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OnCore: Outside Research Group (ORG) Protocol Maintenance

Your study team is responsible for maintaining your SMPH oncology-related protocols.

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:

      IRB Entry Requirements

      1. Review, Submit, and Action Date: For all three review types, these three dates will be the date the review took place and is listed in the approval letter. 
      2. Committee: “HS-IRB”
      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: You only need to use this section for Reportable Events. This is what allows reportable events to appear on Protocol Summary Reports. The values for each Detail field are outlined below: 
        • 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

  • 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.

KeywordsORG DFD SOP accrual   Doc ID118651
OwnerIlsa G.GroupSMPH Research Informatics
Created2022-05-20 13:26:13Updated2023-11-08 20:12:25
SitesSMPH Research Informatics , SMPH Research Informatics TEST
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