General Clinical Research Unit (GCRU)

General Clinical Research Unit

Overview

Facilities

Nursing

Laboratory

Dental Clinical Research Outpatient Facility

Specialized Equipment

Fee Structure

Scheduling

Locations/Contacts

Overview

The General Clinical Research Unit (GCRU) provides resources to faculty at the Boston University Medical Center, including a controlled and optimal setting for clinical investigators, career development programs, and training for health professionals. The GCRU is currently the setting for over 50 different active protocols, it is also part of a national network of 62 centers that offer infrastructure and clinical investigation resources. Examples of resources provided by the GCRU include:

  • The ability to conduct pharmacokinetic studies in a controlled environment with both adult and pediatric inpatients and outpatients
  • Resources for timed collection of specimens and other specialized testing (bone density, CT scan etc.)
  • A private environment to explore patterns of behavior
  • A primary location for the education of future physicians, scientists and nutritionists in patient-oriented research

BU CTSI offers resources to investigators in medicine and dentistry funded by various sponsors including Federal, Non-Federal and Industry, as well as those conducting innovative clinical research pilot studies before requesting funding. The GCRU also assists projects funded in whole or in part by pharmaceutical and biotechnology companies. Experienced professionals help by facilitating the day-to-day research activities for physicians, trainees and subjects. The GCRU boasts a highly trained research staff of 7 people who support inpatient and outpatient, adult and pediatric, medical and dental studies that discover the cause, progression, prevention, control and cure of human diseases.
For specifics on services available, please contact the Nurse Manager Ridiane Denis RN at Ridianed@bu.edu or call 617-414-1961.

Facilities     TOP

The General Clinical Research Unit (GCRU) located on the 8th floor of the Evans building on 72 East Concord St. in Boston MA, is an ideal setting for outpatient research studies offering a variety of resources including:

  • Waiting room
  • Children’s play area
  • Investigator and Coordinator station
  • Private outpatient rooms
  • Kitchen and dining area
  • Private interview and consultation rooms
  • Exam rooms
  • Laboratory
  • Conference room
  • Tanning bed
  • NEW bone densitometry with fat distribution analysis
  • Extreme CT scan
  • Videotaping laboratories
  • Treadmill

The GCRU also offers an inpatient setting for studies requiring overnight stays. Prior considerations and accommodations should be made with the Nurse Manager prior to the implementation process.

Nursing         TOP

Nurses at the General Clinical Research Unit (GCRU) are trained to make complex research observations and take precise specimen collections (i.e. Insulin Clamp). These skilled clinicians are able to participate in groundbreaking research, while ensuring patients receive compassionate, quality patient care.  The team also includes a certified medical assistant to assist in research methodologies.

With an average of 30 years of experience, GCRU nurses are certified in Chemotherapy, Bone Densitometry and skilled in the following:

  • Inserting intravenous lines
  • Research methodologies
  • IV Administration
  • EKG
  • PK sampling
  • Lumbar Punctures
  • Fat and Muscle biopsies
  • IM/SC injection administration
  • Medication Teaching
  • Bone Densitometry
  • CT scan of the Extremities
  • Performing pharmacokinetic drug studies

Laboratory         TOP

The laboratory on the GCRU is staffed with an experienced laboratory coordinator and laboratory assistant with years of experience in laboratory services and an average of 15 years of phlebotomy experience combined in pediatric and adult participants.

The GCRU laboratory provides the following services:

  • Processing- Blood, Urine CSF, Sputum.
  • Packaging and shipping (dry ice for shipping and transport)
  • Storage of frozen samples with matching log
  • Informational resource before and during the implementation process
  • Bio-Repository Services (offers term storage of research samples by BUMC investigators)

All laboratory personnel are certified in:

  • Lab safety (yearly)
  • Safety and Infection control (yearly, online)
  • Shipping biologicals (every 2yrs)

Dental Clinical Research Outpatient Facility         TOP

The dental clinical research outpatient facility is located on the 1st floor of the dental school at 100 East Newton Street, Boston, MA. The facility occupies 1,000 square feet and serves faculty in the dental school. The dental clinical research unit offers services that support multidisciplinary and long-term clinical studies and product trials. This state-of-the-art facility provides researchers with a centralized, controlled testing environment for oral health-related investigations.  A ten chair conference room with audio-visual equipment is available for use by investigators.

Every dental unit offers:

  • Four fully-equipped dedicated dental units
  • A centralized database
  • A ten-chair conference room with audio-visual equipment
  • A patient reception area
  • Timers and large patient mirrors
  • Ultrasonic systems (25, 000 mh/sec)
  • High and low-speed hand pieces
  • Curing lights
  • Foot and touch-pad control

 Specialized Equipment        TOP

  • DEXA bone densitometer with fat distribution analysis
  • CT Scan
  • An exercise treadmill
  • A videotaping laboratory

Bone density facility:
A new bone density instrument the Hologic QDR 4500W was purchased in 2014. It is capable of doing bone densitometry, as well as fat distribution analysis in adults, children and infants. The QDR 4500W is a multiple detector, fan-beam Dual-energy X-ray Absorptiometry (DXA) bone densitometer. Hologic QDR 4500W Instruments allow regional and global measurements of the whole body. An advanced application of QDR technology can directly measure fat and skeletal mass and is useful in research and clinical studies

Xtreme CT scans:
The SCANCO MEDICAL AG XtremeCT preform a quantitative computed tomography scan of the distal radius or distal tibia to provide measurements of volumetric bone density, which can be used as an aid to the physician in determining risk of fracture.

