Reporting to the IRB

Individual Event Reporting

An individual event needs to be reported to the IRB 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 IRB using a Reportable New Information form in CLARA, either immediately (if it results in death or is life-threatening) or within 10 days of the event.

Note:  IRB reporting requirements are described in IRB 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 IRB encourages use of our Events and Deviations Tables when doing summary reporting of events. The IRB 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 IRB immediately, even if they do not meet the criteria for individual reporting. The Memo re IND safety reporting can be shown to study sponsors to advise them of the UAMS IRB’s reporting expectations.