OnCore Overview oncore-log-in-image

On this page you will find the following sections:

What is OnCore?

OnCore is a Clinical Research Management System (CRMS) developed by Forte Research Systems and developed in collaboration with leading research organizations. It is widely adopted by academic medical centers, cancer centers and health care systems alike. OnCore is currently being used by Indiana University in collaboration with our key research partners to record, manage and report on data associated with the operation of clinical research. The system is web-based and provides users secure access from any location. The OnCore software system is comprised of 3 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 study operations. Having all protocol information available in 1 location and easily accessible by study personnel enables research teams to more efficiently manage studies with limited resources. OnCore can help simplify workflows and establish 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 studies. 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, providing a framework for building budgets and allowing for real-time payment reconciliation. It allows you to distinguish between standard of care and research-related activities and can also 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 study. 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.  Using a centralized clinical study management system reduces the need for single purpose Excel or access-based management tools that lack interconnectivity to each other and the University systems. Using 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

A new version of OnCore 15.0 was released in January 2017.  Forte is currently working on a 15.2 upgrade slated to be released in early September 2017.  Visit us again soon for updated information.

Area New Feature
Biospecimen Mgmt Configure the Working List display
Biospecimen Mgmt Sort specimens by entry order in Working Lists
Biospecimen Mgmt Set default annotation values in Specimen Collection Configuration templates
Biospecimen Mgmt Consolidate specimens in a storage subunit from the Storage Browse page
Biospecimen Mgmt Expanded demographic fields in Specimen Collection Console
Biospecimen Mgmt Directly access the selected protocol subject in the Subject Console from the Specimen Collection Console
Biospecimen Mgmt Specimen Import now has improved performance.
Financials The Budget Calendar now only shows the built number of cycles if a segment is not open ended. It only uses the No. of Cycles for Budget Calculations field for open-ended segments.
Protocols & Subjects Subject Status Change Notifications now take updates made to the subject threshold value into account if that notification has been sent at least once.
Protocols & Subjects The planned forms count for Subject Forms now omits forms associated with visits that will not be checked in because the subject has gone off treatment or off the study.
Protocols & Subjects When a user assigned to more than one Organizational Unit creates a protocol, the OU field no longer pulls in the first OU listed by default.
Protocols & Subjects Add optional segments to specifications
Protocols & Subjects Search on Short Title and filter by library in Protocol Search
Protocols & Subjects Show all treatment arms for a subject in Subject Search, with the option to limit results to active arms only
Protocols & Subjects Select specific statuses and arms to trigger a reconsent for consent documents within an IRB review
Protocols & Subjects In PC Console > [protocol] > Status > Task Lists, users can no longer accidentally double-click the Save button and create duplicate records.
Protocols & Subjects The PRMC No. field in ePRMS > Coordinator Console > Assigned > On Agenda now correctly populates from the PRMC No. field on the PC Console > Main > Management tab, and the PRMC No. is retained in both places.
Protocols & Subjects Scheduling a procedure that has special characters such as the percent (%) character in its name no longer causes an error. This issue previously occurred when scheduling procedures via the Visits/Schedules link on the Procedure Details page.
Reporting All documented visits are now included in the Planned Visit Report if the Planned Visit date is in the report search parameter range.
Reporting Users are now able to correctly select available management groups while working with reports such as the Low Accrual Report and the Open or Suspended Protocols At Or Over Target Accrual report.
Admin & System-wide Add a prefix to the protocol number when using automated protocol numbering
Admin & System-wide Updated user interface
Admin & System-wide Transition from staff and institutions to contacts and organizations
Admin & System-wide Improved user access through the concept of organization access
Admin & System-wide Stacked roles and updated permissions
Admin & System-wide 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.
Admin & System-wide More in-system configuration for settings that used to be available only from the database
Admin & System-wide Additional support for authentication
Admin & System-wide Inactive management groups can no longer be selected in a staff (now called contact) record.