ICSR
Also known as: Individual Case Safety Report, adverse event report, case report
An ICSR is the structured record of an adverse event experienced by a single patient with a single medicine, and it is the unit of exchange in pharmacovigilance — the format regulators require for reporting safety data.
The four validity criteria
A report only becomes a reportable ICSR when four elements are present:
- An identifiable patient
- An identifiable reporter
- A suspect medicinal product
- An adverse event
Miss any one and it is not yet a valid case — but the obligation to follow up and try to obtain the missing element is real, and failure to chase is itself a finding.
E2B: the exchange standard
ICSRs move between companies and regulators in ICH E2B format. The current version, E2B(R3), is XML-based and replaced the older R2 message. It carries considerably more structure — better handling of parent-child cases, drug dosage detail, and null flavours that distinguish "unknown" from "not applicable", a distinction R2 could not express.
The clocks
| Case type | Typical deadline |
|---|---|
| Serious, unexpected, suspected reaction | 7 or 15 calendar days by region |
| Serious, expected | 15 calendar days |
| Non-serious | Periodic, in aggregate reports |
The clock starts at day zero — the first moment anyone in the organisation, including a sales representative, became aware of the four criteria. This is why awareness-date discipline dominates pharmacovigilance training: a case discovered in an inbox weeks later may already be late on arrival.
Where effort concentrates
Most of the cost is case intake and data entry: reading unstructured narratives, coding events to MedDRA, coding products to a dictionary, assessing seriousness, and chasing follow-up. It is the single largest line item in most PV operations, and the reason automation attempts cluster there.
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Related terms
Last reviewed 2026-08-05