Individual Case Safety Report (ICSR)

An Individual Case Study Report is an adverse event report for an individual patient.

Individual Case Safety Report (Synonym with Adverse Drug Reaction Report)

Individual Case Safety Report is a document in a specific format for the reporting of one or several suspected adverse reactions to a medicinal product that occur in a single patient at a specific point of time.

Individual Case Safety Report in the European Union

All of the available supporting documentation for the event must be described in this report.

For reporting purposes, done electronically in EU/EEA, the ICSR should contain the following 4 basic elements: An identifiable patient/subject; An identifiable reporter, A suspect drug or biological product, An adverse event or fatal outcome.

If any of these basic elements remain unknown after being actively sought by the applicant, manufacturer, or licensed manufacturer, the ICSR should not be submitted to the Competent Regulatory Authorities, but used in other pharmacovigilance activities such as, but not limited to, signal detection and PSUR reporting.