"Conducting Clinical Trials A-Z"

What institutional resources and support services are available at UK?                                                                                                                                                                                         
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.

CONTACTS:

For marketing of clinical trials: Roxane Poskin, phone: (859) 257-7856; email: roxane.poskin@uky.edu; 310 CTW Bldg.

For education or training needs: Belinda Smith, phone: (859) 323-8150; email: belinda.smith@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.

For fiscal compliance needs: TBA

For study coordination & nursing needs: Mary Wethington, phone: (859) 323-1751; email: mary.wethington@uky.edu; C201 Kentucky Clinic.

For grant management and administration needs: Darin Cecil, phone: (859)323-2781; email: darin.cecil@uky.edu; C201 Kentucky Clinic.

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 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

Office of Research Integrity (ORI) 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, managed by the Office of Research Integrity (ORI). 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.

Investigational Drug Service (IDS)  The Investigational Drug Service (IDS) supports all clinical drug-related research conducted by investigators at the University of Kentucky Medical Center. The IDS provides the support needed to assure safe and efficient conduct of clinical drug trials including compliance with federal, state, and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requirements regarding investigational drugs.  All inpatient studies are required by Hospital policy to utilize the Investigational Drug Service. Any exceptions must be arranged in advance between the IDS and the Principal Investigator. It is encouraged, but optional for outpatient studies to utilize the IDS