The International Council for Harmonisation (ICH) published a revision to GCP E6 based on feedback from the global clinical research community, advancements in technology and risk management developments. ICH states that the goal of the changes is to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct oversight, recording, and reporting while continuing to insure human subject protection and data integrity”. This presentation will address the amendments and additions to the investigator responsibilities at a research site as well as best practices to meet those requirements.
This course requires membership in SOCRA.
View course here.