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 Institute of Clinical and Translational Research (ICTR) and the UW School of Medicine and Public Health chose the Online Collaborative Research Environment-Clinical Research Management (OnCore), making it available to all researchers conducting clinical research studies. Many workflows and processes have been identified and standardized within ICTR OnCore for use across the spectrum. ICTR OnCore is supported by the UW Bioinformatics Computing Group and managed by two full-time ICTR staff.
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 ICTR. 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;
- Offers optional data management tools (e.g. electronic case report forms, data validation and exportation capabilities);
- 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.
ICTR 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)
- Protocols under the purview of the ICTR Data Monitoring Committee
OnCore also offers optional data entry and data management capabilities, through the use of electronic Case Report Forms (eCRFs). This functionality is optional for most studies, but is required for those under the review of the ICTR Data Monitoring Committee or the Study Monitoring Service, email Compliance@lists.wisc.edu.
Studies that use the OnCore Clinical Trials Management Software for data collection and management 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 UL1TR000427. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.”
Request an ICTR OnCore user account here.
The cost of eCRF form development is determined on a study-by-study basis based on the number of eCRFs that are needed. Contact ICTR OnCore Support team for more information.
Refer to the ICTR OnCore Help & Documentation page on the UW KnowledgeBase for responses to Frequently Asked Questions, Help Guides, and scheduled training.