Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
The ICH guideline establishing the definitions (serious, unexpected, adverse reaction) and standards for expedited safety reporting during clinical development. E2A defines the SUSAR concept and the 7-day (fatal/life-threatening) and 15-day expedited reporting timelines that regulators worldwide adopted.
Safety data management for investigational products during clinical trials in ICH regions. Complemented by E2B (transmission), E2D (post-approval definitions), and E2F (DSUR).
When an individual case must reach regulators during clinical development.
| Case | Initial report | Follow-up |
|---|---|---|
| Fatal or life-threatening, serious, unexpected adverse reaction | 7 calendar days | Complete report within 8 further calendar days |
| Other serious, unexpected adverse reaction | 15 calendar days | As new information becomes available |
“Serious” = death, life-threatening, hospitalisation (initial or prolonged), persistent or significant disability/incapacity, or a congenital anomaly/birth defect. “Unexpected” = not consistent with the reference safety information (e.g. the Investigator’s Brochure). US IND safety reports codify the same 7- and 15-day clocks in 21 CFR 312.32.
Source: ICH E2A, expedited reporting standards. Verify against the current text before relying on it for a submission.
- 01Apply consistent definitions of serious, unexpected, and related adverse events
- 02Expedite SUSAR reports within 7 or 15 calendar days as applicable
- 03Assess expectedness against the reference safety information
Adopted in 1994; remains the definitional basis for expedited clinical-trial safety reporting, implemented through E2B and regional regulations.
ICH E2A: frequently asked questions
Quick answers to common questions about ICH E2A.
What is ICH E2A?
ICH E2A — Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — is a guidance issued by the International Council for Harmonisation. The ICH guideline establishing the definitions (serious, unexpected, adverse reaction) and standards for expedited safety reporting during clinical development. E2A defines the SUSAR concept and the 7-day (fatal/life-threatening) and 15-day expedited reporting timelines that regulators worldwide adopted.
Who does ICH E2A apply to?
Safety data management for investigational products during clinical trials in ICH regions. Complemented by E2B (transmission), E2D (post-approval definitions), and E2F (DSUR).
What are the key requirements of ICH E2A?
ICH E2A requires, among other things: Apply consistent definitions of serious, unexpected, and related adverse events; Expedite SUSAR reports within 7 or 15 calendar days as applicable; Assess expectedness against the reference safety information.
When was ICH E2A last updated?
The current version of ICH E2A dates from October 1994. Adopted in 1994; remains the definitional basis for expedited clinical-trial safety reporting, implemented through E2B and regional regulations.
Track the standards that move
When ICH E2A — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.