果冻影院

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 (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@mcw.edu. 

Author:  Research Systems; 果冻影院 Office of Research

Applies to: 果冻影院 Faculty/Staff/Students involved in human research who utilize OnCore.

Version: 11/2/2020

Starting July 1, 2023:
鈥� Study teams of industry-sponsored trials need to budget for a CTMS* fee (currently $2065, which includes the initial calendar build).
*Please check the chargemaster in OnCore for the latest CTMS fee amount.
鈥� Cost will be billed via upon IRB approval (at the same time as the IRB & Florence fees).

Starting July 1, 2023, iLab and  (PDF) are updated to reflect the CTMS fees and initial calendar cost.

Note 1: This iLab service is only for protocols using OnCore. Contact OnCore@mcw.edu for more information about calendars.

Note 2: As of July 1, 2023, calendars for non-industry-sponsored trials will be covered by 果冻影院. For industry-sponsored trials, see 鈥淚s there a cost associated with using OnCore?鈥�.

Research staff are able to access the research chargemaster in OnCore once they have completed the OnCore Financials training.  Please refer to the  (intranet access required) for more information, or contact OnCore@mcw.edu with questions.

 

OnCore is 果冻影院'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. 

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

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

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. 

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.

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.  

Use your 果冻影院 network password to login to OnCore - the link can be accessed from InfoScope (secure network access required). You'll be locked out after three unsuccessful attempts. Contact Help-OnCore 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

• Primary Purpose/Protocol Type Definitions (PDF)
• Cancer Clinical Trial Definitions (PDF)
•  (PDF)

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

Use the key or combination of keys as an alternative way to enter information:

• Current day's date: t
• Number of days: n
• Current date plus n days: t+n:  (example: t+1 would enter tomorrow's date)
• Current date minus n days: t-n: (example: t-5 would enter the date 5 days ago)
• Current date plus n number of weeks: w+n
• Current date minus n number of weeks: w-n
• Current date plus n number of months: m+n
• Current date minus n number of months: m-n
• Current date plus n number of years: y+n
• Current date minus n number of years: y-n
• Beginning of the month (can be used alone or with the + or - n): mb
• End of the month (can be used alone or with the + or -n): me
• Beginning of the year (can be used alone or with the + or - n): yb
• End of the year (can be used alone or with + or - n): ye

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. 

No. REDCap will continue to be available. 

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

No. 果冻影院's version of OnCore is not 21 CFR Part 11 compliant. In the near future, the 果冻影院 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. 

Since NCI IRB reviews are NOT considered an 果冻影院 IRB review, you will still need to manually enter all review information into OnCore.

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.