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:
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.
Change Review: "Change Review"
Continuing Review: "Continuing Review"
Reportable Event: "Reportable Event"
Choose the appropriate descriptor from options including: Full, Expedited, Exempt, Facilitated
Action: "Approved" or other action as appropriate
Review No.: The Review Number assigned by the IRB (must be unique)
Summary: Description or additional information you would like to capture
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.