What are typical timelines for expedited reporting of serious adverse events to IRB and sponsor?

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Multiple Choice

What are typical timelines for expedited reporting of serious adverse events to IRB and sponsor?

Expedited reporting focuses on getting safety information to the right people quickly so participant protections can be updated without delay. For serious adverse events that are life-threatening or require urgent action, the investigator must alert the sponsor and the IRB promptly—typically within 24 hours—by the fastest practical means, often with an initial brief report. A more complete narrative with details about the event, the assessment of its relationship to the study, outcomes, and corrective actions should follow within a short window, commonly 7 to 15 days. While exact timelines can vary by country, institution, or regulatory body, this pattern—immediate notice for life-threatening events and a fuller report within about one to two weeks—is widely expected. Other options don’t fit because delaying notification for 60 days misses the safety urgency, claiming no fixed timeline ignores regulatory requirements, and saying only the sponsor must be informed omits the IRB’s important oversight role.

Expedited reporting focuses on getting safety information to the right people quickly so participant protections can be updated without delay. For serious adverse events that are life-threatening or require urgent action, the investigator must alert the sponsor and the IRB promptly—typically within 24 hours—by the fastest practical means, often with an initial brief report. A more complete narrative with details about the event, the assessment of its relationship to the study, outcomes, and corrective actions should follow within a short window, commonly 7 to 15 days. While exact timelines can vary by country, institution, or regulatory body, this pattern—immediate notice for life-threatening events and a fuller report within about one to two weeks—is widely expected.

Other options don’t fit because delaying notification for 60 days misses the safety urgency, claiming no fixed timeline ignores regulatory requirements, and saying only the sponsor must be informed omits the IRB’s important oversight role.

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