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Reporting

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.

Summary Event Reporting

Events that do not meet the criteria for individual reporting outlined above should be reported in summary at continuing review.

The IRB encourages use of our Events and Deviations Tables and Continuing Review Assessment Sheet when doing summary reporting of events. See Continuing Review Tools for more information.

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 Regarding Reporting Events and Deviations can be shown to study sponsors to advise them of the UAMS IRB’s reporting expectations.