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 that utilize any AHC resources (e.g. faculty, staff, facilities, equipment, or funding) for study management 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.
These studies must be entered into OnCore when either of the following is true:
- Studies requiring approval through the UMN IRB (non-exempt) that also require individual subject study specific consent forms, or
- Any other research studies using Fairview or University of Minnesota Physicians services OR billing to research participant or third party (i.e., insurance)
Note that the requirements above apply even when studies are ceded to an external IRB.
It is optional to enter these studies into OnCore unless required by Fairview:
- IRB-exempt studies
- Research using pre-existing data (e.g. retrospective chart review)
- Humanitarian Use Devices (HUD) registration form protocols
- Studies managed by the following groups that don’t utilize Fairview/UMP billable services:
VA Medical Center
School of Public Health (SPH)
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.