CROs and investigators. As such, systematic analysis to ensure adherence to these clinical trial standards is essential.
This website is dedicated to providing resources that can assist companies in reinforcing the core concepts of Good Clinical Practice (GCP) application of GCP principles including ICH GCP E6 R2. Included are a number of training courses, webinars, self-paced learning modules and publications that assist industry professionals in navigating the myriad of changes associated with the ICH revision.
AREAS IMPACTED BY THE UPDATE INCLUDE:
2. Sponsor system for managing trial quality: risk-based/risk management approaches to clinical trials – is now a *requirement*- all clinical trials
3. Sponsor oversight of CROs, and written approval of CRO sub-contractors *new*
4. Certified Copy definition *new*
5. Computerized Systems Validation definition *new *
6. Monitoring Plan definition *new*
7. Monitoring Plan: rationale for chosen monitoring strategy *new*
8. Centralized Monitoring *new*
9. Sponsor Monitoring Report review *new*
11. Computerized Systems Validation requirements *new*
12. Investigator responsibilities *new requirements*-source data, supervision, third party oversight ALCOA – addition of the C for complete! *new*
13. Investigator significant non-compliance: sponsor implement root cause analysis and CAPA, serious breach reporting *new*
14. Updated ICH Principle for clinical trial information