The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practie fundamentally reframes the role of principal nvestigators (PIs) in clinical trial oversight—moving beyond task delegation to genuine, demonstrable accountability. Yet across sites and institutions, the most common response to E6(R3) has been procedural: updating the Delegation of Authority log and moving on.

This session challenges that approach. Drawing on real-world monitoring and audit scenarios across Phases I–IV, this advanced session examines what genuine PI oversight looks like in practice—and where the gaps between regulatory intent and site-level execution create the most significant compliance risk.

Topics include the distinction between task delegation and oversight delegation, PI accountability for data integrity and safety reporting, and how sites can build infrastructure that makes PI oversight visible, documentable, and sustainable under E6(R3) scrutiny. Attendees will leave with a framework for translating E6(R3)'s strengthened investigator requirements into operational site standards.

CEU: 1.0 ACRP

Speaker:

• Andrea Arruda, Principal Consultant & Founder, pharmaDev Consulting