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Serious Adverse Events

This section will be helpful for CRAs who need to report a Serious Adverse Event for a subject. The SAE needs to be entered in OnCore when the SAE is first reported to the protocol required recipient. Specifically:

• Pharmaceutical – per protocol timeline, almost always within 24 hours of finding out about the event
• NCI – per protocol timeline
• IIT – within 24 hours of finding out about the event

Step-by-step instructions for entering an SAE:

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
   To 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 Oncology Required Fields into the "Adverse Event Details" block
      1. Event Date
         1. Date the event became reportableserious
      2. Event End Date (Required for Oncology only)
         1. Date the Serious event endedstopped being serious
      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
         PI Comments (Required for Oncology only)
         1. This is a free-text field where the SAE reporting timeframe must be entered for Oncology studiesSAE is first reported to protocol required recipient (e.g. industry sponsor/drug manufacturer, Wash U, NCI, etc.)
      4. Outcome
         1. Outcome is of the status of the subject in regard to the SAE
         Adverse Event Details 
         1. event at time of SAE reporting (usually ongoing as of 24 hours)
      5. SAE Classifications (Required for Oncology only)
         1. Details of the actual AE including CTCAE System, Term, Grade, and whether or not it is Unexpected
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   4. Enter the following Oncology Required Fields in the "Tracking Details" block
      1. Notified Regulatory (date)
      2. Notified Sponsor (date)
      3. Team Reviewed (date)
   5. Click the "Submit" and "Close" button
6. If needed, 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. Event Date
      2. Reported Date
      3. Outcome
      4. Notified Regulatory (date) (Required for Oncology only)
   4. Make any other updates to the original SAE
   5. Click the "Submit" and "Close" button
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   6. For Oncology studies, in the "Supporting Documents" block, click Add
      1. Upload the PI Signed SAE Report
7. 1. 1. 1. Select choice from dropdown (e.g. Inpatient hospitalization, note: you can only select one)
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   2. You will need to get MD input to answer the following Oncology Required Fields in the Adverse Event Details box:
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      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)
      5.  DLT
      6. Action
      7. Source/Attribution Box: Investigation Tx field is mandatory, other fields preferred if available
   3. Enter the following Oncology Required Fields in the Tracking Details block:
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      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
   4. Click the "AddSubmit" and "Close" button
   5. Click the "Submit" and "Close" button
   6. Navigate back to Attach supporting documents
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      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".
8. If needed, 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 "UpdateCreate Follow-Up" button
   3. Ensure SAE information is Complete
   4. In the "Tracking Details" block, enter the Notified Sponsor Action Date
   5. In the "Supporting Documents" block, click add and upload the PI Signed SAE Report
   6. Click the "Complete and Lock" button
   7. The Regulatory Coordinator should complete the SAE Record according to the instructions on the "Updating Regulatory Reportable Event Information" Work InstructionEnter updated information for the following Required Fields into the "Subject SAE Update" block
      1. Event Date
      2. Event End Date (Required for Oncology only)
      3. Reported Date
      4. Outcome
   8. Make any other updates to the original SAE
   9. Click the "Submit" and "Close" button

*Required fields marked in red, bold font, required for all unless Oncology specifically called out

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.