New GCP Guidelines: How does it impact me?
Wednesday, July 11, 2018
This presentation will describe updates to the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E6 Guideline, referred to as R2. The proposed revisions will modernize and encourage implementation of more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. This presentation will review the changes and how they will impact the PI and members of the study team.