General Clinical Research Unit (GCRU)

Overview

Facilities

Nursing

Laboratory

Dental Clinical Research Outpatient Facility

Specialized Equipment

Fee Structure

Scheduling

Locations/Contacts

Overview

The General Clinical Research Unit (GCRU) at the Boston University Clinical & Translational Science Institute (CTSI) 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 a large number of active protocols, it is also part of a national network of 62 academic medical institutions across the country 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, prior to requesting funding. Experienced medical professionals help by facilitating the day-to-day research activities for physicians, trainees and subjects. The GCRU boasts a highly trained research staff of 8 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
  • Tanning bed
  • Children’s play area
  • NEW bone densitometry with fat distribution analysis
  • Investigator and Coordinator station
  • Extreme CT scan
  • Private outpatient rooms
  • Videotapinig laboratories
  • Kitchen and dining area
  • Treadmill
  • Private interview and consultation rooms
  • Exam rooms
  • Laboratory
  • Conference room

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 Per-Diem nurses and certified medical assistants 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
  • Fat and Muscle biopsies
  • Research methodologies
  • IM/SC injection administration
  • IV administration
  • Medication Teaching
  • EKG
  • Bone Densitometry
  • PK sampling
  • CT scan of the Extremities
  • Lumbar Punctures
  • Performing pharmacokinetic drug studies

Laboratory         TOP

The laboratory on the GCRU is staffed with an experienced Laboratory Manager and Laboratory Assistant with years of experience in laboratory services and over 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
  • Timers and large patient mirrors
  • A centralized database
  • Ultrasonic systems (25,000 mh/sec)
  • A ten-chair conference room with audio-visual equipment
  • High and low-speed hand pieces
  • A patient reception area
  • 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.

General Clinical Research Unit (GCRU) Rates        TOP

Due to new regulations that do not allow CTSA funds to pay for staff working on research protocols, effective as of July 1, 2015 the GCRU is implementing a new fee structure. Services provided by the GCRU will no longer be subsidized by the CTSA grant and will need to be paid from relevant grants or contracts.
Separate rates have been established for Investigator-Initiated Protocols (NIH, DoD, private foundation, etc.) and for Industry-Sponsored Protocols. Please see below for a full list of rates.

General Clinical Research Unit (GCRU) Rates

Nursing Responsibilities and Pricing Effective as of July 1, 2015
Phlebotomy:  Investigator-Initiated Protocols: $15 & Industry-Sponsored Protocols: $25

  • Blood Draw, Urine
Nursing Level 1
Investigator-Initiated Protocols:
$64

Industry-Sponsored Protocols:
$107
Nursing Level 2
Investigator-Initiated Protocols:
$104

Industry-Sponsored Protocols:
$174
Nursing Level 3
Investigator-Initiated Protocols:
$179

Industry-Sponsored Protocols:
$299
Nursing Level 4
Investigator-Initiated Protocols:
$458

Industry-Sponsored Protocols:
$765
Nursing Level 5
Investigator-Initiated Protocols: $720
Industry-Sponsored Protocols: $1202
  • Brief Study Visit, Simple Initial Visit or Follow-Up
  • Minimal Set-Up
  • Vital Signs, Height, Weight
  • Medication Pick-Up
  • 12-Lead EKG (1)
  • Standard Intervention, Screening or Follow-Up
  • Routine Set-Up
  • Vital Signs, Height, Weight, Anthropometrics
  • Vital Signs with Doppler
  • EKG at Multiple Time Points
  • DEXA OR CT Scan
  • IV Placement
  • Subject Medication, Monitoring and Education
  • Complex Intervention
  • Infusion <6 Hours
  • PKs up to 4 Time Points
  • Complex Set-Up Required
  • Biopsy (Fat, Muscle)
  • Lumbar Puncture
  • Glucose Tolerance Test
  • DEXA AND CT Scan
  • Intensive Intervention
  • Infusion >6 Hours
  • PKs Greater than 4 Time Points
  • Complex Sampling and Monitoring Schedule
  • Procedures Requiring Multiple Nurses
Visit Requiring Nursing in Excess of 8 Hours
Laboratory
Lab 1
Investigator-Initiated Protocols:
$11

Industry-Sponsored Protocols:
$18
Lab 2
Investigator-Initiated Protocols:
$22

Industry-Sponsored Protocols:
$37
Lab 3
Investigator-Initiated Protocols:
$40

Industry-Sponsored Protocols:
$67
Lab 4
Investigator-Initiated Protocols:
$60

Industry-Sponsored Protocols:
$100
Lab 5
Investigator-Initiated Protocols: $120
Industry-Sponsored Protocols: $200
Specimen Handling with No or Minimum Processing Specimen Processing of 15 – 45
Minutes
Specimen Processing of 45 – 75 Minutes Specimen Processing of 75 – 105 Minutes Specimen of Processing >Over 105 Minutes
Administrative
Implementation
Investigator-Initiated Protocols: $300
Industry-Sponsored Protocols: $400
Note: One-time only fee
Registration & Scheduling
Investigator-Initiated Protocols: $17
Industry-Sponsored Protocols: $28
Note: Per visit
Application, Review and Consultation, Meetings                                                            Opening of Accounts, Tutorials, Data Entry, Reports

Applications to use the GCRU indicates a commitment and agreement to financially support the fee for service policy

In the past, we have made individual exceptions exempting an investigator from GCRU charges for services, typically because the NIH or non-federal grant budget supporting the project was already in place and did not include funds for GCRU costs. Unfortunately, such exceptions will not be possible going forward as the new regulations prohibit the CTSI from subsidizing research activities with NIH CTSA funds. However, there might be the possibility of using CTSA funds to provide vouchers for GCRU services to unfunded junior investigators initiating pilot studies. Please contact the GCRU administration for more details or with questions.

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

Application is required for use of any GCRU location, i.e. Dental, Evans 8 or Pediatrics.

The application may be found here: GCRU Application

Protocols requesting use of Evans 8 facilities:

Provide 2 copies of the following materials:

  • Completed & Signed Copies of the GCRU application
  • Copies of the IRB or WIRB Letter of Approval
  • Copies of the IRB or WIRB Application
  • Copies of all Consent Forms
  • Copies of the Sponsor Protocol

Please include copies of the Investigator Drug Brochure (if applicable). Applications will not be processed without IRB or WIRB approval and E-mailed applications will not be accepted.

Applications are reviewed and approved as soon as possible after receipt. A letter of approval will be issued with forms and instructions for implementation.

Protocols requesting use of the Dental or Pediatrics location only (studies with no visits on Evans 8):

Provide 1 copy of the following materials:

  • Completed & Signed Copy of the GCRU application
  • Copy of the IRB or WIRB Letter of Approval
  • Copy of the IRB or WIRB Application
  • Copy of all Consent Forms
  • Copy of the Sponsor Protocol
  • Copy of the Investigator Drug Brochure (if applicable)

This application submission is required to ensure all protocols are entered and tracked in the CTSI administrative systems. This also requires that your protocol coordinator reports your census (visits) monthly.

Applications may be delivered to:

Lynn Sawyer
Administrative Operations Manager
General Clinical Research Unit
Clinical & Translational Science Institute
Evans 802
617-638-8175
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.