OnCore: Determining Study Eligibility

To ensure proper study management and compliance, it is essential to identify which studies need to be included in the OnCore system. 

At UVM, a study must meet at least one of the following criteria to be eligible for inclusion in OnCore:

 

  • Cancer Focus: Studies with a primary focus on cancer research or oncology clinical trials. 
  • Hospital Resource Utilization: Studies that utilize any hospital resources, such as inpatient beds, outpatient clinics, or diagnostic services.
  • Regulatory Review: Studies that require a CHRMS (Committee on Human Research in the Medical Sciences) or CHRBSS (Committee on Human Research Involving Behavioral & Social Sciences) full committee review.
  • Clinical Trial Definition: Studies that meet the NIH definition of a clinical trial, typically involving interventional research.
  • FDA Oversight: Studies that are FDA-regulated or have any level of FDA oversight.

It's imoortant to note that some expedited and/or exempt studies may also need to be included in OnCore based on institutional policies or specific study requirements. The OnCore team will provide guidance and support in determining study eligibility on a case-by-case basis.

For more information, please contact the OnCore team:  OnCoreSupport@med.uvm.edu