Wake Forest Translational Science Institute (TSI)

Clinical Research Unit (CRU) Services and Tools

Focus

The Clinical Research Unit provides infrastructure to support clinical and translational research projects by providing access to clinical research space, resources, research support personnel and expertise.

Access

Investigators interested in applying for CRU support can access the application through WFBH’s eIRB system.  To receive assistance or learn more about the application process, please contact Teresa Reagan.

Dedicated Clinical Space

The Main Clinical Research Unit is a 6,623 square foot outpatient unit on the main floor of the hospital with 9 exam rooms, each containing a bed, stretcher, or exam table and the necessary patient care equipment; one procedure room; a metabolic kitchen with the necessary equipment to prepare special meals for studies with feeding components; and a CLIA-certified processing core, with state-of-the-art equipment and freezer capacity for tracking samples through FreezerWorks.^®   Standard operating Hours are 6:30AM-4:30PM.

The Geriatric Clinical Research Unit is a 2,500 square foot outpatient unit with 5 exam rooms, each containing a bed or exam table and necessary patient-care equipment; a consult room for participant meetings; a participant dining room; and a processing laboratory.  Standard operating Hours are 6:30AM-4:30PM.

Ancillary Support

The CRU may be able to provide support for laboratory, imaging, and genetic components of CRU-approved pilot studies.  Please contact Teresa Reagan for more information.

Acute Care Clinical Research Support

The Acute Care Research Unit provides assistance to research studies targeting human research participants with potential emergency conditions.  This includes participants in the emergency department or patients with time-sensitive disease processes.  Services include:

• Data Collection
• Participant Enrollment
• Participant Follow-Up
• Specimen Collection/Processing

Research Nursing Support

The CRU nursing staff provides research support for pediatric and adult research projects.  Inpatient and Off-Unit services are available on an as-needed basis.  Available services include:

• Ankle Brachial Index (ABI)
• Autonomic Function Assessments
• Basic Phlebotomy
• Bronchoscopy- Assist and Set-Up
• Cardiac Monitoring
• Clotting Time Procedures
• Complete Study-Specific Forms
• Conscious Sedation
• Eye (chart) and Hearing Exams
• Frequently Sampled Intravenous Glucose Tolerance Test (FSIGT)
• Intramuscular and Subcutaneous Injections
• IV Medication Administration
• LP- Assist and Set-Up
• Mental and Cognitive Testing
• Muscle Biopsy- Assist and Set-Up
• Oral Glucose Tolerance Testing (OGTT)
• Pharmacokinetics (PK) Studies
• Sample Collection (Blood, Sputum, Urine) (Including Saline Lock)
• Vital Signs (EKG, Blood Pressure, Height, Weight, etc.)

Bionutrition Support

The Bionutrition Service provides three main areas of service: food service, nutrition assessments, and nutritional education.  Services include:

• Aliquot Preparation for Meal Assays
• Anthropometric Body Measurements
• Bioelectrical Impedance (BIA) Measurement
• Collection and Analysis of Dietary Intake Data from Dietary Recalls or Records
• Computer-Assisted Food Weigh-Back System
• Computer-Assisted Menu Planning for Research Diets
• Controlled Nutrient Diet Planning, Analysis, and Preparation
• Development of protocol-specific Educational Materials
• Dietary Compliance Monitoring and Assessment
• Doubly-Labeled Water Testing
• Vitamin, Mineral, and Herbal Supplement Intake Assessment
• Food Frequency Questionnaire Administration and Analysis
• Health Snacks for Fasting Visits
• Indirect Calorimetry (RMR) Testing
• Metabolic Kitchen Services
• Nutrition Screening and Evaluation for Feeding Study Eligibility
• Nutritional Status and Dietary History Assessments
• On-Site and Pack-Out Research Meal Feeding
• Recipe Development
• Registered Dietician Services for Nutrition Counseling
• Self-Monitoring Tools Development, Implementation, and Analysis

Specimen Processing Support

The CRU Specimen Processing Laboratory provides processing support for blood, saliva, sputum, breast milk, urine, and fecal specimens in the Main and Geriatric Units.  The Laboratory is equipped with -70 Freezers, -20 Freezers, Refrigerators, refrigerated centrifuges, micro-centrifuges, micropipettes, and fume hoods.  Available services include:

• Buffy Coat Purification
• Collaboration with LabCorp and Institutional Core Laboratories
• IV Glucose Tolerance Testing
• Non-Waived Testing (YSI 2300 STAT Plus Glucose Analyzer)
• Oral Glucose Tolerance Testing
• Pharmacokinetic (PK) and Pharmacodynamic (PD) Specimen Processing
• Preparation and Routing of Specimens for Immediate Analysis
• Preservation of Specimens for Transport, Ambient, Refrigerated, and Frozen on Dry Ice
• Processing of Blood, CSF, Specific Cells, Sputum, Saliva, Breast Milk, Urine, Feces, and Tissue
• Real Time Results Reporting
• Short-Term Repository Storage
• Timed Urine Collection
• Validation of Point of Care Testing Instruments, Including Development of QC and QA Programs

Learn more about the Clinical Research Resources Program.