OnCore and eReg

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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?

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

Part 11 Compliance Info

UCSF's Non-Repudiation Letter

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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.

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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

OnCore Modules

 

Clinical Research Management (CRM)

The OnCore CRM module supports management of protocols, subjects, and study financials in one place:

 Subject tracking and clinical data collection:

  • Subject enrollment and visit tracking using OnCore calendar functionality
  • Automatic retrieval of demographics data for UCSF patients (via APeX interface)
  • Clinical data capture using standard forms (CRFs) from the OnCore library or study-specific custom forms
  • Monitoring functionality to query and validate form data
  • Data retrieval through direct export or custom reporting

Study financial management:

  • Communication tool between research coordinators and post-award analysts
  • Coverage analysis document and budget development tools
  • Study milestones tracking, sponsor invoicing, and payment reconciliation

Research program oversight:

  • Staff effort tracking for resource allocation and program management
  • Checklists to track study start-up activities and streamline processes

  • Notification functionality to alert research staff and collaborators about subject milestones, safety monitoring, or regulatory expirations

     

Biospecimen Management (BSM)

The OnCore BSM module enables management of real-time specimen acquisition, tracking, and data entry for specimen research and correlative studies:

  • Storage location and inventory management
  • Management of specimen requests and distribution
  • Barcoding and label printing using BarTender (OnCore compatible third-party tool)
  • Conducted as a peer-led training with sign-off documentation. Request via [email protected]

Registries Management (RM)

The OnCore RM module enables management of clinical research data sets configured around an event (e.g., biopsy or surgery), condition, diagnosis, or patient characteristics:

  • Ability to create hierarchical registries for data capture at the case, patient, or event level
  • Unified forms engine for consistent data collection across URM and other OnCore modules
  • Self-serve report building functionality for data export and analysis
  • Conducted on an as-needed basis. Request via [email protected]

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