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SUSAR triage with the safety database
A SUSAR is a suspected unexpected serious adverse reaction. Three tests have to be true: serious, unexpected against the reference safety information, and suspected of being related. AE Connect drafts the inputs to those tests and integrates the case with any safety database. That database remains the system of record.
What triage looks like here
The draft flags seriousness and expectedness and proposes a WHO-UMC causality term. A reviewer accepts or overrides each one. The timeline in the draft is a prompt for the 7-day and 15-day clocks a qualified person already knows from 21 CFR 312.32 and ICH E2A. The software does not start the regulatory clock. AE Connect integrates the reviewed case with any safety database, which remains the system of record.
Where the SUSAR is filed
The safety database or the CRO named in the pharmacovigilance plan remains the system of record. AE Connect integrates the reviewed case with that database, including Oracle Argus, ArisGlobal LifeSphere, Veeva Vault Safety, and others. Read the SUSAR reporting guide for the clocks, and aggregate reports for why one SUSAR is not a DSUR.
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Questions
Does AE Connect submit a SUSAR?
AE Connect drafts seriousness, expectedness, and causality for a person to review, then integrates the case with any safety database. That database remains the system of record.
Does a SUSAR replace the DSUR?
No. Expedited cases and the annual development safety update are different documents. The annual report stays outside AE Connect.
Which safety database does the filing?
The one your plan names. AE Connect integrates with that safety database, and with any other. It remains the system of record.