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The required reporting of safety information to Institutional Review Boards or Ethics Committees overseeing clinical trials.
A SUSAR requires notification to all IRBs overseeing sites where the product is being studied within the required timeframe (often 7-15 days).
ICH E6, 21 CFR 312.32
Not tracking IRB notification timelines separately from regulatory authority timelines, or failing to notify all relevant IRBs.
How do you track IRB notifications for SUSARs? Demonstrate compliance for a recent case.