Serious Adverse Events

This section will be helpful for CRAs who need to report a Serious Adverse Event for a subject. 

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 Subject "Epic MRN" hyperlink
4. Click the SAEs vertical tab
5. Create a new SAE record
   1. Click "New"
   2. Enter the following Required Fields into the "Subject SAE Update" block
      1. Event Date
         1. Date the event became reportable
      2. Event End Date
         1. Date the Serious event ended
      3. Reported Date
         1. Date the research team found out about the SAE. The research team includes all WUSM faculty and staff listed in myIRB
      4. PI Comments (Required for Oncology studies)
         1. This is a free-text field where the SAE reporting timeframe must be entered for Oncology studies
      5. Outcome
         1. Outcome is the status of the subject in regard to the SAE
      6. Adverse Event Details
         1. Details of the actual AE including CTCAE System, Term, Grade, and whether or not it is Unexpected
            
   3. Enter the following Required Fields in the "Tracking Details" block
      1. Notified Regulatory (date)
      2. Notified Sponsor (date)
      3. Team Reviewed (date)
   4. Click the "Submit" and "Close" button
6. Create a Follow-Up SAE record
   1. Find the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
   2. Click the "Create Follow-Up" button
   3. Enter updated information for the following Required Fields:
      1. Reported Date
      2. Outcome
      3. Notified Regulatory (date)
   4. Make any other updates to the original SAE
   5. Click the "Submit" and "Close" button
      
   6. In the "Supporting Documents" block, click Add
      1. Upload the PI Signed SAE Report
7. Complete SAE Record
   1. Find the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
   2. Click "Update"
   3. Enter the following required fields into the "Adverse Event Details" block
      1. Category
         1. The category option list is dependent upon the coding scheme associated with the protocol. For protocols using CTC V4, the category list corresponds to System Organ Class
      2. AE Detail
         1. The AE Detail option list is dependent upon the coding scheme associated with the protocol. For protocols using CTC V4, the category list corresponds to the System Organ Class
      3. Grade
         1. Grade is the severity of the AE. For protocols using CTC V4, grades 1 through 5 will display
      4. Unexpected
         1. An SAE is unexpected if its nature or severity is not consistent with information relevant source document(s) (e.g. investigator's brochure, consent, protocol)
   4. Click the "Add" button
   5. Click the "Submit" and "Close" button
   6. Navigate back to the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
   7. Click "Update"
   8. Ensure SAE information is Complete
   9. In the "Tracking Details" block, enter the Notified Sponsor Action Date
   10. In the "Supporting Documents" block, click add and upload the PI Signed SAE Report
   11. Click the "Complete and Lock" button
   12. The Regulatory Coordinator should complete the SAE Record according to the instructions on the "Updating Regulatory Reportable Event Information" Work Instruction

*Institutional required fields marked in red, bold font