Expedited Reporting
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
The regulatory requirement to notify health authorities, investigators, and ethics committees of certain serious safety findings — chiefly SUSARs — within tightly defined timelines, separate from routine periodic safety reporting. Expedited reporting enables fast risk communication so investigators and regulators can act before the next scheduled safety update.
Expedited reporting is event-driven: a qualifying case triggers a report within days, in contrast to periodic reports such as the DSUR, which follow a fixed calendar schedule regardless of whether a new safety finding has occurred in the interim.
Reporting clocks are typically tiered by severity, with fatal or life-threatening events subject to a shorter timeline than other qualifying serious events, reflecting the differing urgency of the risk communicated.
Assessing a case for expedited reporting may require unblinding that individual case — but not the wider trial — so causality and expectedness can be properly judged without compromising the blind for everyone else.
- —Event-driven, unlike periodic reports such as the DSUR, which follow a fixed calendar schedule.
- —Reporting clocks are typically shorter for fatal or life-threatening events than for other qualifying serious events.
- —May require unblinding of the individual case, not the whole trial, to assess causality and expectedness.
- —Applies to sponsors reporting to regulators and to investigators and ethics committees receiving sponsor safety notifications.
ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; 21 CFR 312.32 (IND Safety Reporting); EU Regulation 536/2014 (CTR)
Frequently asked questions
What is Expedited Reporting?
The regulatory requirement to notify health authorities, investigators, and ethics committees of certain serious safety findings — chiefly SUSARs — within tightly defined timelines, separate from routine periodic safety reporting. Expedited reporting enables fast risk communication so investigators and regulators can act before the next scheduled safety update.
Which regulations cover Expedited Reporting?
ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; 21 CFR 312.32 (IND Safety Reporting); EU Regulation 536/2014 (CTR)