UKCRO Mission and Services by Division

UKCRO (UK Clinical Research Organization)

Mission:
The mission of the UK Clinical Research Organization (UKCRO) is to provide clinical and/or translational research faculty and staff with the infrastructure and support needed to facilitate public access to clinical trials.  UKCRO provides coordination and support for all UK Chandler Medical Center (UK CMC) clinical research.

Administrative and Regulatory Services:

• Overall project coordination
• Development of regulatory documents
• Submission of IRB forms
• Investigational New Drug (IND) application preparation
• VA submission
• Budget preparation for industry-based trials
• Study feasibility assessment
• Subject availability information
• Grant Management (establish 4 account, track, monitor billing, manage study costs, invoice sponsor, other)
• Development of Electronic tools and forms to streamline research processes

Operations/Study Coordination/Nursing Services:

• Coordinate inpatient and outpatient studies
• Implementation of phase I, II, III, IV clinical trials
• Clinical procedures (vital signs, EKG, PK, drug dispersion, inoculation, observation, other procedures)
• Obtain, process and ship lab specimens
• Patient education
• Administer survey/questionnaires, screening patients for inclusion, chaperone examinations, chart review
• Adverse event surveillance, attend site visits, develop study and source document, complete source and case report forms, maintain regulatory documents

Marketing:

• Facilitate interaction between faculty and industry sponsor to initiate studies
• Providing compliance assistance and guidance
• Representation of UK research at national meetings
• Volunteer outreach to inform study volunteers of research opportunities
• Development of flyers and newspaper ads
• Placement of study advertisements (hospital, KY Clinic wall mounts, kiosk, campus sites)
• Collaborator with UK CMC Public Relations

Compliance:

• Coordinating internal fiscal assurance programs
• Monitoring for university and federal cost accounting standards
• Ensuring clinical management and fiscal compliance
• Providing compliance assistance and guidance
• Pilot testing of electronic study management software

Education:

• Development of Resource manuals and training programs
• Coordinator Training Course
• Clinical research investigator training
• Monthly Clinical research workshops offered through “brown bag” luncheon series
• Volunteer education and outreach
• Individual or customized training presentations

Clinical Research Facility:

Outpatient Unit

• The UKCRO is located on the second floor of the KY Clinic
• This facility is available for all Research Investigators conducting trials
• Reception area, seven exam rooms, infusion room with two chairs
• Lab processing and shipping area
• Three monitor areas with remote computer connections
• Conference room, secured storage, cold kitchen
• Access to University of Kentucky Hospital

Inpatient Unit

• Located in the General Clinical Research Center (GCRC)
• GCRC laboratory
• Metabolic kitchen

Web sites:

For Clinical Trial Volunteers
http://www.ukclinicalresearch.com
CenterWatch
http://www.centerwatch.com/professional/pro711.html