OnCore Overview oncore-log-in-image

On this page you will find the following sections:


What is OnCore?

OnCore is a Clinical Trial Management System (CTMS) developed by Forte Research Systems, Inc.  It was developed in collaboration with leading research organizations and is widely adopted by academic medical centers, cancer centers and health care systems alike.  OnCore is currently being utilized by Indiana University in collaboration with our key research partners to record, manage and report on data associated with the operation of clinical trials.  The system is web-based and provides users secure access from any location.  The OnCore software system is comprised of three specific applications:  Clinical Research Management (CRM), Biospecimen Management (BSM) and Unified Registries Management (URM).  A list of the basic OnCore functionalities within the CRM is presented below:

OnCore Information


What Are the Benefits?

Increased Efficiency and Communication:  OnCore helps streamline and centralize clinical trial operations.  Having all protocol information available in one location and easily accessible by study personnel enables research teams to more efficiently manage trials with limited resources.  OnCore can assist with simplifying workflows and establishing standardized research management processes.  It also reduces the need for paper files and improves organization by allowing for the upload and storage of regulatory and protocol related documents.

Increased Patient Safety:  The Serious Adverse Events (SAE) and Data Safety Monitoring Committee (DSMC) management functionalities help improve reporting and communication regarding patient safety within and between protocols.  These areas can be used to facilitate reporting to regulatory bodies such as the IRB and FDA, or just track information for review by the study team.  An integration is also in place that links OnCore with Cerner PowerTrials.  This will allow patients to be flagged as research participants in the Cerner medical records system.

System Integration:  The goal of system integration is to reduce the effort needed to manage clinical trials.  Interfaces currently exist with Cerner to aid in patient safety and with INPC (Careweb) to aid in patient registration and data entry.  OnCore will also allow for future integration with other clinical systems like Epic and research systems such as Kuali Coeus.

Multilevel Custom Reporting and Research Portfolio Review:  OnCore increases the ability to run meaningful reports and track trends within and across multiple departments, divisions or specified management groups. It allows for quick and efficient reporting on protocol and subject information through the detailed search functions and provides a mechanism to track our clinical research portfolio at an organizational level.  Canned (pre-defined) reports are available and custom reports can be created to view information within and across protocols based on your individual need.

Financial Management:  OnCore allows for consistent financial tracking across clinical and research environments.  It provides a framework for building budgets and allows for real-time payment reconciliation. It allows you to distinguish between standard of care and research-related activities, and can also be used to generate a billing grid for Medicare coverage analysis.

Multicenter Study Management:  OnCore allows for users from external sites to enter their data directly into our secure, web-based system. User access can be limited to a specific institution and specific subjects while allowing for the coordinating center to manage all aspects of the trial.  This helps ensure data is protected while facilitating communication between the coordinating center and their affiliates.

Data Security:  Data entered into OnCore is stored behind University firewalls in a secured Oracle database that is maintained by UITS.  All patient information contained in OnCore is strictly confidential and is treated as Protected Health Information, as defined in 45 CFR 164.501.

Data Management:  OnCore has the ability to track and store patient information including clinical data.  Utilizing a centralized clinical trial management system for this purpose reduces unnecessary development of single purpose excel or access-based management tools that lack inter-connectivity to each other and the University systems.  Utilizing OnCore for clinical data entry also allows for easy monitoring by a data management team and the ability to export data to SAS (and other formats, such as excel and pdf) for biostatistical analysis.

Increased Regulatory Compliance:  Regulatory information can be tracked for each individual protocol.  This includes, but is not limited to, submissions and approvals from the IRB and other specified boards or committees, as well as general information on INDs and IDEs.  Features also exist for uploading documents and providing them to staff members in a version controlled environment.


Biospecimen Management

Coming Soon! For details, contact to the OnCore support team.


Unified Registries Management (URM)

Coming Soon! For details, contact to the OnCore support team.


Upgrades and Future Functionality

OnCore 14.1 MU1 is slated to be released in August 2016. Visit us again soon for updated information.

