ICSR
Individual Case 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.
The standardized format for reporting information about a single case of a suspected adverse reaction to a medicinal product, whether arising in a clinical trial, from spontaneous post-marketing reports, or from the literature. The ICSR structures patient, reaction, product, and reporter information for consistent, machine-processable electronic transmission between sponsors, regulators, and safety databases.
The ICSR is the atomic unit of case-level pharmacovigilance — one report per suspected adverse reaction case — distinct from an aggregate safety report, which evaluates many cases together for trends.
It is structured for electronic transmission using the ICH E2B(R3) format, allowing consistent exchange between sponsor safety databases and regulatory repositories such as FDA’s FAERS and EMA’s EudraVigilance, without manual reformatting at each transfer.
A case commonly evolves: initial information is supplemented as follow-up details arrive, and each update is submitted as a follow-up or amended ICSR tied to the same underlying case, not treated as a new, independent report.
- —The atomic unit of case-level safety reporting — one ICSR per suspected adverse reaction case.
- —Structured for electronic transmission using the ICH E2B(R3) format to safety databases such as FAERS and EudraVigilance.
- —Contains standardized patient, product, MedDRA-coded reaction, and reporter data elements.
- —Follow-up information on the same case is submitted as a follow-up or amended ICSR, not a new independent case.
ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports; ICH E2A Clinical Safety Data Management
Frequently asked questions
What does ICSR stand for?
ICSR stands for Individual Case Safety Report.
What is ICSR?
The standardized format for reporting information about a single case of a suspected adverse reaction to a medicinal product, whether arising in a clinical trial, from spontaneous post-marketing reports, or from the literature. The ICSR structures patient, reaction, product, and reporter information for consistent, machine-processable electronic transmission between sponsors, regulators, and safety databases.
Which regulations cover ICSR?
ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports; ICH E2A Clinical Safety Data Management