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, ICTR and the UW School of Medicine and Public Health have implemented the Clinical Trial Management System (CTMS), OnCore. Many workflows and processes have been identified and standardized within ICTR OnCore for use across the spectrum. ICTR OnCore is supported by the UW Health Informatics Team and managed by ICTR OnCore support staff. For more information, email ICTROnCore@ictr.wisc.edu
Click here for a detailed comparison of the OnCore vs. REDCap.
Login to OnCore here: https://oncore.ictr.wisc.edu/forte-platform-web/login
Request an OnCore user account, here.
ICTR OnCore Help and Documentation KnowledgeBase: https://kb.wisc.edu/ictr
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What does ICTR 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
- offers optional data management tools
- electronic case report forms
- data monitoring and validation
- data export capabilities
- generates reports for study teams and program managers, such as accrual reports, NIH progress report demographics information, etc.
The intent of the ICTR 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 ICTR OnCore required?
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)
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 may be required for those under the review of the ICTR Data Monitoring Committee or the Study Monitoring Service. The cost of eCRF form development is determined on a study-by-study basis based on the number of eCRFs that are needed. Contact the ICTR OnCore Support team for more information.
Protocols under the purview of the UW Paul P. Carbone Comprehensive Cancer Center should NOT be entered in the ICTR OnCore system as the Cancer Center uses its own version of OnCore, and must be entered there instead.
ICTR OnCore Training and Resources
The ICTR 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 questions that you are unable to find answers to, please contact the ICTR OnCore Support team.
Cost of Using ICTR OnCore
The use of the ICTR OnCore system is available at no cost to research teams, however the use of the optional ICTR OnCore data management functionality is available on a fee-for service basis resulting in data collection and electronic capture forms customized for your study with the assistance of the ICTR OnCore Support Team. For questions or form development estimates, contact the ICTR OnCore Support team.
Citing use of OnCore
Studies that use the ICTR 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 UL1TR002373. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.”