Clinical Research Office: Clinical Protocol and Data Management

The regulatory unit is responsible for:    

• Regulatory study startup and maintenance including IRB application submissions, site and sponsor regulatory documentation management for interventional oncology studies led by Markey Investigators. We have study staff dedicate to study startup and to study maintenance.  
• Liaison between study team, internal ancillary groups (e.g. Investigational Drug Service, Biospecimen Procurement and Translational Pathology, etc.), internal committees and study sponsors. 
• Maintain audit ready electronic and hard copy records for interventional oncology studies throughout the life of each study and works with team to ensure study records are archived per applicable regulations. 
• Maintains clinical trials management system (OnCore) to track regulatory submissions and ensure study documents (e.g. protocols, consents, patient materials, etc.) are available to the study team at all times. 
• Collaborate with UK faculty and Investigator Initiated Trials Development Office to activate Investigator Initiated trials including FDA IND/IDE applications and IRB submission development and maintenance. 

For more information contact:
mccreg@uky.edu

The research finance team assists with both pre- and post-award activities. Our office works with UK’s Clinical Research Support Office (CRSO) for services including coverage analysis, OnCore study calendar creation which is the basis of our budget. Our office prepares study budgets and conducts budget negotiations with industry-sponsored trials. We facilitate contract execution in coordination with the Office of Sponsored Projects (OSPA). We are responsible for clinical research charge review, investigators and ancillary service payment, and monthly account reconciliation. 

For more information contact:
Molly Gosky, Finance Manager
Mary.Gosky@uky.edu

The IITs Office supports Markey clinical investigators with development, launch and maintenance of interventional treatment (therapeutic-intent) investigator-initiated trials.

The IITs Office works in partnership with each unit of the Clinical Research Office (CRO) from concept development all the way through maintaining IITs and study close-out. While investigators identify clinical treatment interventional trial concepts the IITs Office is available for assistance with study development. The IITs Office collaborates with CRO Finance and the Markey Business Office (AD for Administration) to identify viable funding sources and assists faculty investigators as necessary.

The IITs Office also provides a multidisciplinary approach to evaluate target population, study intervention, preliminary study calendar, and link to salient clinical research team members for specific needs of the trial (finance, regulatory, clinical data managers, and clinical research coordinators and research nurses).

The IITs Office assists investigators with submission to CCART, Feasibility Review Committee (FRC) and Protocol Review and Monitoring Committee (PRMC) as well as submitting the protocol to CRO Finance for budget considerations.

Please reach out to the IITs Office for the protocol template.

For more information please contact the IITs Office at IITOffice@uky.edu.

The Multi-Center Research Unit will oversee the management and execution of MCC IIT multi-center studies at NCI Designated and/or Comprehensive Cancer Centers.  The MRU works closely with MCC CRO, PMC, and MCC QA offices to provide operational and regulatory support and services.  The MRU also act as the central source for coordinating all activities between the internal teams and external teams.  

For more information contact:
Bryan Courtney, Clinical Trials Management Director
bryancourtney@uky.edu

We ensure all clinical reporting requirements are met such as NCI Clinical Trials Reporting Program (CTRP).

For more information contact:
April Bramel, Compliance Officer
April.Bramel@uky.edu