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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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.

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.

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.

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

• OnCore Field Definitions (PDF)
• Primary Purpose/Protocol Type Definitions (PDF)
• Cancer Clinical Trial Definitions (PDF)
• OnCore Protocol Naming Conventions  (PDF)

FIND OUT MORE

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

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. 

Studies that do not require patient consent including:

• Medical chart reviews
• Retrospective studies
• Registries
• Multiples of the same protocol in order to differentiate treatment/study phase
• Banking protocols (without specific approval)
• Educational/Outreach activities
• Emergency or Expanded access protocols (without specific approval)
• In-vitro studies that utilize non-identifying human tissue

OnCore is a software product developed by Forte Research Systems and is being deployed as the MCW 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. 

Yes! OnCore was first introduced at MCW in 2012 when it was implemented in the adult Cancer Center and Department of Medicine/Cardiology.  It is now being used by multiple divisions & department (link to list?) and several other departments are currently onboarding.  For more information on how to start using OnCore, contact OnCore support       

At this time, MCW does not require clinical research teams to use OnCore (other than studies with a cancer focus).  However, OnCore functionality is constantly improving, with connections to eBridge and Epic systems, and providing a central repository for subject & protocol data (versus multiple spreadsheets!).  Over 50% of clinical trials at MCW are now entered into OnCore!  It is our hope that departments will utilize OnCore to support their clinical research operations.

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

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. 

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.

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. 

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

• 2/8/18 - Addition of Clinical Research Coordinator at Subject Consented (PDF)
• 12/27/17 - Addition of OCRICC Assigned Staff to PC Console (PDF)
• 12/12/17 - STOP ENTERING Program Areas (PDF)
• 10/27/17 - Additions to Effort Tracking   (PDF)
• 9/26/17 - Addition of Clinical Research Coord - Secondary to Study Staff Roles (PDF)
• 6/15/17 - Undo Suspend vs Open Instructions  (PDF)
• 1/26/17 - Addition ABA - to Protocol Name for Abandoned Studies (PDF)
• 11/15/16 - Addition of Disease Site and/or Histology at Subject Consented (PDF)
• 8/20/16 - Initial IRB Review Tab - Updated Submit Date Definition (PDF)
• 8/3/16 - IND/IDE Tab Re-tool (PDF)
• 7/14/16 - Foundation Trials Sponsor Designation (PDF)
• 5/3/16 - PC Console>Accrual Information Section Updated Definitions (PDF)
• 3/2/16 - Task List Upgrade (PDF)
• 1/20/16 - Milestones Task List Launch - Non-CCCTO Protocols (PDF)
• 1/5/16 - Task List Launch - CCCTO Protocols Only (PDF)
• 1/4/16 - Task List Launch - CCCTO Protocols Only (PDF)
• 8/3/15 - Non CCCTO Management Group (PDF)
• 12/1/14 - Use of Display Protocol on SIP Check-box - Status Tab post Suspension (PDF)
• 10/23/14 - Removal of Regulatory Sign-off for Protocol Activation (PDF)
• 8/25/14 - NRG Management Group (PDF)
• 8/8/14 - Discontinue use of 'Includes Specimen Banking' button (PDF)
• 5/23/14 - Redefining Oncology Group (PDF)
• 5/19/14 - New Subject Registration Procedures - EPIC Integration (PDF)
• 4/14/14 - Effort Tracking Console-Update (PDF)
• 4/7/14 - Multi-Site Checklist Go-Live (PDF)
• 4/4/14 - Document Search and Study Status Reminders (PDF)
• 3/17/14 - Opening Studies to Accrual After Suspension (PDF)
• 11/15/13 - Reportable event IRB numbers (PDF)
• 5/3/13 - Notifications Go-Live (PDF)
• 4/25/13 - Required: Regulatory Checklist>Cooperative Group Activation Date (PDF)
• 4/15/13 - Pre-Screening>Not Eligible Additions (PDF)
• 3/25/13 - ECOG Management Group (PDF)
• 3/15/13 - RTOG Management Group (PDF)
• 1/31/13 - Co-Treating Physicians (PDF)
• 10/22/12 - Disease Site and/or Histology REQUIREMENT (PDF)
• 8/31/12 - Treating Physicians (PDF)

• 12/27/17 - Addition of OCRICC Assigned Staff to PC Console (PDF)
• 12/1/17 - Protocol Annotation Form (PDF)
• 1/26/17 - Addition ABA - to Protocol Name for Abandoned Studies (PDF)
• 8/20/16 - Initial IRB Review Tab - Updated Submit Date Definition (PDF)
• 8/3/16 - IND/IDE Tab Re-tool (PDF)
• 5/3/16 - PC Console>Accrual Information Section Updated Definitions (PDF)
• 12/1/14 - Use of Display Protocol on SIP Check-box - Status Tab post Suspension (PDF)
• 8/8/14 - Discontinue use of 'Includes Specimen Banking' button (PDF)
• 5/19/14 - New Subject Registration Procedures - EPIC Integration (PDF)
• 4/4/14 - Document Search and Study Status Reminders (PDF)
• 3/17/14 - Opening Studies to Accrual After Suspension (PDF)
• 11/5/13 - Reportable event IRB numbers (PDF)