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OnCore Support and Frequently Asked Questions

OnCore Support provides documentation and guidance for using the system and entering clinical trial information.

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If you do not find the answers you are looking for here, please contact OnCore Support with questions.

OnCore SOPs

 
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OnCore Data Entry & Quality Assurance Guidelines

Author:  Research Systems; MCW Office of Research

Applies to: MCW Faculty/Staff/Students involved in human research who utilize OnCore.

Version: 11/2/2020

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OnCore FAQ

 
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Protocol Entry in OnCore Decision Tree

As a Clinical Trials Management System, most research studies involving human subjects can be entered in OnCore, including treatment, observational, basic science, device feasibility, screening, prevention and other trials. 

View the F&MCW OnCore Decision Tree (PDF) to help you determine if your study should be in OnCore.  

If you have questions on whether your study qualifies for entry into OnCore, please contact OnCore Support

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. 

As a Clinical Trials Management System, any research studies involving human subjects can be entered in OnCore, including treatment, observational, basic science, device feasibility, screening, prevention and other trials. 

 
Do I have to use OnCore?

At this time, MCW does not require clinical research teams to use OnCore (other than studies with a cancer focus). View the F&MCW OnCore Decision Tree (PDF) to help you determine if your study should be in OnCore. 

Following the implementation of Financials in Spring 2023, the use of OnCore will become standard practice. 

 
Is there a cost associated with using OnCore?
Currently, aside from fees associated with purchasing/setup of calendars, there is no cost to departments or investigators for using OnCore CTMS.
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. 
Calendar Request

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 Support for more information about calendars.

Entering and Editing Data

Many pages in the OnCore application display in view-only or update mode. In view-only mode, you can view data but you cannot make modifications to it. In update mode, the fields on the page become editable.

Both view-only and update modes are controlled by assigned roles. One role allows read-only access to a screen, and an additional role must be assigned to allow the user to update data on that screen. The access you receive will be determined by the work you are assigned to complete in your position.

If you have the role to update information on a screen in OnCore, an update button will appear in the lower-right corner of the page. In update mode, you can edit data in text fields, select different values from the drop-down menus, and select or deselect options.

Once you are in update   mode, several additional buttons appear at the bottom of the page. These buttons typically include the Submit, Clear, and Close options.

Submit: Saves the data entered on the page; the page remains in update mode.
Clear: Restores all fields to the most recently saved values; it does NOT erase all data on the page unless this is the first data you input.
Close: Returns the page to read-only mode; any data not saved by using the Submit button will be discarded.

Logging into OnCore

Use your MCW network password to login to OnCore - the link can be accesses from InfoScope (secure network access required). You'll be locked out after three unsuccessful attempts. Contact the Help Desk OnCore@mcw.edu if this happens.

Tips

  • Only one session (browser window or browser tab) of OnCore should be open at a time on a single system. Multiple sessions of OnCore could result in duplicate data and application problems.
  • Avoid using the browser's back button. Use OnCore's buttons, tabs, and menus to navigate within the program. Using the browser toolbar to navigate may cause unexpected results, such as unsaved data or web page errors.
  • Embedded into each OnCore console screen is a ? icon that links to the Learning Portal. It offers instructions and references to the screen from which you selected the icon, as well as both recorded and live webinars on a variety of OnCore topics.
  • Disable pop-up blockers for OnCore.
    OnCore uses many pop-up windows that allow you to make selections and enter data. Your browser pop-up setting must be set to allow pop-ups during each session.
Menus and Menu Items

Many of the features of OnCore can be viewed in the PC Console. To open the PC Console:

  1. Hover the mouse cursor over the Protocols menu. A list of menu items appear.
  2. Select the PC Console menu item.
  3. In OnCore, the action of moving through several options to reach a desired location is called navigation.
  4. Navigation through several areas of a function is often described in a path, such as:

    Navigate to Protocols > PC Console
Research Chargemaster - Find pricing for Froedtert Health services

Use the Research Chargemaster. This tool is to be used by researchers and their teams to obtain pricing requests for time-sensitive preliminary/estimate budgets, grant applications and study financial feasibility reviews for Froedtert Health entities.

