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Table of Contents

Program Leadership

 John McHutchison, MD (mchut001@mc.duke.edu) is the Program Director of the DCRU.

In order to facilitate management of the DCRU and to maintain the quality of its contribution to medical science, a Scientific Advisory Committee is appointed on a rotating basis by the Dean of the School of Medicine, the Principal Investigator for the CTSA grant, and the Director of the DCRU. It includes a cross-section of faculty. The Duke CRU Scientific Advisory Committee is a statutory committee required by the DCRUs Branch of the NIH to make recommendations to the Director on all aspects of the Unit.  While this includes advice concerning the operation and management of the Unit and the relationship of its activities to the Medical and Hospital functions, its primary responsibility is to pass judgment on projects proposed for the use of the DCRU facilities and to review the quality and productivity of research being carried out on the Unit.

Administration

The Director of Opertions is responsible to the Program Director for proper execution of DCRU policies and unit operations. The Director of Operations is responsible for the day-to-day management of administrative matters concerning personnel, budget, and all other areas required for an accurate accounting of Center activities.

Contact:
Cathy Lavin, RN, MHA (Director of Operations) (684-3806, lavin007@mc.duke.edu)

Nursing

The mission of nursing in the Duke University Clinical Research is to provide high quality, ethical, safety-oriented, subject-centric, protocol specific nursing care for diverse populations in both inpatient and outpatient settings.  Additionally the mission includes nursing consultation, collaboration and coordination with investigators during protocol development and implementation.

General

Nurses assigned to the DCRU are Registered Nurses with at least 2 years of research nurse experience.  Currently the median experience is over 20 years in a research environment.  They are skilled in procedures common to research studies that are conducted in the outpatient and inpatient arenas as well as those focused on adult and pediatric populations.  The nursing team (n=15) is currently divided into work teams that are addressing:

  • Research conducted in Duke South (Rankin Unit)
  • Staff education
  • Staffing
  • Scheduling of subject/patients

Administration

The nursing team is headed by a director of clinical operations assisted by an interim nurse work team leaders for DCRU North Pavilion, an interim nurse work team leader for Rankin Unit, and a nurse educator.

Work of the Unit(s)

The DCRU nurses work with investigator/industry throughout the processing of placing and conducting a study at the DCRU.  Specifically they will:

  • Meet with investigators to discuss the resources of the DCRU and tour the facilities
  • Work with the investigator to insure a match with the investigator needs and the nursing resources of the DCRU
  • Assist with the application process and development of study plans
  • Participate in the interdisciplinary review of the protocol
  • Schedule and participate in a protocol presentation conference for the staff of the DCRU
  • Conduct the study according to study plans- identify and report adverse events or protocol deviations
  • Assess, suggest and implement methods to improve study efficiency
  • Assign a nurse liaison to each study for problem solving, coordination and communication
  • Assist with scheduling subjects/patients to meet the recruitment goals

Education of Study Coordinators

DCRU nursing will host a series of education sessions (online modules available 24/7) combined with practical experiences that will serve as the foundation for educating and preparing new study coordinators.

Contacts:
Eugenia Johnson, R.N. (Nurse Manager) (eugenia.johnson@duke.edu)
Wendy Brown, R.N. (Nurse Clinician) (brown009@mc.duke.edu)

Office Phone: 684-2551, 684-2554.

Informatics
  • Develop Database for the collection of information.
    • For information retension and retrieval
    • MS Access is the most common local database, but other application can be used.
  • Analyze the use of computers for the progress of the protocol.
  • Find computer resources for use on the Unit for the protocol.

Bionutrition

The Bionutrition core offers specialized nutrition services to DCRU approved protocols.  Our staff is trained to monitor and maintain detailed nutrition parameters that impact the overall design of the research study.

Our Metabolic Kitchen provides research subjects with meals scheduled and prepared in accordance with specific protocols. The kitchen offers a meal service unique to the DCRU that includes regular diets as well as research diets .

In addition to the metabolic kitchen, our Bionutrition core offers a variety of clinical nutrition services.  Clinical services include nutrition assessment, nutrient analysis, anthropometric measurements and assistance planning nutrition components of new protocols.

