ICH GCP Goes Risk-Based

GCP Addendum Review and Embracement Plan

by Artem Andrianov, PhD, Beat Widler, PhD, Maria Proupín-Pérez, PhD

AppliedClinicalTrials, May 2015: The new upcoming GCP E6 (R2) addendum has the potential to reform clinical monitoring and clinical trial management. What changes does it bring to all of us? What does this mean for a pharmaceutical company, for a Contract Research Organization (CRO) and for an investigator in terms of changes to the processes of trial oversight, data collection and reporting and trial design and planning? In this article, you will find a structured summary and critical review of the new addendum, and as well as ideas on how to prepare for these regulatory changes.