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Why use OnCore?

OnCore is deployed enterprise-wide at MCW 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. 

OnCore Financials and Coverage Analysis

In the Spring of 2023, OnCore functionality will expand to include coverage analysis in OnCore by OCRICC and managing study budgets with the OnCore Financials screens.

To start preparing your teams for this added functionality, please review the Financials FAQ and F&MCW OnCore Decision Tree (PDF) for what studies should be in OnCore and which studies require calendars. Use the Quick Reference: Advarra OnCore Financials Training (PDF) to learn what training is available (many free of charge) from Advarra University. 

 

What does OnCore mean to me?

We asked current MCW OnCore users "What does OnCore mean to you?" Here is what they had to say. 

Coveo User Context

"OnCore has been an integral part of the creation and ongoing growth of our Cancer Clinical Trials Office offering both protocol and patient management on a single platform. The availability of tools in the system and reporting metrics have given us an understanding of the true cost of research support and an ability to provide more accurate forecasting. The assessment of activation timelines and staff workloads have assisted in a metrics driven justification for changes in staffing. The efficiency and accuracy of OnCore reporting is essential to the continuing success and management of our office.”

Betty Oleson

CTO Administrative Director

Coveo User Context

“OnCore is my go-to daily resource for managing studies across various disease groups and treatment disciplines. The centralized use of subject management, protocol status updates, calendar viewing, and eCRF data collection that OnCore provides are critical to the flow of clinical research at our site. OnCore allows us to stay current with technological developments as we continue to advance healthcare through research.”

COLLETTE BIEN, BA, CCRP 

Clinical Research Coordinator 

Coveo User Context

“As a staff educator, I use OnCore during my training constantly. Where do I even begin? Having OnCore means that I have all the info I need in one place. I can identify quickly the coordinator and PI; the accrual of the study including all the current patient statuses and can pull documents (like a protocol or consent) quickly for any reason. I can teach staff about workflows using the calendars as a guide.  It has replaced tons of other tracking mechanisms we used to do in programs like excel. It’s the best.”

Becca Selle, BS, CCRP

Education & QA Manager

Coveo User Context

“As the Chief Administrator for Research Operations, having OnCore as our clinical trials management system is part of an integrated research infrastructure to enhance and support the way research is conducted at MCW. It means that our Principal Investigators and clinical trials coordinators have a system which can help them streamline and navigate the complexities of clinical trials and the subjects on trials. This system also provides the institution the capability to collect data on our trial activity to monitor research metrics that drive decision making and resource management.” 

Lisa Henk

Chief Administrator for Research Operations

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.

The OnCore Financials Project is currently underway with a go-live date of Spring 2023. To learn more about the OnCore Financials Console or review how it works while time allows before End User training in Spring 2023, review the Quick Reference: Advarra OnCore Financials Training (PDF) for training options for each of the components. 

 

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 oncore@mcw.edu for more information about calendars.

Request Calendar

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.