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CRU Clinical Research Services | National Institute of Environmental Health Sciences
CRU Clinical Research Services | National Institute of Environmental Health Sciences
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Clinical Research Unit, North Carolina
Table of Contents
Who Is Eligible to Use the CRU Resources?
What Kind of Research Can Be Done at the CRU?
Do You Have an Age Limit?
What Are the Fees?
What Services Are Offered by the CRU?
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
Regulatory
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
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Last Reviewed: December 30, 2025