Updating Regulatory Reportable Event Information

This section applies to Regulatory Coordinators who are completing an SAE record or a Deviation Record. CRAs should not be completing these records. 

To Update a Serious Adverse Event Record

1. Begin on Home Page > Subjects menu >CRA Console
2. Select a protocol by entering the protocol number in the Select Protocol field
3. Find Subject and click on the subject "Epic MRN" hyperlink
4. Click the SAEs vertical tab
5. Find the SAE Record associated with the one you are updating and click on its "Event No. hyperlink"
6. Click "Undo Complete"
7. Click "Update"
8. Update the following Required Field in the "Subject SAE Update" block:
   1. Report to IRB?
      1. This indicates when the deviation was/will be reported to the IRB
      2. Immediately - should be selected to SAEs and Deviations meeting IRB reporting guidelines
      3. Next Continuing Review - should be selected for SAEs and Deviations NOT meeting IRB reporting guidelines
      
9. If the "Report to IRB?" field is set to Immediately, the below field in the "Tracking Details" block is also required:
   
   1. Notified IRB Action Date
      1. This indicates the date the SAE was reported to the IRB
      
10. Click the "Complete and Lock" button
11. Click "Close"

To Update a Subject Deviation Record

1. Begin on Home Page > Subjects menu >CRA Console
2. Select a protocol by entering the protocol number in the Select Protocol field
3. Find Subject and click on the subject "Epic MRN" hyperlink
4. Click the Deviations vertical tab
5. In "Subject Deviation Details" block, click the blue date link of the deviation you are updating
6. Click "Update"
7. Update the following Required Field in the "Subject Deviation Update" block:
   1. Report to IRB?
8. If the "Report to IRB?" field is set to Immediately, the below field in the "Subject Deviation Update" block is also required:
   1. Date Reported to IRB
      1. This indicates the date the deviation was reported to the IRB
9. Click the "Submit" button
10. Click the "Close" button

To Update a Protocol Deviation Record

1. Begin on the Home page > Protocols menu > PC Console
2. Select a protocol by entering the protocol number in the Select Protocol field
3. Click the Deviations vertical tab
4. In "Protocol Deviations Overview" block, click the blue "Date Discovered" link of the deviation you are updating
5. Click "Update"
   
6. Update the following Required Field in the "Protocol Deviation Update" block:
   1. Report to IRB?
7. If the Report to IRB? field is set to Immediately, the below field in the "Protocol Deviation Update" block is also required:
   1. Date Reported to IRB
8. Click "Submit"
9. Click "Close"

*Institutional required fields marked in red, bold font