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?

Beginning July 1, 2024, all clinical research that involves human subjects and uses any SMPH space or UW Health resources, including access to patients, is required to be entered into OnCore.

• This policy applies to any study that requires the use of UW Health facilities, staff, equipment, resources, procedures, or patients OR occurs in any SMPH space involving human subjects.
  • Use the OnCore Usage Decision Tree to help determine whether your study needs to be in OnCore and what components are required
    
    
• The July 1 start date only applies to new studies. Those that are in process and are not already in OnCore are not required to add them retroactively.
  • For requirements before July 1, 2024, visit OnCore: Protocol Entry Requirements

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.

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:

1. 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
       
       
2. 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)