The International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice is reshaping expectations for site readiness, documentation, and access to trial records. This session will prepare clinical research professionals to distinguish between routine interim monitoring visits, audits, and inspections, and to understand what their respective expectations mean in practice. Attendees will review what remains foundational, including timely institutional review board reporting, documentation readiness, and investigator site file maintenance, while examining areas of increased emphasis such as electronic system validation, audit trails, direct access to source documents and site facilities, and inspection-ready processes.

The session will also address practical considerations for pre-study visits, site initiation visits, and interim monitoring visits, including what site teams and partners should confirm before monitoring, audit, or inspection activity occurs. Attendees will leave with a clearer framework for preparing sites, identifying readiness gaps, and supporting compliant, well-documented clinical trial conduct.

CEU: 1.0 ACRP

Speaker:

• Lella Baker, Sr. Consultant, GxP Services