Clinical research changes: OnCore + iRIS go live 5/21

Sunday, May 6, 2018

Clinical Research at Duke is about to Change! OnCore and iRIS are going live on Monday May 21, 2018.

What is OnCore? 

OnCore is the Clinical Research Management System (CRMS) developed by Forte Research Systems that will support clinical research activities at Duke which will allow for enhanced clinical research study management, robust reporting, enrollment tracking, and accurate clinical research billing.

What is iRIS? 

iRIS is the electronic IRB (eIRB) developed by iMedRIS to be used for the submission, review, assessment, and approval of all research at Duke University to include human subject-based research. Submissions include new protocols, amendments, safety events, renewals, and closure thus supporting the needs of the clinical research community within DUHS.

Information about Go Live along with detailed OnCore Training information can be found on the DOCR OnCore Training Support page.

iRIS Support Page and Training information can be found on the DOCR iMedRIS Support Page

We encourage staff to complete their training modules in the LMS and start using the OnCore Training playground.

NOTE: 

  • Users who complete training BEFORE Wednesday, May 16thEOB will be added to OnCore in time for Go-Live on Monday, May 21st.
  • Users who complete training AFTER Wednesday, May 16th but BEFORE Go-Live on Monday, May 21st will receive access to OnCore the week of Go-Live (but not necessarily by Monday, May 21st).
  • Users who complete training AFTER Go-Live must use the Service Now process to request OnCore access.

Why the changes?

With the implementation of iRIS and OnCore, the research workflow was designed to limit the change that you and your staff experience.

  1. New studies will start in iRIS (the new IRB submission system) much like they start in Click eIRB today.
  2. The interface between iRIS and OnCore will create the new protocol in OnCore to minimize duplicate data entries.
  3. There will be a Sync to OnCore button that you must select to create the OnCore protocol.  Once your IRB submission is completed and sent for PI signoff, OnCore will be ready for your team to enter additional data and upload documents to facilitate the DOCR Study Start-Up process.
  4. RDSP will occur in eGRC.
  5. Once IRB approval occurs, the information will push into OnCore and the rest of the Institutional Approval process will happen in OnCore to allow the study to open to accrual.

If you have any questions, please reach out to DOCR help.