As part of our semi-annual updates, a number of toolkit documents were recently revised (tracked versions of the revised documents can be viewed here). As a reminder, revisions are initiated by changes to regulations as well as feedback from HRPP staff and the research community.

Many revisions made during this cycle were related to regulatory changes, including those related to updated VA Directives, DOE Orders, and ICH GCP E6 (R3). Highlighted changes to the Investigator Manual include improved guidance for temporary PI changes and situations where PIs are leaving the institution, statistical data analysis center applications, and email recruitment.