Note: With the implementation of Financials in Spring 2023, the Research Chargemaster will be integrated into OnCore and will be accessible to research teams from within OnCore.

FIND OUT MORE

Using Date Widgets and Keyboard Shortcuts

Date Widgets
Fields that display the date icon  to the right of a date field use date widgets (calendar). Clicking on the date icon launches the date widget, allowing the selection of a date from a calendar. The calendar allows for historical and future days/month/years.

Date Formats
OnCore accepts dates in a number of formats, including 1 or 2 digit months and days, and 2 or 4 digit years. OnCore converts all entries into the MM/DD/YYYY format. If you enter 2 digit months and days, you can omit the slashes. Any of the following will work:

  • 12/2/09 will become 12/02/2009
  • 4/6/88 will become 04/06/1988
  • 09/01/1955 displays as is
  • 080810 will become 08/08/2010

Keyboard Shortcuts

Shortcut Resulting Entry

t

n

Current day's date

Number of days

t+n

t-n

Current date plusndays

Current date minusndays

examples: t+1(tomorrow) or t-5 (5 days ago)

w+n

w-n

Current date plusnnumber of weeks

Current date minusnnumber of weeks

m+n

m-n

Current date plusnnumber of months

Current date minusnnumber of months

y+n

y-n

Current date plusnnumber of years

Current date minusnnumber of years

mb


me

Beginning of the month
(can be used alone or with the + or -n)

End of the month
(can be used alone or with the + or -n)

yb

ye

Beginning of the year
(can be used alone or with the + or -n)

End of the year
(can be used alone or with the + or -n)

 

Using Vertical and Horizontal Menu Tabs

OnCore uses vertical and horizontal menu tabs to navigate a protocol.

The left side of the OnCore screen displays a column of vertical tabs. Each vertical menu tab allows you to view information specific to the area described in the tab name.

When a vertical column of tabs display, there will often be corresponding horizontal menu tabs. 

Will MCW discontinue the use of REDCap because of the implementation of OnCore?
No. REDCap will continue to be available. 
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.
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. 
Will NCI IRB review data be pushed to OnCore from eBridge?
Since NCI IRB reviews are NOT considered an MCW IRB review, you will still need to manually enter all review information into OnCore.
Should I enter an expiration date in the field for AMEs or REs?
No, you should NOT enter an expiration date in the field for AMEs or REs. The reason for that is because in eBridge there are no expiration dates associated with those two types of reviews and therefore should remain blank.

OnCore Financials

The OnCore Financials FAQ will be updated with questions and responses as new information is available. Monitor the OnCore Financials InfoScope site for updates.
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How do study teams know whether a study belongs in OnCore or if an OnCore calendar is required with the new OnCore Financials process?

The F&MCW OnCore Decision Tree (PDF) provides guidance on the types of studies that should be entered in OnCore and when an OnCore calendar is required. If teams have further questions, they can email OnCore Support.

Which projects will be in-scope/out-of-scope for OnCore Financials implementation?
Please refer to the F&MCW OnCore Decision Tree (PDF). All new studies utilizing FH Epic billing must go into OnCore with calendars and use Financials. For legacy studies, the final criteria for projects being in-scope or out-of-scope has not been decided. This decision will evolve as the financials process development occurs. Current thinking supports inclusion of all studies which have research billing that is managed in FH EPIC by OCRICC and/or CPS. Further considerations include the expected duration of the trial and the need for study teams to enter all legacy data (i.e., calendaring visits, coverage analysis, budget details, previous invoicing). Ultimately, the real benefit will need to be measured against the effort of manually entering legacy data. 
What is the timeline for completion of the two phases of the OnCore Financials project?

The OnCore Financials project started June 2022 and is projected to continue through calendar year 2023. Phase 1 completion and end user training is anticipated in Spring 2023. Refer to table below for the activities during this timeline. 

