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Human Subjects

Submit a Reportable Event

From the Kuali Enterprise Dashboard:

  1. Click KC IRB from the left-hand navigation bar.
  2. Click Submit a Reportable Event from the list of KC IRB Activities.
  3. Click perform action on the row displaying the protocol for which you need to submit a reportable event.
  4. From the Protocol Actions tab, under the Request an Action panel, click the create command button located under the Notify IRB of a Reportable Event section.
  5. The screen will navigate to the Questionnaire tab, where a Reportable Events Questionnaire will be displayed under the Submission Questionnaires section. This is a mandatory questionnaire that must be completed before you can submit your report.
    1. Depending on your response to specific questions, additional questions may appear and other questions that don’t apply may disappear.
  6. Click the update button at the end of the Questionnaire to save your changes. If all required questions have been answered, the Questionnaire heading will change from “(Incomplete)” to “(Complete).”
  7. Protocol Questionnaires will appear under Read-Only Questionnaire section below the Reportable Events Questionnaire. These are for reference only. You may not amend these Questionnaires at the time of a Reportable Events submission.
  8. To upload supporting documentation, click on the Notes & Attachments tab.
    1. Click show on Protocol Attachments panel.
    2. Select Attachment Type = Other from the drop-down list.
    3. Status will default to Complete.
    4. Enter a Description (e.g. Audit Response).
    5. To upload the document, click browse for the File Name and attach your document.
    6. Click add to upload the document.
  9. To submit the report, click on the Protocol Actions tab.
    1. Click show on Request an Action panel.
    2. Click show on the Submit for Review section.
    3. Click submit.