See frequently asked questions, training schedules and user information here.
The University of Kentucky has adopted OnCore as its enterprise Clinical Trial Management System. OnCore was developed by Advarra Research Systems in Madison, Wisconson and was initially deployed at Markey Cancer Center in 2006. At the beginning of 2019, as part of the UK TRACTS project, the use of OnCore and its companion application, Insights (a Tableau-based Business Intelligence tool), will be expanded at the Markey Cancer Center and rolled out to the remainder of the University of Kentucky. When fully implemented, the University of Kentucky research community will utilize OnCore to track protocols, regulatory approvals, ensure billing integrity through the use of coverage analysis, research financial administration, accrual monitoring, and participant visit management.
Which Studies Will be Tracked in OnCore?
The University of Kentucky has established that all clinical trials meeting the National Institutes of Health (NIH) definition and any clinical study with UKHC billable items will be tracked in OnCore. The NIH decision tool (keep link that is currently on the page) is publicly accessible to help determine if the protocol meets this definition.
The following four questions can be used to determine whether a protocol meets the NIH definition of a clinical trial.
Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?
If the answer to the above questions is yes, the study will be tracked in OnCore, however, data entry requirements will vary based on billing compliance and sponsor invoicing needs.
UKHC billable items include any item or service provided by any healthcare professional who may or may not be part of the study team, but will be rendering medical care to patients as part of the study or is provided at a UKHC facility, regardless of payer.
For assistance determining if a study needs to be built into OnCore, please contact CRSOstudyassist@uky.edu.
CRSO Support Teams
CRSO OnCore CTMS Support team collaborates with Markey OnCore support services to manage end-user access, training, and reporting needs of research staff in departments campus wide.
CTMS.Support@uky.edu and firstname.lastname@example.org
CRSO Clinical Trials Administration and Billing Integrity (CTASBI) team build calendars and protocols and perform Medicare Coverage Analysis to facilitate billing integrity and compliance.
CRSO Financial support team assists research teams with financial management in OnCore
Additionally, the CRSO has staff that departments may opt to use for their protocol regulatory needs on a fee for service basis. These regulatory specialists can aid with initial IRB reviews, continuing reviews, and other mandatory results reporting to the IRB.