Are training resources available if I want to learn more about the OnCore Financials Console or review how it works before End User training in spring 2023?
Yes! The Quick Reference: Advarra OnCore Financials Training (PDF) reviews training options for each of the components of OnCore Financials. 
Will the need to email signed consent forms to OCRICC cease once OnCore Financials is in place? 

At this time, the need to send signed consent forms to OCRICC to be added to the EMR remains the same. The signed consent also represents the patient authorization of release of protected health information for research, which is required to be documented in their legal health record. Consent documents (signed or unsigned) are not stored in OnCore. Consent documents may be stored and certified as original through the electronic certification processes within Florence eBinders.  

Will costs for an OnCore calendar build differ based on the project funding source? 

The cost of the OnCore calendar is not dependent on the type of funding source. The cost is a flat fee, which includes MCW F&A, and the effort of the research staff to review the calendar prior to study activation.  

Advarra uses their fully owned subsidiary company to provide services for clinical trials including calendar builds.  These services are provided by their Business Operations Services (BOS) team.  The current calendar purchase fee is $246.05, will be assessed the appropriate MCW indirect rate (based on funding source). This fee may change as the contract between Advarra and MCW is renegotiated in the future. 

Under which circumstances will someone from the department/study teams need to build a calendar or calendar pieces?
Please refer to the F&MCW OnCore Decision Tree (PDF) to determine when a calendar is required. Research staff are not responsible for completing the initial calendar builds for each study. Building the calendar can be complicated, and the accuracy of the calendar will impact multiple features in OnCore Financials; Coverage Analysis, Budgeting, etc. MCW uses the Advarra BOS team for initial build of most calendars for a nominal charge and the department/study teams will be responsible for calendar approval prior to release. 

Individuals responsible for study budget development may need to make/request adjustments to the OnCore calendar to accommodate study budget needs. 

 

Will Children’s Wisconsin (CW) services be affected by OnCore Financials? 
Use of OnCore by pediatric study teams is welcomed, encouraged, and available at no cost to any MCW investigator/study staff.  Many of OnCore’s current functions would directly benefit the pediatric study teams, including integration with eBridge, Payments and Florence eBinders. However, it is important to note that CW EPIC does not currently interface with OnCore.  Consideration for expansion of Oncore Financials workflows will be discussed with CW in the future; but would be limited without the OnCore – Epic interfaces.   

Study teams with protocols that involve both minors and adults and use Froedtert Health (FH) services including FH Epic and enrolling adult subjects, will be transitioned to the new standardized financials beginning in Spring 2023. Pediatric study teams with research involving adult subjects with FH services are encouraged to begin using OnCore to track these study subjects as soon as possible to eliminate the need to catch up later.   
Will research teams be able to view status updates on OCRICC invoices through OnCore? For example, will they be able to log in a see that payment for an OCRICC invoice was fully processed?  Will invoices be processed directly through OnCore vs. an outside system like Oracle?
No, invoices from “service areas”, like OCRICC, are not part of the automation plan.  Expected study costs built into the budget will produce Study Payables in OnCore allowing study teams to reconcile invoices they receive but will not trigger payments.   

In Phase 2 of the project, Summer of 2023, Sponsor Invoices produced by the study teams will be interfaced to Oracle to create receivables to help facilitate the sponsor payment reconciliation process easier.   

ORACLE will remain the source of truth for account transactions and summaries at the end of the OnCore Financials project. 
Will subject stipends be able to be issued directly through OnCore vs. needing to log in separately to the Study Payments system to issue these?
No, subject stipends will continue to be processed through Advarra Payments. The Payments system is integrated with OnCore and does receive some subject data from OnCore; however, management of the subject stipend process will remain a function of Advarra Payments.  
What will change with Epic and charge entry in relation to OnCore Financials implementation?  How will the systems know that a visit marked as “occurred” in OnCore matches a specific visit encounter in Epic?  How will these be linked?

Study coordinators will be expected to link the visits and procedures to the study in FH Epic as they are required today. This will remain an important step after the OnCore Financials project is complete. Specific data entered in your OnCore protocol, coverage analysis, and subject statuses support this process. Phase 1 will introduce a new process to notify OCRICC and CPS of visit variations through OnCore.  

