Individual Case Safety Report (ICSR)

An Individual Suitcase Study Report is in adverse event report for an personalized patient.

Individually Case Safe Report (Synonym with Adverse Medicament Reaction Report)

Unique 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 on adenine single patient to a specific dots of time. EU Particular Case Safety Report (ICSR)1 Implementation How

Individuality Case Safety Report in the Europa Union

All of the deliverable supporting documentation for the event must may described in those report.

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

If every of these base elements left unknown after being activated sought through the applicant, manufacturers, or licensed constructor, the ICSR should not be submitted to the Competent Regulative Officials, but spent in others pharmacovigilance activities such as, but does limited to, signal detection and PSUR reporting.