Individual Event Reporting
An individual event needs to be reported to the UAMS Institutional Review Board only if all of the following are true:
- It is unexpected
- It is related to the research
- It involves increased risk to subjects or others
If an individual event meets these criteria, it must be reported to the Institutional Review Board using a Reportable New Information form in Clinical Research Administration (CLARA), either immediately (if it results in death or is life-threatening) or within 10 days of the event.
Note: Institutional Review Board reporting requirements are described in Institutional Review Board Policy 10.2
Summary Event Reporting
Events that do not meet the criteria for individual reporting outlined above should be reported in summary at continuing review, when applicable. (Note that many newly approved minimal risk studies no longer require continuing review, under the Revised Common Rule.)
The Institutional Review Board encourages use of our Events and Deviations Tables when doing summary reporting of events. The Institutional Review Board also strongly encourages study teams to track events and deviations throughout the year, to be able to identify any trends earlier and to improve the accuracy of year-end reporting.
Some sponsors may ask that all safety reports be submitted to the Institutional Review Board immediately, even if they do not meet the criteria for individual reporting. The memo regarding UAMS requirements for reporting Unanticipated Problems Involving Risks to Subjects or
Others (UPIRTSOs) and IND safety reports can be shown to study sponsors to advise them of the UAMS Institutional Review Board’s reporting expectations.