What is OnCore?
OnCore is a clinical trial management system (CTMS) that enables the management of research, safety, regulatory, financial, biospecimen, and operational data in one location. At the University of California, San Francisco (UCSF) all clinical trials or research studies that bill through APeX are required to have a Coverage Analysis, and to enter and track clinical trial participants within OnCore and APeX. OnCore is the system in use at UCSF for Coverage Analysis. UCSF Campus Administrative Policy 400-25: OnCore Utilization and APeX Billing Review for Clinical Trials.
OnCore is managed and maintained by the UCSF OnCore Team in coordination with Academic Research Services (ARS), which works closely with study teams interested in incorporating OnCore into their workflows for more efficient clinical research operations and centralized data management. UCSF supports all of OnCore’s modules to provide a variety of data solutions and operations management tools for clinical research teams.
What is eReg?
More information on UCSF eReg coming in March 2026...
Advarra eReg is a 21 CFR Part 11 compliant electronic regulatory binder system that enables study teams to efficiently manage essential regulatory documentation. The system allows users to:
- Store and organize essential regulatory documents
- Track staff credentials and institutional regulatory documents across multiple protocols
- Manage Investigational New Drug (IND) applications, Standard Operating Procedures (SOPs), and subject-related documents
- Facilitate remote monitoring by sponsors and auditors through configurable review sessions
- Route documents for compliant electronic signature and automatically notify users when their signature is required
Who do I contact for help?
The Office of Clinical Trial Activation (OCTA) in coordination with Academic Research Services (ARS) is committed to assisting study teams; here are options for getting help with questions you may have.
- OnCore and eReg Helpdesk: [email protected]
- APeX Research Support Team - APeX Research/415-514-APEX (2739)
- Visit OnCore Access and Training for a list of available courses
- Review OnCore Resources for quick guides
Participant/Subject Enrollment in OnCore
Starting May 7, 2018, UCSF began enrolling and tracking study subject visits in a single clinical trials management system, OnCore, for all clinical trials that bill through APeX. This created the following changes in study team workflows:
1. All study Participants/Subjects need to be Enrolled in OnCore; study teams are no longer able to enroll subjects in APeX. To Enroll a Participant/Subject in OnCore:
- Register Participant/Subject to the Protocol
- Give active status of Consented
- Update Participant/Subject's On Study, On Arm, and On Treatment dates
- Track/Occur Participant/Subjects Calendar dates
Click here for a summary of the required fields to enroll a subject in OnCore.
2. It is very important to link Research Patient encounter(s) in APeX; tip sheets to help with this process are available.
3. Now you can:
- Place orders in APeX
- Track Study Visits in OnCore