INSTRUCTIONS

Complete this Adverse Event Form to determine if the adverse event is reportable to the KUMC IRB. By pressing “Submit” at the end of the form, a PDF will be generated for your records. If the event is reportable, please upload the PDF form in the electronic IRB system, along with any supporting documentation as an RNI.

  • For internal events, include notes from the EMR and reports to the sponsor (redacted to remove identifiers)
  • For external events, include the sponsor’s determination that demonstrates reportability.

NOTE: If you are unable to complete the form in its entirety, the form can be saved and retrieved later by pressing the “Save and Return” button. A form code will generate and must be saved to access the form later.

More information about adverse event reporting can be found on the KUMC IRB website and in section 5.3 in the IRB SOP 05.0

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