KC IRB Reportable Event

Quick Guide: Submit a Reportable Event

Applies to: All Reportable Events.

Learn How To Access Your Protocol

Report an Event

Steps to report an event

  1. 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.
  2. 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. Complete all questions that are presented in the Questionnaire.  Depending on your response to specific questions, additional questions may appear and other questions that don't apply may disappear.
  2. 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).”
  3. Protocol Questionnaires will appear under the 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.
  4. Navigate to the Notes & Attachments Tab

 

Upload supporting documentation

  1. Navigate to the Notes & Attachments tab.
  2. Click show on Protocol Attachments panel. 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.
  7. Navigate to the Protocol Actions tab.

Submit Report

Submit your Reportable Event

  1. Click show on Request an Action panel.
  2. Click show on the Submit for Review section.
  3. Click submit.

Contact the IU Human Research Protection Program

Human Subjects Research Questions:

Email: irb@iu.edu

Phone: (317) 274-8289

KC IRB Help:

Email: kcirb@iu.edu

Phone: (812) 856-4242