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Research Systems

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Why use OnCore?

OnCore is currently being 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. 

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

New to OnCore?

This section of FAQ's are intended for new and prospective users. Please see the OnCore support pages for technical FAQ's and guides.

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What is OnCore?

OnCore is MCW's enterprise-wide Clinical Trial Management System (CTMS). OnCore is a comprehensive web-based CTMS that offers clinical trial lifecycle management, study participant and safety management, and electronic data capture and reporting through its core module. OnCore also allows for integrations with other enterprise-wide systems such EPIC and eBridge. 

Is OnCore currently being used at MCW?

Yes! OnCore was first introduced at MCW in 2012 when it was implemented in the adult Cancer Center and Department of Medicine/Cardiology. OnCore is now actively being used by several new divisions & departments and others are currently onboarding. For more information on how you can start using OnCore, contact OnCore support today!   

Do I have to use OnCore?

MCW does not currently require all departments to use OnCore to support their clinical research operations. However, OnCore represents the future of clinical trials at MCW with easy-to-use interfaces, powerful features and functionality while providing a central repository for subject & protocol data, and integrations to applications like eBridge, Payments, and Epic systems. 

Is there a cost associated with using OnCore?

Currently there is no cost to departments or investigators for using OnCore. 

What studies can be entered in OnCore?

As a Clinical Trials Management System, only research studies considered clinical trials involving human subjects and/or a tissue bank may be entered in OnCore.   Currently, any study with a cancer focus is required to be entered in OnCore, per MCW Cancer Center requirements. 

Can data be extracted from OnCore

Yes! Researchers can use standard reports that exist within OnCore, and they can use its search tool for ad-hoc reporting exported to excel or PDF. Searches can be saved for future use or QA purposes and rerun quickly.  Data gathered via electronic case report forms for Investigator Initiated studies can be exported in SAS or Excel formats.  Data may be extracted directly from the back-end database by the OnCore Developer. 

What does Enterprise OnCore mean?

Enterprise OnCore refers to the expanded installation of OnCore across all departments/disease areas. OnCore was originally developed for cancer centers in 2000, and as people recognized the value in using the system for other research, additional functions were added to better fit the needs of non-cancer trials.

Is MCW's version of OnCore 21 CFR Part 11 compliant?

No. MCW's version of OnCore is not 21 CFR Part 11 compliant. In the near future, the MCW Office of Research hopes to identify new solutions to help address the complexities involved with Investigator Initiated Trials, Investigational New Drug (IND), and Investigational Device Exemption (IDE) studies. 

What is the timeline for enterprise OnCore implementation?

OnCore implementation is ongoing!  As OnCore integrations with other system including eBridge and Epic improve, the benefits of OnCore will continue to increase. OnCore integration with Froedtert Health’s Epic Research Module is planned for the coming months, with OCRICC then completing their coverage analyses for clinical trials in the OnCore system. 

What fields are required to be entered into OnCore?

There are several fields that are required due to either system or institutional requirements.  Contact OnCore support for more details.

Are there any core functions of OnCore that are currently not available for expanded use?
 Yes. Currently we are unable to use the financial console to do sponsor invoicing.    
Will MCW discontinue the use of REDCap because of the implementation of OnCore?
No. REDCap will continue to be available.  

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.

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 complete the Protocol Release Request Form. Once received, the MCW Grants and Contracts Office will review and evaluate your request. Following approval, OnCore Support will submit your approved request to 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.