adverse-event-reporting-policy

name	adverse-event-reporting-policy
title	Adverse Event Reporting Policy
description	Drafts an Adverse Event Reporting Policy compliant with 21 CFR 312.32 (IND safety reporting), 21 CFR 314.80 (postmarketing), and ICH E2A, with multi-jurisdictional overlays (EMA, PMDA, Health Canada). Covers seriousness/causality frameworks, expedited reporting timelines, roles, documentation standards, training mandates, and QA mechanisms. Use when drafting or updating an adverse event reporting policy, pharmacovigilance policy, AE/SAE reporting SOP, or safety reporting framework for a pharmaceutical company, CRO, biotech, or clinical research institution.
author	CaseMark
author_url	https://github.com/CaseMark/skills/tree/main/skills/legal/adverse-event-reporting-policy
license	Apache-2.0
version	0.1.0
execution_mode	open
jurisdiction	us
practice	life-sciences
language	en
tags	["drafting","policy"]

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

• Cite controlling regulations:
  • 21 CFR 312.32 — IND safety reporting
  • 21 CFR 314.80 — Postmarketing adverse drug experience
  • ICH E2A — Clinical safety data management
  • 21 CFR 803 — Medical device reporting (if applicable)
  • Applicable state and international requirements
• Effective date, review cycle (annual minimum), approval authority
• Binding compliance statement: policy adherence is condition of employment; violations may constitute federal law violations

Step 2: Definitions

Include at minimum:

Term	Definition
Adverse Event (AE)	Any untoward medical occurrence; causal relationship need not be established
Serious Adverse Event (SAE)	Meets ≥1 of 6 FDA/ICH seriousness criteria
Unexpected AE	Not in current IB, package insert, or reference safety information by nature, severity, or frequency
Suspected Adverse Reaction	Reasonable possibility of causal relationship
Causality Assessment	Systematic evaluation using validated algorithm (Naranjo, WHO-UMC)
Sponsor Awareness	When sponsor employee first receives AE information — starts all reporting clocks