In the second phase of the project, a new interface, the CRPC, will enable coordinators to generate patient timelines (study billing grids) in Epic which will identify which visits match the study timeline for easier identification and linking.  The best description of how the CRPC interface works with Epic is by association; meaning the linked visits are directed to the research billing buckets by falling within the research billing grid.   

 

How does the CRPC interface affect subject billing?

The CRPC interface will communicate details regarding procedures, visits, coverage analysis, and Q0 and Q1 modifiers from OnCore to the Epic Billing Protocols. These communications will only cover study charges that are included as a billing line item in Epic (service, supply, procedure, or encounter). The details received in Epic will pre-bucket study related charges to the appropriate “Bill to Study” or “Bill to Insurance” bucket, with Q0 and Q1 modifiers, for OCRICC and MCW billing teams to review and release appropriately to insurance or back to study teams for payment.  The CRPC does not directly deal with per subject billing. 

This grid allows OCRICC and CPS (MCW) to appropriately route each charge in Epic: 

 


After the CRPC interface is active, will Epic bill the study account directly?
Unlikely. OCRICC needs to do manual review of invoices prior to sending to ensure accuracy and remove ancillary/supply charges from bundled services. CPS does not manage invoicing to study accounts.
Can OnCore calendars and OnCore Financials be used for all clinical trials, regardless of sponsor type?

Yes, OnCore and all its functions should be used to track study and subject study-related activities, especially those involving Froedtert resources, regardless of the funding source.  OnCore allows for efficient and standardized tracking and reporting of financials tied to study activities and subjects in a single system, and by the end of Phase 2 of Financials implementation will allow for receipts tracking through the ORACLE interface.  

 

The Coverage Analysis Console talks about a QCT Checklist. What is a Qualifying Clinical Trial (QCT)?
Click the links for details and background information about what meets the criteria for a qualifying clinical trial. The National Coverage Decision (NCD) (PDF) offers specific guidance concerning Clinical Trials Billing. Under the National Coverage Decision (NCD), Medicare will cover those routine costs of qualifying clinical trials and the costs of items and services that are reasonable and necessary* to diagnose and treat complications arising from participation in all clinical trials (Centers for Medicare and Medicaid Publication 100-3, Ch 1, Part 4, Section 310.1) (PDF). 
What are Q0 & Q1 billing modifiers?

The Q0 & Q1 modifiers are included on outpatient provider (professional billing) claims for items/services provided in Medicare qualified clinical trials/studies. 

Use Q0 to designate the item under investigation in the trial/study. 

Use Q1 to identify routine services provided in the trial/study. 

 

Routine clinical services are provider-based services, procedures, items that would be covered by Medicare if the subject was not in the study and are standardly used for clinical care of a patient with the same diagnosis. 

Investigational services are provider-based services, procedures, items that being evaluated as effective or safe in the trial/study.   

 Examples of Routine Services include: 

 
 
 
 
 
 

What are Routine Costs Provided to Qualifying Clinical Trials?


 
 

Routine Costs

 
 

Excluded from Routine Costs


 
 

Items or services required solely for the provision of the investigational item or service (e.g., infusion)

 
 

Items or services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient or not used to monitor the effects of the item or service (e.g., plasma biomarkers)


 
 

Items or services typically provided absent a clinical trial

 
 

An investigational item or service itself if used in a non-FDA approved way


 
 

Clinically appropriate monitoring of the effects of the item or service (e.g., monitoring side effects or complications)

 
 

Items or services customarily provided by the sponsors free of charge

 

Prevention of complications

 
 

Items or services provided solely to determine trial eligibility


 
 

Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service (e.g., hydration fluids as part of chemotherapy treatment)

 
 

Treatment of healthy volunteers unless used as controls

 
 
 
 

 
 

Cosmetic surgery, some prosthetics, herbal remedies, relaxation therapies, etc.


What other OnCore Financials questions do you have?

OnCore Communication Memos

Documentation and memos relating to OnCore implementation, policies, and upgrades. 
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Cancer Related Communication Memos