29  Safety & Pharmacovigilance

29.1 Purpose

This module defines the CRA’s role in safety oversight and pharmacovigilance during clinical trial conduct.

29.2 CRA Accountability (Practical)

• Confirm site awareness of safety reporting obligations
• Verify documentation of AEs/SAEs is complete and timely
• Ensure follow-up information is obtained and documented
• Identify safety trends or systemic issues and escalate appropriately

29.3 Scope

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