Aggregate Safety Report
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.
A periodic compilation and evaluation of all safety information accumulated for an investigational product over a defined interval, as distinct from single-case expedited reports. Aggregate reports examine the full safety dataset to detect patterns, evaluate the evolving benefit-risk profile, and are submitted to regulators on a recurring schedule throughout development and after approval.
Where an expedited report communicates a single alarming case quickly, an aggregate report steps back and evaluates the whole accumulated safety dataset together — patterns, rates, and trends that are invisible in any one case become visible when cases are pooled and compared over time.
The Development Safety Update Report (DSUR) is the aggregate report used during clinical development; post-approval, the Periodic Benefit-Risk Evaluation Report (PBRER, historically called the PSUR) serves the equivalent function for a marketed product.
Findings surfaced through aggregate review — a rising rate of a particular event, an emerging class effect — can trigger a protocol amendment, an updated informed consent form, or a revision to the Investigator’s Brochure.
- —Complements expedited single-case reporting by evaluating safety data in aggregate, where patterns and trends become visible.
- —The Development Safety Update Report (DSUR) is the aggregate report used during clinical development.
- —Post-approval, the Periodic Benefit-Risk Evaluation Report (PBRER/PSUR) serves the equivalent aggregate function.
- —Findings from aggregate review can trigger a protocol amendment, updated informed consent, or an IB revision.
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report; ICH E2F Development Safety Update Report
Frequently asked questions
What is Aggregate Safety Report?
A periodic compilation and evaluation of all safety information accumulated for an investigational product over a defined interval, as distinct from single-case expedited reports. Aggregate reports examine the full safety dataset to detect patterns, evaluate the evolving benefit-risk profile, and are submitted to regulators on a recurring schedule throughout development and after approval.
Which regulations cover Aggregate Safety Report?
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report; ICH E2F Development Safety Update Report