Academic centers contend with thousands of clinical trials being conducted simultaneously in which there are many challenges ranging from limited resources to meeting evolving regulatory requirements. In a decentralized environment, it is difficult to maintain consistency, data integrity, and compliance across all realms.
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. Help choosing between clinical data management tools.
Historically, there were two versions of OnCore used at UW-Madison:
- UW ICTR instance for Non-Oncology protocols
- Carbone Cancer Center (UWCCC) instance for Oncology protocols
Effective May 31, 2022, both Oncology and Non-Oncology protocols will be managed in a single merged instance known as the WISC Instance, supported by the SMPH Informatics Team.
- For more information see OnCore: Integration Program and SMPH Research Informatics Overview
- If you have questions contact our support team: OnCore Support Help Desk Portal
- Login to ICTR Instance of OnCore (available through 12/31/2022)
- Request an OnCore user account
OnCore Help and Documentation KnowledgeBase:
This is an accordion element with a series of buttons that open and close related content panels.
What does OnCore Do?
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. The software:
- Provides protocol management
- Tracks subject enrollment and safety (adverse event and deviation tracking)
- Allows effective subject visit management
- Supports budget development, invoicing, and fiscal management
- Generates reports for study teams and program managers, such as accrual reports, NIH progress report demographics information, etc.
The intent of the OnCore system is to ease the burden of the individual researcher, and unify protocol management within and across research programs, enhancing protocol integrity, quality assurance and compliance efforts.
When is OnCore Required?
- 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:
- Drugs (including over the counter medications, vitamins, herbals, and supplements)
- Biologics (including vaccines and stem cells)
- 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 UW-CCC Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation.
- The use of the OnCore system is available at no cost to research teams.
OnCore Training and Resources
The OnCore Help and Documentation KnowledgBase offers users access to frequently asked questions, user guides and upcoming training opportunities.
This webpage is restricted to those with an active UW-Madison NetID.
If you have additional questions, please contact the OnCore Support Help Desk Portal.
Cost of Using OnCore
The use of the OnCore system is available at no cost to research teams.
Citing Use of OnCore
Studies that have used the ICTR OnCore Clinical Trials Management Software for data collection and management through the end of 2022 are asked to acknowledge UW ICTR support in publications arising from the project as described below:
“The project described was supported by the Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS), grant UL1TR002373. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.”
Please visit our OnCore Support Help Desk Portal if you have questions.