Clinical Research Unit, North Carolina

Clinical Research Unit scientists and staff
Clinical Research Unit staff. (Photo courtesy of Steve McCaw)

The Clinical Research Unit (CRU) is an ambulatory research facility on the NIEHS campus committed to providing investigators a broad range of clinical research services. With a specialized facility and multidisciplinary staff, the CRU supports clinical research through all study stages from concept development to obtaining final results.

Who Is Eligible to Use the CRU Resources?

Services are available to NIEHS investigators and extramural collaborators.

What Kind of Research Can Be Done at the CRU?

We currently support execution of all early phase clinical trials and investigator-initiated studies. Studies may involve either healthy volunteers or participants with specific diagnoses.

Do You Have an Age Limit?

We currently work with participant populations ages 8 and above.

What Are the Fees?

As a NIH core facility, the CRU provides services free of charge to NIEHS investigators. We also attempt to cover costs for extramural collaborators, to the extent possible. A resource review determines final cost structure for any study planned at the CRU.

What Services Are Offered by the CRU?

The CRU offers a wide range of services to support your clinical research project. The following is a list of current research activities. New services may be added by request.

Biobank and Data Registry

Stored DNA, serum, plasma, urine, house dust, stool, saliva, and sputum along with medical data are available to investigators for pilot studies.

Clinical Procedures

  • Administrative services:
    • Electronic consent (iMED)
    • Medical record management
    • Patient admissions in collaboration with NIH Clinical Center
    • Patient compensation for study procedures and visits
    • Travel reimbursement
  • Clinical procedures:
    • Adrenocorticotropic hormone (ACTH) stimulation testing
    • Allergen testing
    • Anthropometric measurements
    • Behavioral and psychiatric assessments
    • Bronchoscopies and lavage
    • Cardiac monitoring
    • DEXA scan
    • Exercise testing
    • Female cycle analysis
    • Intramuscular and subcutaneous Injections
    • Intravenous infusion pump
    • Intravenous access insertion
    • Medical assessments
    • Medication administration
    • Metabolic evaluation (Bod Pod®, Tanita® scale, resting exercise expenditure, resting metabolic rate, oxygen consumption)
    • Nursing assessment
    • Oral glucose tolerance testing (OGTT)
    • Overnight observation
    • Patient education
    • Patient monitoring
    • Pelvic and/or breast ultrasounds
    • Pelvic examination - assist and set up
    • Pharmacokinetic (PK) sampling
    • Phlebotomy
    • Physical exams
    • Pill swallow instructions for pediatrics
    • Point of care testing (pregnancy, rapid influenza A & B, blood glucose, hematocrit, cotinine tests)
    • Pulmonary function tests and spirometry
    • Pulse oximetry
    • Questionnaire administration
    • Sample collection (blood, urine, saliva, dust, skin, stool, sputum, nasal, hair, and nails)
    • Skin punch biopsies
    • Treatment monitoring
    • Vital signs

Clinical Space and Equipment

  • Fitness/lifestyle assessments equipment:
    • ActiGraph™ medical grade wearable for continuous home monitoring of physical activity and metabolic/biometric profile
    • Bod Pod® cabin for body composition measurement and metabolic status evaluation
    • COSMED Quark Resting Metabolic Rate (RMR) Metabolic Cart for metabolic measurements including resting energy expenditure and respiratory ratio
    • Treadmill and exercise bicycle for stress testing
  • General medicine equipment:
    • Baxter IV Infusion Pumps
    • ECG monitor
    • End-tidal C02 monitor
    • Natus® SleepWorks™ system for polysomnography to monitor sleep stages during overnight studies
    • Omnicell® medication dispensing system
    • Portable ultrasound machine
    • Vein finder transilluminator light device
  • Pulmonary medicine equipment:
    • Bronchoscopy
    • FeNO
    • Pulmonary function including methacholine or bronchodilator challenges
    • Smokerlyzer
  • Reproductive medicine equipment:
    • Hormonal cycle tracking kits
    • Ultrasound apparatus and probes for uterine/ovarian visualization
  • Space:
    • Adult exam rooms
    • Bronchoscopy suite
    • Medical records room
    • Observation Room
    • Overnight procedure room
    • Pediatric exam room
    • Pharmacy preparation room with Omnicell
    • Procedure room
    • Pulmonary function testing room
    • Recovery room
    • Waiting area

Data Management

  • Data services:
    • Coordination and preparation of data for final analysis
    • Data analysis
    • Data cleaning, coding, and merging
    • Fulfillment and de-identification of data requests
  • Development and implementation of:
    • Data abstraction
    • Data collection forms and surveys/questionnaires
    • Data management plans and study design
    • Data quality, integrity, and participant monitoring reports
    • Electronic distribution of surveys
    • Electronic web-based databases

Laboratory Services

  • Human biospecimen testing services:
    • Bar-coded labels and sample tracking utilizing BSI®
    • Cell isolation (PBMCs, CD14+)
    • Collaboration with NIH Clinical Center Laboratory, LabCorp and Quest
    • Complete metabolic panel
    • Customizable Architect i1000SR chemiluminescent immunoassay analyzer capable of testing 147 different hormones and cytokines
      • Anti-nucleocapsid IgG/SARS-CoV-2 IgG
      • Anti-RBD-Spike IgG/AdviseDx SARS-CoV-2 IgGII
    • Gradient centrifugation, magnetic beads & fluorescence-activated cell sorting (FACS)
    • ImmunoCAP Phadia 100® diagnostic testing
      • Allergen-specific Immunoglobulin E (IgE)
    • Liver function, kidney function, glucose testing
    • Microbiome DNA Extraction
    • Nonwaived tests
    • Pharmacokinetic (PK) specimen processing
    • Preparation and routing of specimens for immediate analysis
    • Preservation and shipment of ambient, refrigerated, and/or frozen specimens
    • Processing of blood, urine, saliva, dust, skin biopsies, stool, sputum, nasal, hair, and nails following protocol specific instructions
    • Short-term and long-term specimen storage including ambient, refrigerated (4°C), and frozen (-30°C, -80°C) temperatures
    • Specimen shipment packaging and tracking for confirmation of shipment receipt
    • Sputum analysis for research quality determination, and sputum eosinophil counts
  • Space:
    • Clean supply room
    • Equipment Room with autoclave
    • Freezers and refrigerators
    • Lab Rooms

Protocol Development

  • Consultations for study design and study feasibility analysis
  • Development of longitudinal and multi-visit protocols
  • Development of questionnaires
  • Development of research protocols, IRB submission packets, scientific review submissions and response coordination

Study Management

  • Coordination of:
    • Enrollment and consenting
    • Facility preparation
    • Participant compensation and travel reimbursement
    • Prescreening and scheduling
    • Protocol specific training
    • Recruitment and participant tracking
    • Recruitment and screening
    • Study kick-off meetings
    • Study timeline tracking
  • Develoment of:
    • Recruitment materials including posters, flyers, newspaper and magazine advertising, bus signs, social media promotions
    • Recruitment strategies and campaigns
  • Study close-out management:
    • Coordination of data validation and final dataset delivery
    • Final monitoring visit
    • IRB close out packet preparation


  • Quality assurance:
    • Audit preparation
    • Coordination of study monitoring
    • Development of study specific procedures
    • Enrollment, protocol compliance and adverse events reporting
  • Support for:
    • Human subjects research training
    • Investigational new drug application (IND) preparation and implementation
    • IRB submissions
    • Management of regulatory compliance
    • Material and data transfer agreements
    • Protocol reviews and approval tracking
    • Protocol amendments