Nursing and Clinical Services
- Pharmakokinetic and pharmacodynamic sampling
- IV access--central line access and peripheral line placement
- Study drug administration, including infusions
- Phlebotomy and sample processing
- Conscious sedation and recovery
- Assistance with protocol development and implementation
- Point of care testing, including ECGs and urine pregnancy
After your study receives IRB and CTRC Oversight Committee approval, please contact one of our nursing team leaders to discuss the initiation of your study. Unless you have an uncomplicated outpatient study that does not involve PKs or infusions, you will probably need to schedule a nursing in-service. Nursing in-services should review the following topics:
- Study purpose and background
- Investigational agents to be used
- Needed patient assessments
- Data and/or specimen collections
- Study flow sheets and physician orders
CTRC Investigators' Lab
There are a few basic requirements for use of this facility:
- Investigators must request use of the investigators' lab in the CTRC addendum.
- In addition, basic safety and etiquette training training are required to use this service, as outlined below.
- Finally, and we stress this point, if investigators and their staff wish to retain access to the lab then they must keep the area safe and clean.
CTRC Investigators Lab Emergency Contact Information
- University Health & Safety Office: 962-5507*
- University Police: 911
- Hospital Health & Safety Office: 966-0691
- University Occupational Health (for injuries): 966-9119
- Health Link (for injuries after 4:30): 966-7890
*The Health and Safety Office can be reached after hours through the University Police at 911. Call the Health and Safety Office for any safety issues to include gas leaks and odors, chemical spills, or other lab emergencies. For smoke and fire emergencies, call 911.
Margaret Mangan, MS
Nutrition Obesity Research Centers (NORC)
Beth MacIntosh MPH, RD
Nutrition Research and Metabolism Services
Clarence Mayo Jr.
Please contact Beth MacIntosh for assistance planning your budget.
Estimates are based upon the following fee structure:
$20 per meal
$33 per hour for diet planning
$37 per hour for study implementation i.e. nutrition counseling, nutrition assessment,
indirect calorimetry, anthropometrics
Some research protocols need highly specialized research diets. These diets can be developed for a range of study designs and service needs. Many variations can be provided, from the control of one or more macro or micronutrients for a single test meal to several meals per day for weeks or months. The research dietitians and staff work throughout the study to ensure compliance and to enhance participant retention. NIH-developed software is used to calculate precisely controlled diets for the macro or micronutrients of interest. Diets are prepared by dietetic technicians specially trained in metabolic diet preparation and data collection. This data is provided to the investigator at the end of the study in electronic format. The following are examples of nutrients controlled in recent studies:
- Pharmacokinetic and food effect bioavailability
- Nutrients affecting Cytochrome p450 enzymes
- Carbohydrate, Protein, Fat
- Ketogenic and Atkins type diets
- Glycemic Index and Glycemic Load
- Heterocyclic Amines
- Low antioxidant liquid formula
- Sweet Taste Test of variable sugar solutions
- Active Culture and Placebo Yogurt Randomization
- Fatty Acids (omega-3 and omega-6)
The research dietitian is a valuable asset to your study team, bringing nutrition knowledge and research expertise to your protocols. The dietitian provides consultation for study design with consideration of research aims, possible confounders, subject burden, food safety, nutrition status, research methodology, grant budgets, and available resources to accomplish your research goals. When needed, investigators are assisted with development and validation of new research methods. Throughout the study the research dietitian works closely with vestigators to ensure the integrity of the study. The dietitian's expertise in study implementation and attention to detail at every step is essential to the achievement of your research goals. The research dietitians have unique knowledge and experience in data collection methods and in the analysis of nutrient intake. You will be given electronic datasets that are updated at regular intervals throughout your study and will receive assistance with manuscript preparation as needed. The body composition laboratory is equipped with state-of-the-art equipment used only for the conduct of research. With ten years of experience, we are knowledgeable about research measurements used in body composition studies, the data generated from those measurements, and management and analysis of that data. The equipment available includes:
- DEXA for bone densitometry and body composition
- Peripheral QCT for bone structure (measurement of cortical and trabecular bone)
- Ultrasound heel sonometer for bone density
- Indirect calorimetry for measurement of resting energy expenditure and doubly labeled water studies
- Bioelectric Impedance Analysis
- Anthropometric measurements including skinfolds and circumferences
- Actigraph accelerometers for measurement of physical activity
- Physical Activity Questionnaires
If you need other resources, we will work with other Centers to help you obtain the methods, equipment, and resources needed to carry out your research.