WIRB Adverse Event Reporting System
Federal Regulation 21CFR 56.108(b)(1) requires the IRB to "follow written procedures for ensuring prompt reporting to the IRB…of…Any unanticipated problems involving risks to human subjects or others..."
Investigators are required to report adverse events that fit
the following criteria within 10 working days of the time the investigator
becomes aware of them:
- Event is UNANTICIPATED (an unanticipated event is any adverse
experience where the nature, severity or frequency is not identified
in the investigator brochure or described in the protocol. Events
which are already cited in the investigator brochure or protocol are
not unanticipated and do not have to be reported to WIRB),
AND
- Event is POSSIBLY RELATED to the study design, procedures, or drug/device. If the adverse
event is clearly not related to the study drug, device, procedures,
or washout process, it would not represent a risk to other subjects
in the research and, therefore, does not have to be reported to WIRB.
Sites must use the WIRB Ten Day Adverse Event form. The form is available on the Download Forms page.
Please note that WIRB no longer uses an AE Log form. All AEs which fit the criteria above must now be reported using the Ten Day form.
If the Sponsor, CRO or SMO does not submit IND or other safety reports to WIRB on behalf of your site, you are required to submit them within 10 days of the date you receive them.
The reporting requirements for WIRB may differ from the reporting requirements for the sponsor.
Unnecessarily reporting events or problems that do not potentially affect the rights, welfare or safety of subjects in the study may impair the Board's ability to review and respond in a timely manner to actual situations where subject rights, welfare or safety are threatened.
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