Treadmill - Pro-Form 505 CST (model no. PFTL60910.1)
This treadmill features a walking belt coated with high-performance lubricant. The console features 15 on board workouts as well as allowing manual operation. The treadmill’s speed and/or incline can be changed as desired. This particular model has an iFit feature that can be used if a subscription is purchased.

Observation and videotaping laboratories
Specialized areas are available for recording developmental behavior of children and adults.

Fee Structure        TOP

Service Fee
Effective June 1, 2010, a service fee of $15.00 per visit is assessed for the use of the clinical research units, on Evans 8. At present this helps to support registration and scheduling services. The current service fee structure is under review and new rates will be implemented in the Fall of 2014. Application to use the center indicates a commitment and agreement to financially support the fee for service policy. CTSI resources may be available to offset all or part of the service fee.

Unit Fees
At the time of application, costs of visits will be reviewed and an hourly rate assigned based on GCRU resources and nursing services required and funding sources. NIH-funded research and internally funded studies are exempt from unit fees and will only be assessed a per-visit service fee.  Industry-sponsored studies are not exempt. The charge for nursing services is $52.50 per hour. The Charges for the any other services will be specified prior to study initiation.  The current service fee structure is under review and new rates will be implemented in the Fall of 2014.

Method of Payment
Following receipt of an approval letter for use of the unit, investigators will be asked to submit a completed GCRU Usage Billing Form, providing an account number which will be charged for services. An invoice for services will be sent monthly to the investigator with 5 business days for review. The account will, after 5 business days, be charged by internal journal entry. Fees will be reinvested in program resources to continue support of translational research.

Scheduling          TOP

The BUCTSI web based scheduling system allows project coordinators to request appointments for participants in studies that use the General Clinical Research Unit.

After approval of the study, coordinators are given access to the web based scheduling system. Coordinators can request appointments beginning one week after the current date. Earlier dates must be scheduled directly with a CTSI scheduler or nurse manager by phone.

Visit the CTSI scheduling system website. You will be prompted for your BU Kerberos username and password.

For more information please contact Lynn Sawyer, Administrative and Operational manager, at lsawyer@bu.edu.

Application

For the application process to conduct a study in the GCRU, please click here for the GCRU Application.

Locations/Contacts          TOP

Medical Research Unit GCRU Administration
George O’Connor, MD
Director, Clinical Translational resources
BU CTSI
617-638-4470
goconnor@bu.edu
BU Profile
Helia Morris, MSM
Executive Director
Phone: 617-638-4542
hmorris@bu.edu
Ridiane Denis, RN
GCRU Nurse Manager
Boston University Medical Campus
Phone: 617-414-1961
Fax: 617-474-1969
ridianed@bu.edu
Lynn Sawyer
Administrative and Operations Manager
Phone: 617-638-8175
lsawyer@bu.edu
Dental Research Unit Administration Location
Judith A. Jones, DDS, MPH, DScD
Professor and Assistant Dean for Faculty Development
Director, Center for Clinical Research Rm. 612A
BU Henry M. Goldman School of Dental Medicine
100 East Newton St.
Boston, MA 02118
Phone: 617-414-1065
Fax: 617-414-1061
Judjones@bu.edu
Evans Building, 7th Floor
72 East Concord Street
Fax: 617-638-8890
Hours: Monday-Friday, 8:30 am to 4:30 pm
Maria A. Kukuruzinska, Ph.D
Goldman School of Dental Medicine
Associate Dean of Research
Evans 428; X-Bldg., Room 343F
Phone: 617-638-4859
mkukuruz@bu.edu
Carol Nicholson
SDM Clinic Coordinator
100 E. Newton St. Rm 107
Boston, MA 02118
Phone: 617-638-4554
carolnic@bu.edu
Biostatistics
Howard Cabral, PhD, MPH
Department of Biostatistics, BUSPH
Crosstown Center
801 Massachusetts Avenue
Boston, MA 02118
Phone: 617-638-5010
Fax: 617-638-5066
hjcab@bu.edu
BU Profile
Data Management
Christine Chaisson, MPH
Data Coordinating Center, BUSPH
Crosstown Center
801 Massachusetts Avenue
Boston, MA 02118
Phone: 617-638-5009
Fax: 617-638-5066
chaisson@bu.edu
BU Profile

These resources might include:

  • Use of clinical research units
    The Division of Clinical Research Resources offers a centralized medical clinical research outpatient unit, a dental clinical research unit and a clinical research unit at the National Emerging Infectious Diseases Laboratories.
  • Consultations and other services
     The division offers study design and biostatistics consultations, regulatory and ethics consultations, recruitment services and support for clinical research done outside clinical research units.