OnCore

Overview

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.

Support

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]