The services available through our unit include but are not limited to the following:

Metabolic Kitchen

  • Regular meals during subject admissions and clinic visits (when specified in protocol)
  • Research Diets
  • Controlled feeding studies
  • Infant formula preparation

Clinical Nutrition Services

  • Nutrition Assessment
  • Subject Diet Instruction
  • Nutrient Intake Assessment (24 hour diet recall, food diaries, food frequency questionnaire, etc)
  • Computer Analysis of Nutrient Intake (Nutrition Data System for Research)
  • Design assistance for nutrition component of protocols
  • Anthropometric measurement (skinfold measures, circumference measures, etc)
  • Bioelectrical Impedance Analysis (BIA) to assess body composition
  • Education of dietetic interns

Contacts:
Susan Rohn (Bionutrition Manager) (rohn0001@mc.duke.edu) Phone: 668-2251
Ann Blankenship Clark (Dietitian) (ann.clark@duke.edu) Phone: 668-2250

Biostatistician

Dr. Shein Chow, Assistant Professor in the Department of Biostatistics and Bioinformatics provides biostatistical support services to DCRU investigators. Dr. Chow’s primary expertise is in the design and analysis of clinical trials.

Contact:
Shein Chow, Ph.D. (Biostatistician) ( u)

Sample Processing Laboratory


Staff:
  1. Medical Technologist, Senior
  2. Certified Phlebotomists - 2

Hours of Operation: Other hours as needed
  1. Monday thru Friday
  2. 7:00 AM - 4:30 PM

Types of Samples Processed:
  1. Whole blood
  2. Serum
  3. Various types of plasma
  4. Urines - spot and timed collections
  5. Other fluids - saliva, seminal, and synovial

Types of Processing – Examples:
  1. Multiple tube aliquoting
  2. Fixed volume aliquoting
  3. Buffy coat recovery

Equipment:
  1. Jouan Centrifuge CR312 x 2
  2. Jouan Centrifuges CR412
    1. Centrifugation - up to 3500 rpm’s per minute
    2. Controlled Temperature Centrifugation, 0 - 40 degrees C.
  3. Nikon Microscope

Sample Storage - Short-Term:
  1. Available for most protocols but space may be limited dependent upon utilization.

Types of Storage:
  1. Refrigeration
  2. Room temperature
  3. Freezer -20, -35, and -80º C*
  4. Liquid Nitrogen – 20 l storage tank – Short Term Only
    5. *Both –35º and –80º freezers are on Emergency Power Back-up Systems

Security of Samples:
  1. All samples processed for storage in the laboratory are Bar-Coded with a unique identifier number.

Documentation:
  1. General Sample Logs or individually designed protocol worksheets are completed for all samples processed in the laboratory.
  2. Sample information from logs or worksheets is entered in the secured Sample Record Database as individual Bar-Codes are generated.
  3. Information from the Sample Record Database is used to generate excel files for investigators upon request for sample transfer. The assigned Bar-Code number and all information attached to this number make up the excel file.
  4. Excel files generated are used to confirm all recorded information and cross-reference each sample prior to transfer by the investigator. Only individuals authorized in writing by the Investigator are allowed to transfer samples and/or be sent the excel file.

Research Subject Advocate

 Resources:
  1. RSA can serve as an unbiased observer during the consent process when requested by either the patient/volunteer or investigator.
  2. RSA is available to help investigators in developing data and safety monitoring plans (DSMP).
  3. RSA is available to facilitate the reporting of serious adverse events (SAE) to the DCRU Data Safety Monitoring Committee and other regulatory agencies.
  4. RSA can provide training for current good manufacturing practices (cGMP), current good clinical practices (cGCP), and current good tissue practices (cGTP).
  5. RSA can help investigators develop Standard Operating Procedures for their processes, equipment, and facilities.
  6. RSA can help investigators in resolving regulatory issues.
  7. RSA will ensure that all DSMPs are being properly followed.
  8. RSA will ensure that DSMPs for all of the IRB-approved protocols are being followed.
  9. RSA will assure that all studies are performed in accordance with the IRB-approved protocol.
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