ICSR (Individual Case Safety Report)
What is it?
An ICSR is the structured record of a single adverse event affecting a single patient, built from a report that came in through triage, case processing, and causality assessment. It's the atomic unit pharmacovigilance runs on: every downstream activity, from signal detection to PSUR line listings to regulatory submissions, is built by aggregating ICSRs, not raw reports.
What makes an ICSR useful beyond your own case-management system is the format it's built in. ICSRs follow the E2B(R3) standard, an internationally agreed structure that lets a case created in one company's safety database transfer cleanly into a regulator's system or a global database like EudraVigilance or VigiBase, without anyone re-keying the data by hand.
Same case, before and after
An ICSR isn't a new report, it's the same case, reorganized. Flip the switch to watch it happen.
Toggle to see the structured record"Patient felt dizzy and fainted two days after starting the new tablets. GP gave IV fluids, patient recovered within the hour. No history of fainting before."
One report can produce more than one ICSR. A follow-up with new medical information doesn't get bolted onto the original. It's submitted as a linked, updated ICSR, so the full history of how a case evolved stays traceable.
Common Misconceptions
"So the ICSR is just the report the doctor or patient sent us?"
The incoming report is only the raw input. The ICSR is what your team produces from it: triaged, coded to MedDRA terms, assessed for causality and seriousness. That's why a single messy report can still turn into a clean, exchangeable record.
