Protocol Implementation

Participant & Clinical Interactions

Individuals’ voluntary participation in research studies is a critical success factor for the research enterprise. But such participation can only be assured when research is conducted in compliance with rules and regulations and to the highest ethical standards.

CTSI is acutely aware of the public’s concerns about the safety of medical research studies, industry’s concerns about protocol compliance and completion, investigators’ complaints about burdensome regulatory and training requirements, and everyone’s concern about lack of reproducibility, and incomplete and unreported results. Consequently, we are committed to the adoption and implementation of innovative policies and infrastructure that improve the quality of human subject protections and promote a culture of responsibility, while streamlining institutional bureaucracy—and minimizing burden and delays—across all participating institutions and organizations.

To this end, CTSI has developed several strategies to ensure that investigators and their study teams are well-trained on regulatory and institutional requirements and good clinical practices (GCP). Altogether, 1300 faculty and staff researchers receive GCP training—advanced and basic—each year.

Beyond the extensive training provided, other checks are in place to ensure compliance:

  • The BU Medical Campus/Boston Medical Center IRB approves, monitors, and reviews biomedical and behavioral research involving humans and assures that each study’s design minimizes risk to subjects. The IRB review process is being streamlined to expedite the start-up of human studies while assuring the highest standards of human subject protection and research quality.
  • Our Quality Assurance (QA) Program has been developed to (1) ensure that rights and safety of human subjects are protected and (2) assure the validity and integrity of the research data. QA audits examine a number of study components including whether all team members have the required qualifications and training, the recruitment and enrollment procedures, study documentation, the completeness of the regulatory binder, whether subjects meet eligibility requirements and documentation of informed consent.
  • As some translational research data are sensitive, CTSI developed the Secure Clinical and Translational Research Network (SCTRN) to enable unstructured data to be stories in a protected area accessed only via virtual desktops. Sensitive data cannot be transferred to a location where it is subject to theft. Approved under the Federal Information Security Management Act, SCTRN ensures rigorous protection of clinical data and is available across the CTSA network.

Overview

The General Clinical Research Unit (GCRU) at CTSI provides resources to faculty at the BUMC, 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

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 participants. The GCRU boasts a highly trained research staff of eight 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 Director of Clinical Research Operations, Ridiane Denis, at Ridianed@bu.edu or call 617.358.7558.


The GCRU, located on the 8th floor of the Evans building at 72 East Concord Street in Boston, Massachusetts, is an ideal setting for outpatient research studies offering a variety of resources including:

  • Waiting room
  • Children’s play area
  • NEW bone densitometry with fat distribution analysis
  • Investigator and Coordinator station
  • Extreme CT scan
  • Private outpatient rooms
  • Videotaping laboratories
  • Kitchen and dining area
  • 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.

Nurses at the 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

The GCRU laboratory is staffed with an experienced Laboratory Manager and Laboratory Assistant with years of experience in laboratory services and phlebotomy experience combined in pediatric and adult participants. The GCRU laboratory provides the following services:

  • Processing of 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 two years)

The Dental Clinical Research Outpatient Facility is located on the 1st floor of the Dental School (100 East Newton Street, Boston, Massachusetts). The facility occupies 1,000 square feet and serves Dental School faculty. 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.

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

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


The Hologic QDR 4500W, a new bone density instrument, 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 perform 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 and allows for 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.

GCRU rates have been established for investigator-initiated protocols (NIH, DoD, private foundation, etc.) and industry-sponsored protocols. A full list of rates can be found here.

Applications to use the GCRU indicates a commitment and agreement to financially support the fee for service policy that has been established for the GCRU.

General and Clinical Research Unit Rates

The GCRU has developed separate fee structures for Investigator-Initiated studies (NIH; DoD; Private Foundations; etc. ) and for Industry Funded studies. The fee schedule includes the various levels of services provided by the GCRU per type of study.

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 five business days for review, after which time the account will be charged by internal journal entry. Fees will be reinvested in program resources to continue support of translational research.

Scheduling

The BU-CTSI web-based scheduling system allows project coordinators to request appointments for participants in studies that use the GCRU.

After approval of the study, coordinators must be authorized to use the online system. A brief (30 minute) hands-on tutorial is offered to familiarize users with the system and to answer any questions.

Visit the CTSI scheduling system website. You will be prompted for your BU Kerberos username and password. For more information, please contact Mary Ann Ingaciola, at mingacio@bu.edu.

Application

To conduct a study in the GCRU, please apply here.
GCRU Application Instructions
Billing and Scheduling Worksheet
Nursing Flowsheet
Lab Template

Locations & Contacts

George O’Connor, MD
Director Clinical Research, BU-CTSI
617.638.4470
goconnor@bu.edu
BU Profile

Ridiane Denis
Director of Clinical Research Operations
Phone: 617.358.7558
ridianed@bu.edu

Helia Morris, MSM
Executive Director
Phone: 617.358.7327
hmorris@bu.edu

Britte Beaudette-Zlatanova, Ph.D.
Clinical Research & Operations Manager
Phone: 617.358.7563
britte@bu.edu

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
Phone: 617.414.1065
Judjones@bu.edu
BU Profiles

Maria A. Kukuruzinska, Ph.D
Goldman School of Dental Medicine
Associate Dean of Research
Phone: 617.638.4859
mkukuruz@bu.edu
BU Profiles

Carol Nicholson
SDM Clinic Coordinator
Phone: 617.638.4554
carolnic@bu.edu

Administration Location

Evans Building, 7th Floor
72 East Concord Street
Phone: 617.358.7274
Fax: 617.358.7556
Hours: Monday to Friday, 8:30 am to 4:30 pm

Howard Cabral, PhD, MPH
Department of Biostatistics, BUSPH
Phone: 617.638.5010
hjcab@bu.edu
BU Profile

Joseph Palmisano, MPH
Biostatistics and Epidemiology Data Analytics Center (BEDAC), BUSPH
Phone: 617.638.5384
jpalm@bu.edu

Find more information on the Participant & Clinical Interactions faculty and staff here.