TheIndividual Case Safety Report (ICSR)is the standard format used globally for the exchange ofSerious Adverse Event (SAE)data between clinical data management systems (EDC) and safety management systems.
According toICH E2B(R3)andGood Clinical Data Management Practices (GCDMP, Chapter: Safety Data Management and SAE Reconciliation), the ICSR provides thedata structure and content standardsfor electronic transmission of safety data, including patient demographics, event details, outcomes, and product information. It ensures interoperability between systems by defining standardized message elements and controlled terminologies.
Other options are not applicable:
A. Medical Document for Regulatory Activities (MDRA)is not a recognized standard.
B. Biomedical Research Domain Model (BRIDG)provides conceptual modeling but not data exchange guidance.
D. SDTMis used for regulatory submission datasets, not real-time SAE exchange.
Thus,option C (Individual Case Safety Report)is correct, as it defines the internationally accepted electronic format for SAE data exchange between safety and clinical databases.
Reference (CCDM-Verified Sources):
SCDM GCDMP, Chapter: Safety Data Management and SAE Reconciliation, Section 4.3 – SAE Data Exchange and Standards
ICH E2B(R3): Electronic Transmission of Individual Case Safety Reports
FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Postmarketing ICSRs (2014)
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