Adverse Event Reporting Timelines
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Expedited Reporting:
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Regulatory authorities require expedited reporting for serious and unexpected adverse events during clinical trials.
- Serious Adverse Events (SAEs):
- Timeline: Must be reported to the sponsor immediately (typically within 24 hours of becoming aware of the event).
- The sponsor is responsible for further reporting to regulatory authorities (e.g., FDA, EMA) within 7 days for life-threatening or fatal events and 15 days for other serious events.
- Suspected Unexpected Serious Adverse Reactions (SUSARs):
- Timeline: Sponsors must report life-threatening or fatal SUSARs to regulatory authorities within 7 days and provide follow-up information within 8 days.
- Non-life-threatening SUSARs should be reported within 15 days.
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Non-Serious Adverse Events:
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These events are generally reported in the study’s final report or during periodic safety updates rather than on an expedited basis.
- Non-Serious AEs:
- Typically recorded and monitored but not subject to expedited reporting unless required by the protocol or the regulatory authority.
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3. Responsibilities for Adverse Event Reporting
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Investigators:
- Primary Responsibility: The investigator is responsible for identifying and documenting AEs and SAEs during the clinical trial.
- AE Reporting: The investigator must report all SAEs immediately to the sponsor, usually within 24 hours of becoming aware of the event.
- Follow-Up: The investigator must provide follow-up information to the sponsor to complete the AE or SAE report.
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Sponsors:
- Sponsor’s Role: The sponsor is responsible for the prompt assessment of all AEs and SAEs, determining causality, and reporting SUSARs to regulatory authorities.
- Expedited Reporting: Sponsors must submit reports of SUSARs and other reportable SAEs to regulatory agencies within the required timelines.
- Annual Safety Reporting: Sponsors are often required to submit annual safety reports (e.g., DSUR—Development Safety Update Report) summarizing all AEs and SAEs observed during the trial.
