ICH E2 Clinical Safety Data Management Guidelines

The ICH E2 family contains the principal harmonised international guidelines for clinical and post-authorisation safety data management.

Core E2 documents

• E2A — definitions and standards for expedited reporting in clinical development.
• E2B(R3) — data elements and electronic transmission standards for individual case safety reports.
• E2C(R2) — Periodic Benefit-Risk Evaluation Report (PBRER).
• E2D — post-approval safety data management.
• E2E — pharmacovigilance planning.
• E2F — Development Safety Update Report (DSUR).

ICH guidelines require implementation through regional regulatory frameworks. Their legal or procedural effect therefore depends on the jurisdiction in which they are applied.