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About OnCore

OnCore (CTMS) is a suite of clinical and translational research modules consisting of software for research, patient registry and biospecimen management. OnCore is used by MCW to manage the life cycle of a clinical trial, including calendars, financial management, data monitoring, and reporting.

Why use OnCore at MCW?

OnCore is deployed enterprise-wide at the Medical College of Wisconsin as our primary Clinical Trial Management System (CTMS). OnCore offers comprehensive clinical trial life-cycle management, study participant and safety management, and electronic data capture and reporting functionality. OnCore represents the future of clinical trials at MCW with data integrations to applications like eBridge, Payments, and Epic systems.
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OnCore Financials is Live!

Froedtert & the Medical College of Wisconsin has committed to the implementation of OnCore Financials to standardize workflows and enhance the way clinical research is conducted across the organization. The MCW Office of Research is now requiring use of OnCore for all new studies that involve Froedtert Health Charges and/or MCW Professional Charges requiring Epic billing. For all other new studies, protocol entry into OnCore is strongly recommended per the OnCore Protocol Decision Tree (PDF).

Please refer to the OnCore Financials Toolbox (Intranet access required) for an overview of the Financial Lifecycle, training information, companion guides, and video demos to guide you through this new workflow.

Access the current list of OnCore Financials FAQ from the OnCore Financials Toolbox (Intranet access required).

CTMS Features

OnCore is a Clinical Trial Management System (CTMS) that supports day-to-day clinical trial activities including: study activation & life-cycle management, regulatory management, subject and visit tracking, comprehensive reporting, and electronic data capture.
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Biospecimen Management
Individual biospecimens can be tracked and monitored. Reporting capabilities exist at the individual sample or the biorepository level.
Coverage Analysis - Billing Compliance
  • A "Qualifying Clinical Trial Checklist" is built into OnCore, providing the ability to store and report information for determining if a protocol meets requirements for insurance reimbursements.
  • Billing designations are defined at the procedure or visit level. The rationale behind the designations are documented in OnCore.
  • The billing grid is based on the protocol calendar/schedule of events and provides documentation of billing decisions, including routine cost designations and why the study is designated as a qualifying clinical trial.
  • Centralized storage for all documents relevant to the coverage analysis process.

Data Monitoring
Data monitor queries are available for section and/or field level within an eCRF.
Electronic Data Capture and Data Management

Electronic Case Report Forms (eCRFs) may be created and associated with particular subject visits in support of investigator initiated trials. eCRF data entry is easy to navigate with its status-organized tabs. For analysis, form data can be exported in MS Excel and SAS formats.

Financial Management

Financial management includes:

  • budget creation and negotiation
  • standard of care versus research-related charge delineation
  • milestone-based payments
  • automated invoicing rules
  • invoice creation
  • payment reconciliation

The financial functionality also includes the potential for importing an enterprise charge master. 

Please refer to the Financials Toolbox InfoScope page (Intranet access required) for training and detailed information about using the Financials functionality in OnCore.

Protocol
Basic information associated with a particular protocol is recorded including protocol type, objectives, IRB and other committee reviews, research staff names and roles, and sponsor information.
Protocol and Subject Calendar Management

Calendars maintain study parameters including treatment administration, evaluations, and data collection schedules. Subject-specific calendars are automatically generated for subject visit tracking which drives the financial management functionality.

To Request an OnCore Calendar Purchase:

For calendar creation, please submit your request in iLab following the OnCore Calendar Requests in iLab Study Team Instructions (PDF). For inquiries, or if you are having trouble accessing iLab, contact iLab@mcw.edu.

Note: This service only for protocols using OnCore. Contact Help-OnCore for more information about calendars.

Reporting
Standard and custom reports are available. Additionally there are search functions that allow queries on dozens of fields. Together, these features help pull information together about clinical research trials with an ease not previously available. Powerful reporting features can serve as a data-driven means for crafting operational and staffing decisions.
Staff Effort Tracking
Staff may track their effort during the life of a protocol through integrated functionality. Staff Effort Tracking and Reporting can assist with effective budgeting and negotiating for clinical trials, establishing performance benchmarks and supporting requests for increased resources.
Study Information Portal

The Study Information Portal (SIP) supports a web-based interface for the general public to search and view protocol information in real-time and is tied directly to the OnCore database.

Subject

Subject information for a protocol is recorded including demographics, consents signed, and milestone dates for:

  • On study
  • On treatment
  • Off treatment
  • On follow-up
  • Off study
Subject Safety Management
Record AEs, SAEs, External Safety Reports and export to report to the IRB. Automatic safety notifications via email are configurable by protocol staff and/or role.
User Role Study and Institutional Base Security
Users are assigned specific access role(s) and assigned to specific institutions and management groups in their OnCore account. Each protocol is associated with specific management groups, institutions, and staff. Taken together, this provides users with the access they require to work in OnCore on their specific protocols.

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