Introduction | Seminar Schedule & Registration | Reportable Events Forms | Frequently Asked Questions (FAQ)
New Reportable Events Policy
This page contains information about the new Reportable Events Policy which replaces 3 existing policies (Internal Adverse Event Policy, External Adverse Event Policy, and Protocol Deviation Policy and Procedure). Effective immediately, all events covered under this policy should be submitted using the new forms.
Reportable Events Forms
Submit Reportable Events for studies approved in iRIS using the forms in iRIS. For studies approved outside of iRIS (PATS or paper), use the paper forms below:
- Reportable Event Form – For filing an initial report of a reportable event (except for Protocol Exception requests – see separate form below).
- Reportable Event Follow-Up Report – For providing additional outcome information related (not available at the time of the initial report).
- Protocol Exception Request Form – For requesting IRB approval to of a temporary deviation from the protocol prior to implementation, e.g., enrollment of a subject who does not meet the eligibility criteria.
- AE Log – This is a sample log that you may use to record adverse events as required under the policy. Note: For greater than minimal risk studies, the log must be submitted to the IRB as part of the annual review of the protocol.
- Deviation Log – This is a sample log that you may use to record deviations as required under the policy. Note: For greater than minimal risk studies, the log must be submitted to the IRB as part of the annual review of the protocol.
Frequently Asked Questions (FAQ)
- What about PATS?
- All Reportable Events associated with studies in PATS will be submitted using the paper forms above - the AE forms in PATS will no longer be used. AEs already being prepared/processed in PATS may be completed in PATS.
- What if the paper AE form was already filled out/signed?
- The IRB will continue to accept the old AE and deviation forms through 8/31/13.
- Do I still have to submit "48-hour notices" to the IRB by email?
- No. However, reportable events must be submitted to the IRB within 5 business days.
- What about all the events that used to be reportable?
- While they don't need to be reported promptly, IRB policy requires that you log all adverse events (AE), unanticipated problems (UP), and protocol deviations or errors (PD) events that comes to the attention of the research staff responsible for the research. "Full review" (greater than minimal risk studies) are also required to submit a copy of the log(s) with each progress report.
- Do I still need to submitted all External AEs for acknowledgement?
- No, only external events that qualify as reportable events need to be submitted to the IRB.
- Am I required to use the IRB's AE and Deviation Logs?
- No. The IRB's logs are samples/templates. You may modify them to suit your protocol or use other logs (e.g. those provided by the sponsor of your study).
- When do I need to submit a follow-up report?
- A follow-up report can be required in the following circumstances:
- At the request of the IRB (this request is usually made in the acknowledgement letter for the original reportable event)
- There is more information about the event to be provided to the IRB (e.g. the resolution of the event is now known)
- The Data Safety Monitoring Committee/Board has reviewed the event, and this review is being submitted to the IRB
- If a subject dies (unrelated to the study, e.g. progression of underlying disease) should this be reported to the IRB?
- Yes, if the death is within 30 days of a protocol intervention
- If the death is related to a previously reported event, submit this as a follow-up report
- Otherwise, submit as a new event
- Can someone other than the PI sign off on a reportable event submission?
- Generally the PI must sign-off and for iRIS is able to do so from anywhere s/he can access a computer with an internet connection. In extenuating circumstances, contact the IRB for guidance.
- What if I have additional questions about the new policy or forms?
- Contact the IRB.