Quick Guide: Submit a Reportable Event
Report an Event
Steps to report an event
- 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.
- 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.
- 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.
- 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).”
- 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.
- Navigate to the Notes & Attachments Tab
Upload supporting documentation
- Navigate to the Notes & Attachments tab.
- Click show on Protocol Attachments panel. Select Attachment Type: Other from the drop-down list.
- Status will default to Complete.
- Enter a Description (e.g. Audit Response).
- To upload the document, click browse for the File Name and attach your document.
- Click add to upload the document.
- Navigate to the Protocol Actions tab.
Submit your Reportable Event
- Click show on Request an Action panel.
- Click show on the Submit for Review section.
- Click submit.