SOM Clinical Research Unit
The School of Medicine's Clinical Research Unit provides support for
the clinical research activities of SOM investigators.
Quick links to
sections on this page:
Physical
facilities
Clinical core facilities
Scheduling
Study staffing
Charges and funding
Outpatient studies: The interim outpatient Clinical Research Unit (CRU) on Barringer 2 includes three rooms with single beds that can be used for either overnight or outpatient encounters and one room specifically for outpatient encounters. Two of the overnight rooms are equipped for sleep studies. Space for staff, specimen processing, and a location to receive meals from the metabolic kitchen are provided.
Inpatient studies: Inpatient studies are done in two separate units of the Medical Center. The CPRU on 5E of the hospital will continue to be used primarily for studies conducted by the Department of Psychiatry but is available to all clinical investigators as needed. A portion of this unit has been renovated to contain a new spin lab for handling of research specimens. There are two inpatient beds in one room on this unit. A second inpatient unit is provided on 4C of the hospital. This unit consists of two inpatient beds in one room and is located next door to an exercise physiology core.
Spin Lab. Simple blood specimen processing is the responsibility of the clinic staff or the research team. The CTO will help arrange coordinator and phlebotomy support. More complicated (or large volume) processing and long term specimen storage should be arranged through the Biorepository and Tissue Research Facility.
Assay Lab (Contact: Dan Haisenleder, djh2q@virginia.edu). The assay lab has been transitioned to a SOM charge-back core while maintaining its current leadership. A list of user fees has been developed.
Exercise Physiology Core Lab (Contact: Art Weltman, alw2v@virginia.edu). The exercise and strength lab has been transitioned to a SOM charge-back core while maintaining its current leadership. A list of user fees has been developed.
Metabolic Kitchen (Contact: Theresa Zanetti, tz9h@virginia.edu; x4-2685). The physical location of this facility is within the Medical Center (MC) kitchen. It is expected that the MC food service will supply meals to all subjects who are in a hospital bed. Meals will be delivered to the Barringer 2 CRU for pick-up by volunteers.
Sleep Lab. Two beds for sleep studies are available in the Barringer 2 CRU.
Biostatistics support. Clinical investigators can obtain input on study design, data collection, and data analysis from the Department of Public Health Sciences, Division of Biostatistics.
The SOM Clinical Trials Office is responsible for scheduling research subjects for all SOM Clinical Research Units (Barringer 2, 5E CPRU, 4C CRU) as of June 13. The procedure for scheduling rooms in these areas is as follows:
- Study staff completes a Clinical Research Unit Subject Scheduling Request Form and forwards it to CRUschedule@virginia.edu.
- The CTO/CRU staff reviews the schedule and determines the availability of a room and staff for the dates/times requested. (If subject requires an inpatient room, the CTO/CRU staff contacts the MC Bed Center to schedule the appropriate bed.)
- The CTO/CRU adds the information to Office Tracker.
- The requesting study staff is notified via e-mail of the availability of the room on the dates/times requested (provides assigned room
Scheduling for meals and/or specific dietary requirements for each visit: contact Theresa Zanetti (tx9h@virginia.edu) to ensure that the dietary resources are available for the visit. Please include any known allergies, including food allergies.
Scheduling for Exercise Physiology: contact Judy Weltman
(982-3565) or Jason Rutkowski (982-3180).
- Administrative support. The CRU falls under the administrative supervision of the CTO. The CTO currently provides support for coordinator training, budgeting and billing, monitoring of investigator-initiated multicenter studies, and investigator-initiated INDs. The CTO will provide staffing for visits in the Barringer 2 CRU, schedule clinic room and bed usage, and assist with identification of temporary and wage nursing and phlebotomy support. The CTO will provide other incidental administrative support to investigators as needed, subject to availability of personnel.
- Temporary and Wage Staff. The CTO maintains a PRN pool of individuals who are willing to assist with studies.
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- These individuals will be trained in basic Good Clinical Practice standards and will be paid from an account maintained by the CTO. Investigators will be billed by the CTO to reimburse for the cost of these personnel.
- If study rooms are scheduled at times when permanent staff is not available, the PI/study team will be notified.
- Upon request of the PI or their study team, the CTO will identify and schedule individuals from the PRN pool.
- The CTO will notify the research team once the required staff is identified and scheduled.
- The PI/study team will be responsible for providing study-specific training of the PRN staff for the conduct of the study.
- Outpatient visits. The Clinical Research Unit provides staffing for the Barringer 2 CRU between 7 AM and 7 PM, Monday through Friday. Three nurses have been added to the CTO staff, to maximize flexibility for arranging coverage for the research needs of various investigators. Investigators who use the Barringer CRU have the option of using the clinic staff or of providing their own study staff for the conduct of studies in this space.
- Barringer CRU overnight stays. Staffing coverage for clinic use outside normal hours or for overnight stays will be arranged as described above.
- Inpatient beds. Staffing for research activities (e.g., nurses, phlebotomists) will be arranged with the assistance of the CTO as described above.
- All clinical research facilities will be transitioned to a charge back mechanism. Investigators should contact the CTO for information about room and bed charges and the individual cores for information about charges for core services.