Area New Feature
Protocols Subjects When a Randomized Block or Stratified Block file is used, subjects who are assigned to an arm during Randomization can be manually registered to a second arm after they have an Off Arm date for their original randomized arm.
Subjects Reports The SAE Details Report and the Subject Deviation Report are now both customizable Jasper Reports. They are still run from the Subject Console; the customized version can be uploaded via Reports > Jasper Reports Administration.
Protocols The NCI’s CCOP program has been replaced by the NCI Community Oncology Research Program (NCORP).
In OnCore, the PC Console > CCOP Credits tab that was previously activated by the “CCOP” sponsor has been renamed, and is now controlled by the Sponsor Code and Description “NCORP”.
If you are using the NCORP Credits tab, you will need to update your CCOP sponsor to NCORP in 14.1 to maintain previous functionality.
Protocols A find-as-you-type box is now available in the PC Console > Institution tab when adding participating institutions.
Protocols The NCT Number can now be added when creating a new protocol in the PC Console.
ePRMS The NCT Number can now be added via the ePRMS Submission Console or Coordinator Console and is visible in all ePRMS Consoles.
Calendars Calendar Exchange You can now see visit tolerances, segment information, a summary of all the procedures and their schedules, and any visits that have been renamed. You can see this information when you export a calendar to Excel or when you preview a calendar that you are importing into your OnCore environment.
Coverage Analysis There are now three main billing designations: Bill to Sponsor, Bill to Patient/Insurance, and Not Billable. Supporting designations can be used to provide more detail when needed. The Billing Designation reference code is now the Supporting Designation reference code and is fully customizable.
Coverage Analysis The new Bulk Designation Set tool allows you to quickly set billing designations and supporting designations for multiple procedures at once. This tool will also set the billing designations and supporting designations for all visits and for all Charge Master events linked to those procedures.
This feature is available with the existing privilege Coverage Analysis – Coverage Analysis Update.
Financials Console The Verified? column now appears in the pop-up Visit Variations window when adding variations to an invoice.
Admin A new Query Tool is available under the Admin menu that will allow you (or your OnCore Product Support person) to run read-only queries within the application. This tool is designed to expedite troubleshooting and allow us to more quickly resolve issues.
You must opt-in during your 14.1 upgrade to install and use the new Query Tool. Access to the tool is controlled by a new privilege.
Admin
Effort Tracking
New Quick Filters and saved user preferences allow users to quickly enter and review their effort in OnCore’s Effort Tracking tool.
Admin Staff Improvements have been made to the Email Staff feature. Email addresses are now validated when entered in the Staff Console. Staff with valid email addresses can be included or excluded from each message. OnCore will not send the message to any staff with invalid or blank email addresses.
Admin A change was made to the logic used when the DISABLE_DUPLICATE_THERAPEUTIC_ENROLLMENT
config is set to Yes: Because subjects might consent to more than one therapeutic trial before actually choosing one and starting treatment, the check to prevent duplicate therapeutic studies is now done when an On Study date is entered for a subject, instead of when the subject is initially registered to a protocol.
Audits Typing a date into the Start Date field of a new audit now works! You can enter a date, use a date shortcut (such as w+2), or you can continue to use the Date Picker.
Protocol Search You can now include only Active Staff in your search. If you include assigned staff in your search results, the column header will indicate if you are looking at “Staff Name/Role” or “Active Staff Name/Role.”
Admin Task Lists You can now see where a global template is used by viewing a list of the Libraries in which the template is included.
Task Lists A new “Upcoming Tasks” widget shows the tasks that are assigned to you that do not have a Target Date, as well as tasks that are assigned to you that come after a “previous task” that is not yet complete.
The existing “Tasks” widget has been renamed “Active Tasks.”
Forms The Form Description now appears in the Form List and is searchable.
Forms Grid forms that used to show overlapping fields have been fixed.
Forms Fractional exponents (0.5 for a square root, or any other decimal value needed for BSA calculations, etc.) are now supported in the exp function. A new sqrt function is also available for square root calculations.
Admin Privileges Subjects My Console A new privilege allows you to control which users can update the Monitored, Submitted, and Locked dates of a subject visit in the Subject Console or My Console. This privilege is NOT automatically added to any Access Role during your upgrade.
RPE RPE 6.0.0 is now available and includes support for multi- destination RPE.
Reports Data Table 4 Several updates were made to the Data Table 4 report, the Data Table 4 eData report, and the Protocol Discrepancy Report: The previous logic excluded protocols where the Data Table 4 Report Type was set to “NA.” Now, the logic only includes protocols with a type of Interventional (INT), Observational (OBS), or Ancillary/Correlative (ANC/COR). This means that you can have more than one additional value besides the three standard ones, and only the three standard ones will be included on the report. We also made changes to the Data Table 4 report so that it includes the NCT Number, it identifies any sponsors listed as a “funding source,” it finds the earliest Open to Accrual date across all participating sites, and it uses the protocol Title instead of the Short Title field. In the eData report, the Title is truncated to 600 characters to match CCSG guidelines. The Data Table 4 Discrepancy report has also been updated to identify any protocols that are missing an NCT Number or that have a blank or invalid Primary Purpose.
Reports We have created new versions of the Enrollment Reports that match the latest guidelines. You can access them from the Custom Reports section of the Accrual Monitoring and Accrual Monitoring – Oncology Only report groups. The previous standard reports are still available.
Reports The Planned Visit Report now displays the earliest and latest possible dates for upcoming subject visits, based on the visit tolerances set in the calendar.
Biospecimens Barcodes Barcodes can now be required or not required on a protocol-by-protocol basis. They can be automatically generated or manually entered on a protocol-by-protocol basis.
Biospecimens Specimen Import In addition to importing new patients, cases, and specimens, you can now use the Specimen Import tool to update existing specimens in OnCore.