The University of Kentucky offers numerous mechanisms to support faculty and staff engaged in clinical research:

Markey Cancer Center (MCC) Clinical Research Coordinating Center

The Cancer Center has been charged with quality assurance of cancer clinical research at the University of Kentucky. The Clinical Research Coordinating Center undertakes this process.  As part of this quality assurance process, all cancer-related clinical trials proposed to be conducted within the University of Kentucky, A.B. Chandler Medical Center must be endorsed by the Cancer Center’s Clinical Care and Research Teams (CCART) and reviewed and approved by the Protocol Review Committee (PRC). This is a single, concurrent process which we complete within three weeks of submission. Investigators are provided with a written review within four working days of the PRC meetings which are held twice each month.

Investigators are encouraged to discuss research concepts with the respective disease-specific CCART when considering or writing a protocol to enhance programmatic development and protocol quality, although this is not required for the review process outlined above. 

Contact Kristie Summers, CCRP: phone: (859) 323-5127, email kristie.summers@uky.edu.

Surgery Clinical Research Investigational Protocol Team (SCRIPT)
The primary goal of SCRIPT is to provide the infrastructure necessary for clinical investigators within the Department of Surgery to conduct research. SCRIPT provides ongoing support for industry sponsored trials (Phase I-IV), NIH/federally sponsored, and/or investigator initiated protocols from pre-study negotiation through project completion. Services offered by SCRIPT include: negotiation and execution of clinical trial agreements, budget development and negotiation, regulatory administration, grant management and oversight, clinical coordination (data collection/management), and assistance to faculty members in achieving their goal of publishing and furthering their research interests.
Contact: Linda Rice, R.N., Director, SCRIPT, phone: (859) 323-9527; email: lsrice0@email.uky.edu;

UK Clinical Research Organization (UKCRO)
The UKCRO supports faculty, staff and the pharmaceutical industry by facilitating clinical research endeavors. The UKCRO offers clinical research administrative start-up services, costs analysis, budget development and grant management. Other available services include study coordination, a research clinic to conduct phase I through IV inpatient and out-patient trials, marketing (national promotion, advertising development and recruitment support), advising on state and federal regulatory issues and compliance requirements, and training workshops.
For marketing of clinical trials: Roxane Poskin, phone: (859) 257-7856; email: roxane.poskin@uky.edu; 310 CTW Bldg.
For study initiation and regulatory issues: Shirley Warren, phone: (859) 323-8148; email: shirley.warren@uky.edu; C201 Kentucky Clinic.

Clinical Trials
Information about currently enrolling clinical trials is available from the UKCRO Web site through links to the listing of UK clinical trials on CenterWatch and to departmental Web sites describing their current clinical trials.

General Clinical Research Center (GCRC)
The GCRC is an NIH-funded center that supports both in-patient and out-patient clinical research. The GCRC primarily funds pilot studies and supplements to NIH-funded projects. Its resources are available to all clinical investigators at the University of Kentucky.
Contact: Nancy Kukulinsky, Ph.D., Director, GCRC, phone: (859) 323-6623; email: nkuku2@uky.edu.

Office of Research Integrity (ORI)
The Office of Research Integrity (ORI) provides support for six federally mandated review committees, three Medical and a Nonmedical Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Radioactive Drug Research Committee (RDRC). ORI oversees mandatory training for human subjects protection and provides training on HIPAA regulations concerning research involving human subjects. In accordance with federal and institutional regulations, any undertaking in which a University faculty, staff or student investigates and/or collects data on human subjects for research purposes must be reviewed by the appropriate IRB. ORI also supports the institution in promoting ethical conduct of research and educating UK students and employees regarding research misconduct regulations. Copies of protocol application forms, information on policies and procedures, and UK's Statements of Assurance can be obtained from ORI.

Office of Sponsored Projects Administration (OSPA)
OSPA is responsible for reviewing and accepting all sponsored project agreements awarded to UK through the University of Kentucky Research Foundation. The department has an individual dedicated exclusively to negotiating clinical trial agreements.