The University of North Carolina recently licensed OnCore, an enterprise clinical trial management system, with the aim of deploying the platform across the entire campus. Developed and supported by Advarra, OnCore has been used by the Lineberger Comprehensive Cancer Center for many years and will allow the University to greatly improve and standardize the way it manages clinical research.
With OnCore, Carolina will be able to reduce administrative burden, improve operational efficiencies, better understand UNC’s clinical research portfolio, and strategically pursue areas of growth. When the system is fully functional, it will manage up to 1,000 active protocols a year and nearly 2,000 users across the University’s entire research community.
The OnCore and ORIS teams are excited to announce an expansion of the current OnCore-IRBIS interface functionality. Starting January 17th, all approved Initial and Continuing IRB reviews (UNC and external Rely-Ons) for non-oncology studies will be sent automatically to OnCore, as long as the studies are properly linked between the two systems. This also includes consent information and documents!
What differences will I notice?
- For UNC IRB reviews, the review information (committee, dates, etc…) will continue to flow as normal. You will now see that consent information and the associated documents will also be attached to the review. Please confirm all information and documentation are correct for each review.
- For External IRB reviews, you will see that IRB review information, including consent information and the associated documentation, will flow automatically to OnCore once a review has been approved/acknowledged. This will look almost identical to the reviews that have been manually entered by the study teams, with the addition of the Review Number. Please confirm all information and documentation are correct for each review.
- For all reviews, selected documents from the approved review will automatically be uploaded to the Documents/Info tab of the PC Console.
What do I need to do?
- All non-oncology studies in OnCore as of the date listed above were automatically linked with this update. Moving forward, any new studies will need to be linked manually for these reviews to be transmitted from IRBIS. This tip sheet outlines how this link can be made during the initial IRBIS submission (Option 1, pages 1-3) or afterward (Option 2, pages 4-5).
- When a review has been approved/acknowledged, study teams should confirm that all information that has been sent to OnCore in the Reviews and Documents/Info tabs is correct. Please reach out to the OnCore support team if you see any errors.
Does this include any previous reviews?
- No, this will only populate for any Initial, Continuing, or Administrative reviews approved after the date listed above. If your study currently has expired review information in OnCore, you will need to update it manually until the next Continuing Review is approved. For example, if your study was approved by an external IRB on January 1, 2024, you will need to enter that information manually. When the next review occurs (for example, December 2024), this information will populate into OnCore automatically.
Please contact the OnCore Support Team with questions or concerns: OnCore@unc.edu.
- Advarra EDC
- OnCore Product Website
- Managing Clinical Research Administrative Data Policy
- Managing Clinical Research Administrative Data Standard
OnCore System Overview
Please see the video linked here for a brief OnCore demonstration from the 2020 UNC Symposium for Research Administrators.