The OnCore clinical trial management system (CTMS) provides research teams with a comprehensive, go-to system that supports virtually all aspects of a clinical trial.
A comprehensive, go-to system that supports virtually all aspects of a clinical trial.
The CTMS offers comprehensive features for managing studies, electronically capturing data, creating custom reports, and supporting financial activities.
OnCore provides research teams with a go-to place for managing the day-to-day aspects of a clinical trial:
- Information sharing – Research team members can access key study information, including protocols, consent forms, visit schedule, checklists, participant details, and electronic case report forms.
- Dashboards – Consoles enable users to quickly and clearly view information that’s pertinent to them. For example, the PI console displays information about accrual and protocol status.
- Notifications – Automated email notifications support communication and efficient workflows, IRB notifications, and protocol and subject status.
- Research participant management – Provides consistent eligibility and consent tracking, a study-specific calendar detailing planned and actual participant visits and adverse event tracking.
“OnCore is incredibly comprehensive, and gives us many things we need for a clinical trial in one spot. Now we can more easily collaborate with team members, manage financial activities, and compile information for sponsors.”
—Katie Mellskog, RN, MS, Program Director, Masonic Cancer Center Clinical Trials Office OnCore user for approximately 15 years
Collecting data and creating reports
- Data management – Collect, house, and track protocol, study, administrative, financial, and safety data in a way that’s consistent among studies. View a comparison of OnCore and REDCap.
- Custom reports – Quickly generate meaningful reports that can support decision-making for individuals such as PIs, administrative leaders, and finance staff. Reports can be created for accrual, financials, participant safety, staff workload, and a wide range of other metrics.
- Visit-level data – Electronic case report forms (eCRFs) associate with the calendar in OnCore, and can be assigned to specific visits and exported to Excel and SAS at any point during a trial’s life cycle.
- BioSpecimen Management - BioSpecimen Management Services (BSM) track specimens associated with an OnCore research subject and their specific research clinical visit.
- Budgeting – Supports pre-award budget development.
- Pricing – Links study procedures to a single rate list provided by clinical providers and labs. OnCore is used to request and record quoted prices and billing accounts for Fairview Health Services and University of Minnesota Physicians (UMP) billable items.
- Projections – Provides financial projections for clinical provider charges based on the linked study calendar and priced procedures for visits that have occurred.
- Earned revenue – Provides an accurate, timely view of what items are ready to be invoiced to a sponsor.
- Billing compliance – Tracks billing designation to note which procedures get billed to insurance vs. research accounts.
OnCore integrates with other enterprise-wide systems to streamline processes, improve accuracy, and support recruitment efforts:
- Epic EHR – System users can populate Epic, Fairview’s electronic health record (EHR), with some of the data from OnCore, and vice versa. This includes real-time study participant status updates, calendars, study information, and details about consented patients.
- Clinical Translational Research (CTR) Portal – Systems integrate, with OnCore pulling information from multiple systems – including the CTR Portal – to ease study set-up, and a CTR Portal module that pulls data from OnCore for monitoring
- Other sites – Eases collaborations with other sites, as OnCore is used by academic medical centers, cancer centers, and health care systems across the country.
“OnCore serves as a central location for study data/documents to be stored and accessed by both study staff and service providers, which is vital to integrating research into clinical care across multiple Fairview locations."
—Fairview Research Administration team
Regulations and standards
- Tracking – Tracks submissions, communications, and actions for various regulatory bodies including scientific review committees, FDA, IRB, and data safety monitoring committees.
- Automated notifications – Generates automated notification alerts prior to IRB expiration, and to inform the research team of key status changes made by regulatory staff (e.g., regulatory tracking information entered).
- Support for standardization – “Hard stops” and checklists help administrative leaders ensure standard operating procedures (SOPs) are consistently followed, supports adherence to a set of common processes, and allows for metrics tracking.
- Data security – Secures data and allows audit logging of research data modifications.
- Permissions and user management – Ability to limit access, such as to specific studies or system areas.