Clinical Trial and Clinical Research Support

The BTRF is the principal Core Facility providing laboratory support services for therapeutic clinical trials and non-interventional clinical research at UVA. We are a pass-through facility specializing in processing and handling of biospecimens being provided to a sponsor’s central laboratory and for use in correlative studies by UVA investigators.

• access to archival pathology specimens
• processing and aliquoting of blood specimens
• isolation of mononuclear cells from peripheral blood or bone marrow, with or without crypreservation
• processing and aliquoting of urine, saliva, ascites, and other biofluid specimens
• centralized biofluid processing for multi-site trials
• assistance with collection and processing of on-study biopsy specimens
• tissue collection from surgical pathology and outpatient clinics
• standard and specialized tissue sample processing and preservation
• temporary and long-term storage
• specimen pickup and transport
• assistance with shipping logistics
• dry ice
• budget development
• biosample protocol guidance for investigator-initiated studies
• support for correlative studies such as immunohistochemistry, RNA/DNA/protein isolation

You MUST complete these steps before the BTRF can perform any services for a study.

To initiate a request, users must first complete a BTRF Clinical Trial Investigator Agreement & Service Request form and provide copies of all necessary supporting documents (refer to the document checklist found on the last page of the form). Submit the signed Agreement form and supporting documents to the BTRF by e-mail or Messenger Mail.

The submission will be reviewed by the Biorepository Manager and BTRF Technical Director upon receipt, and a face-to-face meeting between BTRF personnel and key members of the study team will then be scheduled. This meeting is mandatory and must take place prior to the BTRF performing any study-related activities. Topics covered include the expected activities of the BTRF, specifics of specimen processing and logistics, review of materials/kits provided by the sponsor, and procedures for communication between the study team and the BTRF. An estimate of costs for the requested services will be provided by the BTRF which may be used for budgeting.

If not available at the time of the preliminary meeting, a PTAEO and a copy of your IRB-HSR approval page must be provided before the start of subject enrollment.

• Download BTRF Clinical Trial Investigator Agreement & Service Request form
• Submit completed forms and supporting documents to Pat Pramoonjago pp6f@uvahealth.org
• Alternatively, submit by Messenger Mail to the BTRF Lab, Box 800904.