Adverse Event Reporting Policy

Drafts a binding AE reporting policy meeting FDA requirements and ICH standards for pharma, biotech, CROs, and healthcare organizations conducting or sponsoring clinical research.

Prerequisites

Gather before drafting. If any item is missing, pause and ask — do not assume.

1. Organization type — pharmaceutical sponsor, CRO, healthcare system, academic medical center, or combination
2. Product portfolio — IND products (Phase I–IV), approved drugs, biologics, devices, combination products, REMS-covered products
3. Geographic footprint — domestic only vs. multi-jurisdictional (EU, Japan, Canada, etc.)
4. Therapeutic areas — flag specialized populations: oncology, vaccines, biologics, pediatrics
5. Existing SOPs — current pharmacovigilance SOPs, IRB agreements, DSMB charters to cross-reference

Step 1: Introduction & Compliance Statement