Investigational Drug Service
School of Medicine Clinical Research Unit
Institutional Review Boards (description/web site)
Federal Wide Assurance information for UVA IRBs
Biostatistical support (Dept. of Public Health Sciences, Division of Biostatistics & Epidemiology)
Phlebotomy and specimen processing services
Resources for research subjects
Participating in clinical research at UVA (VP for Research site)
Current clinical trials at UVA (as posted on clinicaltrials.gov)
Accessing clinical services and laboratories
Publishing clinical trials to web sites
Contracts and clinical trials agreements
Investigational Drug Service. This office, provided by the Medical Center, supports clinical drug trials from study design and submission of IND applications, to drug preparation, storage, logging, and dispensing. IDS can be contacted at x2-1048.
Institutional Review Boards. The IRB-HSR (Institutional Review Board - Health Sciences Research) is responsible for review and approval of studies involving biomedical/invasive procedures, comprising the majority of clinical research initiated at the School of Medicine. The IRB-SBS (Institutional Review Board - Social and Behavioral Sciences) is responsible for approving and overseeing non-invasive studies involving human subjects (e.g., survey studies). The IRB web site provides information on on-line applications, help in crafting protocols, and the protocol review and approval processes.
Phlebotomy and specimen processing services. Phlebotomy services are available on a fee-for-service basis through the Medical Center Clinical Laboratory at the Primary Care Center 1st Floor, Barringer 3rd Floor, 415 Fontaine 2nd Floor, and Northridge 1st Floor. Phlebotomists will collect specimens but will not accept responsibility for specimen processing or transport unless the specimen is being sent to the Medical Center Clinical Laboratory. Investigators choosing to perform phlebotomy in non-patient care areas must register with the Institutional Biosafety Committee. Specimen handling, storage, and shipping. The Biorepository and Tissue Research Facility (BTRF) will, on a fee-for-service basis, process specimens that require special handling or will be sent to UVA research laboratories. The investigator must transport the specimens to the BTRF. Contact Craig Rumpel, Biorepository Manager (car6m@Virginia.edu, 982-6453) to discuss anticipated costs and to arrange for accessing this service. In some instances, the BTRF may be able to arrange for sample pick-up. Investigators who process and ship their own specimens must register with and receive training from the Institutional Biosafety Committee.
Protocol development. The IRB offers help in protocol development, either directly or through IRB support personnel who are located in the various clinical departments of the medical school.
Accessing clinical services and laboratories. The Clinical Trials Office (CTO) can access current hospital laboratory charges for the development of budgets and can develop a billing plan delineating the procedures and interventions to be performed during the study as standard-of-care vs. investigational, and who (sponsor, insurer, patient) will be financially responsible for each. The CTO can negotiate the study budget with the sponsor and can generate invoices based on the billing plan, as study milestones are achieved. Contact: Katherine Richardson (x2-4383).