Clinical Trials Management System
OnCore is the CTMS that supports clinical research activities at the University and allows for enhanced clinical research study management that supports clinical research activities at the University of Utah. Along with additional modules (eReg, and Participant Payments), OnCore will provide the entire University research community with efficient processes to manage financial aspects and participant requirements to maintain compliance at our institution. OnCore and its supporting modules can be leveraged alongside other systems that we currently use to share information across campus (Epic/Epic Research, ERICA, EDW, RedCap, etc.) and aid in recruitment.
OnCore Registration Requirement
All research involving human participants that meets one or more of the following criteria must be entered into OnCore:
Please contact us with any questions about the registration requirement.
Any research study that includes a prospective clinical item including lab tests, blood draws or x-rays. This is the case regardless of whether the clinical item(s) will be paid for by the research project (study sponsor) or the participant’s insurance.
A clinical item may include any treatment (e.g., drug, device), intervention (e.g., randomization of patient to one of two standard of care treatments), or clinical procedure (e.g., blood draw, MRI, physical exam, pathology order. All clinical services must be billed.
Any study that meets the definition of clinical trial by the requisite sponsoring agency (e.g. NIH*), regardless of inclusion of prospective clinical items.
*NIH Definition of a Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Any study where a participant receives any payment that meets the current University policy for remuneration (i.e., cash, check, gift certificates, gift cards, or other items of value).
*OnCore start up/annual fees will NOT be assessed if using OnCore for participant payments only.