Serious Adverse Events
This section will be helpful for CRAs who need to report a Serious Adverse Event for a subject.
- Begin on Home Page > Subjects menu > CRA Console
- Select a protocol by entering the protocol number in the Select Protocol field
- Find Subject and click on Subject "Epic MRN" hyperlink
- Click the SAEs vertical tab
- Create a new SAE record
- Click "New"
- Enter the following Required Fields into the "Subject SAE Update" block
- Event Date
- Date the event became reportable
- Event End Date
- Date the Serious event ended
- Reported Date
- Date the research team found out about the SAE. The research team includes all WUSM faculty and staff listed in myIRB
- PI Comments (Required for Oncology studies)
- This is a free-text field where the SAE reporting timeframe must be entered for Oncology studies
- Outcome
- Outcome is the status of the subject in regard to the SAE
- Adverse Event Details
- Details of the actual AE including CTCAE System, Term, Grade, and whether or not it is Unexpected
- Details of the actual AE including CTCAE System, Term, Grade, and whether or not it is Unexpected
- Event Date
- Enter the following Required Fields in the "Tracking Details" block
- Notified Regulatory (date)
- Notified Sponsor (date)
- Team Reviewed (date)
- Click the "Submit" and "Close" button
- Create a Follow-Up SAE record
- Find the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
- Click the "Create Follow-Up" button
- Enter updated information for the following Required Fields:
- Reported Date
- Outcome
- Notified Regulatory (date)
- Make any other updates to the original SAE
- Click the "Submit" and "Close" button
- In the "Supporting Documents" block, click Add
- Upload the PI Signed SAE Report
- Complete SAE Record
- Find the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
- Click "Update"
- Enter the following required fields into the "Adverse Event Details" block
- Category
- 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
- AE Detail
- 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
- Grade
- Grade is the severity of the AE. For protocols using CTC V4, grades 1 through 5 will display
- Unexpected
- 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)
- Category
- Click the "Add" button
- Click the "Submit" and "Close" button
- Navigate back to the SAE record associated with the one you are updating and click on its "Event No. hyperlink"
- Click "Update"
- Ensure SAE information is Complete
- In the "Tracking Details" block, enter the Notified Sponsor Action Date
- In the "Supporting Documents" block, click add and upload the PI Signed SAE Report
- Click the "Complete and Lock" button
- 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