- How to Prepare
- What do I need to do at go-live?
- What to expect at go-live
- More information on the Research Gateway IRB Transition
How to prepare
- Expect OnCore changes with the Research Gateway IRB implementation on July 1, 2026
- Plan for Clinical Trial Activation with OCTA
- A reminder on parallel submission and processing:
- For industry-sponsored studies, following budget negotiations studies pending UCSF IRB approval may delay clinical trial activation
- For non-industry studies, following PI approval of the CA, studies pending UCSF IRB approval may delay clinical trial activation
- A reminder on parallel submission and processing:
- Study Personnel Changes (instructions pending)
- Review the Study Personnel guide for actions needed to ensure your team members don't lose access to OnCore or APeX
- Key Study Personnel (KSP) will start in Research Gateway IRB and for studies linked to OnCore will automatically push to OnCore and flow to APeX and eReg using mapped roles
- Close-out Studies in OnCore and APeX
- Follow the Study Close-out Checklist and the Study Closure Quick Guide to update the protocol status in OnCore & Billing Status in APeX
- Use training resources - watch for announcements on training beginning in June 2026
What do I need to do at go live?
- Link IRB approved studies in Research Gateway IRB to the OnCore protocol (instructions pending)
Continue to use OCTA's Clinical Trial Activation Form
- OCTA's Service Now intake form will remain to capture study documents needed by OCTA for calendar build, coverage analysis, budgeting & CTA forwarding to ICD for review
What to Expect at Go-Live
Key changes to expect with OnCore when Research Gateway IRB launches on July 1, 2026
- OnCore Protocol Record Creation will be automated
- Study teams will enter data into IRB New Study application which will automatically populate OnCore Shell Record in one of two ways:
- IRB Pre-Submission – activity button to create OnCore record (expected to be used for initial Protocol Review and Monitoring Committee (PRMC) review and studies using Advarra eReg)
- IRB Initial Submission – auto-creates OnCore protocol record when study meets criteria
- Study teams will enter data into IRB New Study application which will automatically populate OnCore Shell Record in one of two ways:
- Key Study Personnel will integrate across systems
- Key Study Personnel (KSP) will start in Research Gateway IRB and for studies linked to OnCore will automatically push to OnCore and flow to APeX and eReg using mapped roles (instructions pending)
- Study Status alignment across systems
- Certain protocol status updates from Research Gateway IRB will integrate across the systems to OnCore and APeX
- Additional system Integration timepoints
- The Research Gateway IRB to OnCore integration will trigger with the following:
- OnCore Protocol Creation (create during pre-submission or at Initial submission)
- IRB Initial Submission
- Initial IRB Approval (letter sent)
- IRB Modification/Continuing Review Approval (letter sent)
- The Research Gateway IRB to OnCore integration will trigger with the following:
- IRB approval document integration
- Certain UCSF IRB approval documents from Research Gateway IRB will be linked within the OnCore IRB Review Record
- Department name changes
- Department names in OnCore will match Research Gateway IRB and Oracle/Peoplesoft
- The department listed on a protocol will be the Principal Investigator's primary HR department or the department receiving the award