OnCore Overview
OnCore is a centralized Clinical Trial Management System (CTMS) that allows researchers to use one program to manage all components of clinical research while maintaining consistency and compliance across the institution.
If you have questions about how to use OnCore you can search the KB using the search tool at the top of this screen or contact our support team at Research Applications Support Help Desk Portal
When is OnCore required?
Even if your protocol is not required to be in OnCore, you are welcome to use OnCore for managing your clinical research protocol if you would find it useful.
Protocols that meet any of the following criteria must be entered into OnCore:
- Protocols that use University of Wisconsin Hospitals and Clinics (UWHC) (including the Clinical Research Unit - CRU) or University of Wisconsin Medical Foundation (UWMF) services, facilities or staff in which the services result in a UWHC or UWMF charge on the patient’s account.
- Therapeutic intervention protocols being conducted within the auspices of UW-Madison or the UW-Madison Affiliated Covered Entity (ACE) that involve the use of:
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- Drugs (including over the counter medications, vitamins, herbals, and supplements)
- Biologics (including vaccines and stem cells)
- Devices
- Radiation therapy or medical imaging
- Protocols that use an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)
- All cancer-related studies conducted at the University of Wisconsin must be reviewed by UWCCC Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation.
Other Data Capture Resources
Study teams wanting to capture study data can also use REDCap. More information is available at: REDCap: Overview
What functionality does OnCore have?
OnCore supports a wide range of functions to enable the investigator and study team to meet study, subject and data management expectations and financial and billing requirements.
- Protocol management
- Track enrollment and safety (adverse event and deviation tracking)
- Interface with Health Link
- Subject visit management
- Supports budget development, invoicing, and fiscal management
- Reports for study teams and program managers including accrual reports and NIH progress report demographics information.
Who is responsible for creating and maintaining protocols in OnCore?
Protocol Creation is dependent upon the protocol type:
- Oncology related protocols:
- All cancer-related studies conducted at the University of Wisconsin must be reviewed by UW-Carbone Cancer Center (UWCCC) Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation.
- PRMC staff will create the OnCore protocol record during their approval process.
- Other Research Groups (ORGs) - groups conducting cancer-related research studies that are not part of UWCCC should work with the UWCCC PRMC coordinator. Questions related to the PRMC review process, please call (608) 263-0169 or email the PRMC at protocolreviewmonitoring@uwcarbone.wisc.edu
- More information is available at OnCore: SMPH Oncology Other Research Group (ORG) Guide
- More information is available at OnCore: SMPH Oncology Other Research Group (ORG) Guide
- All other protocols - Non-oncology:
- The study team is responsible for creating the protocol in OnCore.
To request access please visit: OnCore: How do I obtain access to OnCore?
To receive training please visit: OnCore: Training Resources - Most non-oncology studies need to be evaluated for operational feasibility by the UW Health/SMPH Research Operations Committee (UROC). You can learn more about this feasibility assessment and its requirements at OnCore: UW Health/SMPH Research Operations Committee (UROC)
- The study team is responsible for creating the protocol in OnCore.