INSTRUCTIONS

Complete this Noncompliance Form to determine if the non-compliance event is reportable to the KUMC IRB. After you complete the form, you will see instructions about whether the non-compliance event is reportable. 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 signed PDF in the electronic IRB system as an RNI.

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.

Regardless of reportability, the PI should sign the PDF form.

  1. If the noncompliance meets reportability requirements, the PI’s signature is required on the PDF form when submitting the RNI to the KUMC IRB.
  2. For noncompliance that does not meet reportability requirements to the IRB, the PI’s signature serves as source documentation to be maintained in study records.
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