Reportable Events

Reporting events

Reportable events are submitted to the IRB via the Kuali Coeus IRB system. Information regarding the event should be submitted via the Reportable Events Questionnaire located on the questionnaire tab. For specific instructions, see the Quick guide: Submit a reportable event.

Here is guidance on reportable events along with which events should be promptly reported and which events should be reported with the study's next renewal.

When IU's Human Subjects Office receives a reportable event submission, staff will verify whether the event information meets prompt reporting criteria. If it does not require prompt reporting, HSO staff will confirm that the event should be reported at the next renewal and withdraw it from further separate review. If the item does require prompt reporting, HSO staff will prepare the information for review by the convened IRB.

Questions?

If you have a question regarding what category an event should be reported under, whether the event is promptly reportable, or if other IU institutional policies may apply, please contact the Human Subjects Office.

  • Phone: 317-274-8289
  • Email: irb@iu.edu