What is OnCore? OnCore is the Clinical Research Management System (CRMS) developed by Forte Research Systems that will support clinical research activities at Duke. OnCore will provide 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 including human participant-based research. Submissions include new protocols, amendments, safety events, renewals, and closure thus supporting the needs of the clinical research community within DUHS.
All SON faculty, students and staff who submit studies in the eIRB, or enroll subjects on studies, must complete training to use these two systems. These new systems will change your workflow. Please refer to the New Systems = New Workflow section below to understand how this will impact you.
All team members, (PI’s, CRCs, Regulatory Coordinators, Financial Staff, and other research roles) must complete eLearning and/or instructor-led training to begin using OnCore.
Only users who complete their OnCore training by May 16 will be able to access OnCore when it goes live on May 21.
Users who complete training AFTER Wednesday, May 16 but BEFORE Go-Live on Monday, May 21 will receive access to OnCore the week of Go-Live (but not necessarily by Monday, May 21). Users who complete training AFTER Go-Live must use the Service Now process to request OnCore access.
Information about Go Live along with detailed OnCore Training information can be found on the DOCR OnCore Training Support page.
We encourage staff to complete their training modules in the LMS and start using the OnCore Training playground.
- Specific training tracks have been identified for several roles at Duke. Complete the role-specific OnCore online training via the Learning Management System (LMS) (See My Required Training Classes on the DOCR website for more information).
- Participants will need to self-enroll in classes when his or her functional role may include more than one role in OnCore. For example, a person with a title of Clinical Research Coordinator will be automatically enrolled in the Online CRC course in the LMS. If this person also performs traditional Regulatory Coordinator duties, he or she will need to self-enroll in the Regulatory Coordinator course as well.
- Participants will need to self-enroll in instructor-led classes in the LMS.
- Participants will need to pass an assessment of 80% or greater to be marked “complete” in the LMS and receive access to the OnCore system.
New Systems = New Workflow
With the implementation of iRIS and OnCore, the research workflow was designed to limit the change that you experience.
- New studies will start in iRIS (the new IRB submission system) much like they start in Click eIRB today.
- The interface between iRIS and OnCore will create the new protocol in OnCore to minimize duplicate data entry.
- 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.
- RDSP will occur in eGRC.
- 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.firstname.lastname@example.org.