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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 serious
      2. Event End Date (Required for Oncology only)
         1. Date the event stopped being serious
      3. Reported Date
         1. Date SAE is first reported to protocol required recipient (e.g. industry sponsor/drug manufacturer, Wash U, NCI, etc.)
      4. Outcome
         1. Outcome of the event at time of SAE reporting (usually ongoing as of 24 hours)
      5. SAE Classifications (Required for Oncology only)
         1. Select choice from dropdown (e.g. Inpatient hospitalization, note: you can only select one)
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   3. You will need to get MD input to answer the following required fields in the Adverse Event Details box:
      1. Category, AE Detail, Grade/Severity, Unexpected, DLT, Action, Source/Attribution Box (Investigation Tx field is mandatory, other fields preferred if available)
   4. Enter the following Oncology Required Fields in the Tracking Details block:
      
      
      1. Notified FDA (date): For IITs, if applicable the date MedWatch form was submitted for the FDA
      2. Notified Regulatory (date): Same as Reported Date
      3. Team Reviewed (date): Date anyone on the research team (anyone in myIRB) found out about the SAE
   5. Click the "Submit" and "Close" button
   6. Attach supporting documents
      1. Document Type: SAE Form
      2. Upload: All completed forms and documents for the initial SAE report in PDF format
   7. Submit: To complete, click "Submit". Do not click "Complete and Lock".

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Common Terminology Criteria for Adverse Events (CTCAE):

•  Set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy.
• Each oncology protocol should specify which version of the CTCAE should be utilized.
• The CTCAE version can be updated/changed in the management tab of the PC console by the regulatory coordinator as long as no SAEs have been documented.