The UK Clinical Research Support Office (CRSO) supports investigators and clinical research study teams in departments, centers, and colleges across campus to conduct clinical research. The office aims to reduce administrative burdens, enhance compliance, and help remove barriers to enable efficiency, internal/external collaboration, cost recovery, and growth of clinical trials at the university. The CRSO is supported by UK HealthCare, the University of Kentucky College of Medicine, the University of Kentucky Center for Clinical and Translational Science and the University of Kentucky Office of the Vice President for Research.
We review all clinical research studies to determine if the study meets the criteria documented on the CRSO Minimum Footprint for inclusion in the CTMS system, including the calendar development and the coverage analysis. The CTASBI Team will identify if a study meets the criteria for inclusion in the Epic (EHR) system based on the presence of UKHC billable items and services. Please contact us with any question about the Minimum Footprint, Coverage Analysis and Billing reviews at CRSOstudyassist@uky.edu.
Advarra Electronic Data Capture (EDC) is a 21 CFR Part 11 compliant EDC system that is available for UK researchers. In addition to a robust traceability of all data entered or modified within the EDC case report forms, Advarra EDC is integrated with Epic-Beaker to retrieve and post lab results automatically. The system will help streamline data collection/management, data monitoring/review, and incorporate an electronic signature approving all data collection instruments. This system will enhance overall data integrity and quality for investigator-initiated studies enterprise wide, especially those regulated by the FDA. For more information go to https://research.med.uky.edu/research-advarra-edc.
Effective March 1, 2019, all clinical research studies and amendments must be submitted to the CRSO for coverage analysis prior to budget finalization.