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.
To address this need, the UW School of Medicine and Public Health uses the Online Collaborative Research Environment-Clinical Research Management (OnCore), making it available to all researchers conducting clinical research studies.
OnCore differs from REDCap, which is an application for members to use in building and managing data collection forms.
OnCore is one of the data management tools offered through UW. Check out the Data Management Tools page for information on OnCore vs REDCap.
OnCore supports a wide range of functions to enable the investigator and study team to meet modern data requirements, financial expectations, and government policies. The software:
- Provides protocol management functions
- Tracks subject enrollment (e.g. subject screening, scheduling) and safety (adverse event tracking)
- Supports budget development, billing, and fiscal management
- Generates summary reports
The intent is to ease the burden of the individual researcher, and unify protocol management within research programs and across multiple researchers at multiple sites, enhancing protocol integrity and regulatory compliance efforts.
OnCore is required for the following protocols;
- All 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)
- Devices (including Emergency, One-Time and Humanitarian Use Device)
- Radiation therapy or medical imaging
- Protocols that use an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)
- Protocols that use University of Wisconsin Hospital and Clinics (UWHC) or University of Wisconsin Medical Foundation (UWMF) ancillary services (including Clinical Research Unit) that will result in UWHC or UWMF charges or fees that will be billed to the subject or research account (NOTE: subjects participating in this protocol category must also be registered through UWHC Patient Registration)
- All cancer-related studies conducted at the UW must be reviewed by the UW Carbone Cancer Center Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation
Request an OnCore user account here.
There is not cost to researchers.
All UW staff members
Refer to the OnCore Help & Documentation page on the UW KnowledgeBase for responses to Frequently Asked Questions, Help Guides, and scheduled training.