Studies to Enter into OnCore
The OnCore “minimal footprint” outlines what studies users should enter into the clinical trial management system, to help improve accuracy and consistency within units and across the University.
The guidelines below apply to human research studies across the Academic Health Center as well as any human research study using Fairview or University of Minnesota Physicians services.
Guidelines are effective as of Oct. 1, 2016, though many AHC units began following the guidelines prior to that date.
Users must enter these studies into OnCore:
- Studies under Health and Biological/Medical IRB Application
- Studies under Social and Behavioral Sciences IRB Application (faculty and student)
- Studies under Medical Record Chart Review IRB Application with individual subject study specific consent forms
- Any other research studies using Fairview or University of Minnesota Physicians services OR billing to research participant or third party (i.e., insurance)
If a study record exists in TASCS, it is not required to be entered into OnCore at this time. However, Cancer, Cardiovascular, and Psychiatry studies do have additional OnCore tracking requirements, even if they have been entered into TASCS. To learn more about these sites' requirements for studies in TASCS, please contact your department or the OnCore team at email@example.com or 612-626-3080.
Users have the option to enter these studies into OnCore:
- IRB-exempt clinical studies
- Research completed under medical record chart reviews using general medical record release consent
- Humanitarian Use Devices (HUD) registration form protocols
Academic Health Center requirements: Minimal footprint elements
Research areas may establish additional requirements for OnCore use, such as full tracking of Scientific and IRB reviews and communications. Detailed instructions and definitions are available upon receiving OnCore training.