8  Regulatory Compliance

8.1 Purpose

This module defines the CRA’s role in ensuring regulatory compliance and maintaining inspection-ready documentation at the site and in the TMF.

8.2 CRA Accountability (Practical)

• Confirm required documents are current, complete, and consistent across systems
• Verify approvals (IRB/IEC) and version control for ICF/protocol
• Ensure delegation and training documentation supports all trial activities
• Identify gaps early and drive timely resolution with documented follow-up

8.3 Scope

Applies to all interventional trials. Therapeutic-area considerations (oncology, infectious disease) are highlighted where relevant.