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Human Subjects

Reportable Events

Per the IU SOP for Research Involving Human Subjects on Reportable Events, investigators must communicate promptly reportable events (e.g. adverse events, protocol deviations, noncompliance, etc.) to the IRB within 5 business days. Events which are not promptly reportable are reported to the IRB at time of renewal. Please see the guidance on Reportable Events for more information on what should be reported

Reportable events are submitted to the IRB via the KC IRB “Notify IRB of a Reportable Event” action. Information regarding the event should be submitted via the Reportable Events Questionnaire located on the Questionnaire tab. For specific instructions, click here.

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