RCR: ICH E6 (R3): Understanding the Revision of the International Council on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) in Clinical Trials

Presented by Shirley Longinotti, BA, Research Education Facilitator, CTSI  

The International Council for Harmonisation (ICH) was assembled to address the divergence of regulatory and technical requirements for pharmaceutical development from country to country. ICH created harmonized regulatory/industry guidelines relating to Quality, Safety and Efficacy as well as common terminology and data and electronic standards for information transfer which are followed by NIH, FDA and other international sponsors. 

This session will focus on Section 6 of the Efficacy guideline (ICH E6) which addresses Good Clinical Practice (GCP) in the design, conduct, safety and reporting of clinical trials.  The section was recently revised (ICH E6(R3), and the session will cover key changes from ICH E6 (R2) and the implications for those involved in clinical research.  (subject matter: human participant research)