OnCore: Outside Research Group (ORG) Protocol Maintenance

Protocol Maintenance

When working on an oncology-related protocol, study staff must:

• Follow Oncology Data Field Definitions (DFDs)
  
  
• Follow Oncology Standard Operating Procedures (SOPs)
  
  
• Update the protocol regularly to include all Regulatory and Accrual entry
  • Per UWCCC DFDs
  • As required by NCI
    
    
• Ensure that all IRB Continuing Reviews, Change Reviews, and Reportable events in the study's ARROW record are recorded in the OnCore Reviews tab
  
  
  • Navigate to PC Console > Reviews > IRB tab in OnCore and click “Add.” The user should also have the ARROW record open with the “Follow-on Submissions” displayed. The Review Information form will then be displayed. A description of each field, along with the applicable information for each review type is outlined below:
    
    
    
    
    1. Review, Submit, and Action Date: Enter the date the review took place as listed in the approval letter in all three fields 
    2. Committee: “HS-IRB” or "MR-IRB" as indicated at the top of the IRB Approval Document
    3. Review Reason:
       • Change Review: "Change Review"
       • Continuing Review: "Continuing Review"
       • Reportable Event: "Reportable Event"
    4. Review Type:
       • Choose the appropriate descriptor from options including: Full, Expedited, Exempt, Facilitated
    5. Action: "Approved" or other action as appropriate
    6. Review No.: The Review Number assigned by the IRB (must be unique)
    7. Summary: Description or additional information you would like to capture
    8. Details: (Reportable Events only) 
       
       • Type: Reportable Event
       • Amendment No.: [Review No.]
       • Received and Version Date: Same date as the Review, Submit, and Action Date
       • Description: Copy and past the summary of the Reportable Event that you placed in the summary section
         
         
       • Note: Entering info in the Details section allows reportable events to appear on Protocol Summary Reports. 
• Submit or complete status change request
  
  
• Update the staff tab with any staffing changes regularly to ensure there are study contacts listed

Quality Assurance (QA) reports will be available to check for adherence to the oncology DFDs.