GCRU Clinical Research

BU CTSI General Clinical Research Unit

Study Implementation & Participant Services

The BU CTSI General Clinical Research Unit (GCRU) has provided critical support to clinical studies across the campus since its inception. Located on the 8th floor of the Evans Building on the Medical Campus, the GCRU provides study implementation services within the unit and beyond through its additional outreach services “GCRU Without Walls”. Research study implementation services are provided across all BU schools and BMC.

Under the leadership of George O’Connor, MD, BU CTSI Director of Clinical Research and Ridiane Denis, BS, RN, MD, GCRU Director of Clinical Research and Operations, the GCRU provides implementation and facilitation support to study teams and valuable services to a diverse population of research participants.

Additional services, such as research coordinator support, protocol review, and study feasibility are available through the Research Navigator Team (RNT). To learn more about all the services provided by the BU CTSI or to request a service, please visit the Research Navigator Team Webpage.

We are excited to share that BMC and BU now have two (2) unified Clinical Research Units that will provide cutting-edge space in support of research across the two institutions. The unified BMC CRU and BU CTSI GCRU position our health systems to expand our clinical research portfolios through state-of-the-art spaces, skilled staffing, and a multidisciplinary approach. This collaboration aims to achieve the highest level of care in clinical research operations.

In order to serve you better and ensure that studies are conducted in a safe manner, we have developed an intake form that will be used to determine the acuity of each study, and which unit is most appropriate to implement your study.

For more details about the Clinical Research Units, including location, study transitions, costs, and decision-making processes, please refer to the CRU FAQs for Researchers below.

GCRU & BMC CRU Clinical Research Intake Process

Please complete the In-Take form to allow us to assess which unit will be best to implement your study. Should you have any questions regarding the intake process or while completing this form, please contact Ridiane Denis (GCRU) or Anh Tran (BMC CRU) for assistance. Once the intake process is complete, study teams will be provided with a link to the application based on the appropriate unit selected for study implementation.

Note: If you are conducting an Industry Initiated Clinical Trial at BMC (using BMC facilities, enrolling BMC patients, or utilizing BMC services), a Research Operations Feasibility Assessment is also required. You can access the Feasibility Assessment Form here.

The Research Operations Feasibility Assessment is not required for PI-Initiated clinical research, however, please refer to this clinical research resource tool as a study initiation guide.

Scheduling Participant Visits

Our state of the art scheduling system allows study teams to request visits for study participants based on protocol specific requirements. 

To Schedule a visit to conduct a study, please go here.

If you have any questions or need assistance, please contact Annette Hinton, Administrative & Scheduling Coordinator, at annetteh@bu.edu or 617-358-7578.

GCRU Rate Structure

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

The GCRU rate structure is based on a cost reimbursable model. Rate increases are necessary on an annual basis to ensure our costs are recovered and that we provide you with the best level customer service. 

To ensure the GCRU user community has a full understanding of any potential impact to current or future research project budgets, please find additional information and available resources below:

  • GCRU fee structure increases are effective for a 12-month period (i.e., July 1, 2025-June 30, 2026). To avoid future re-budgeting, we urge study teams to include a 3-5% rate of inflation for each year that GCRU services will be rendered. E.g. a 5-year study may only utilize GCRU services from year 1-3, so applying a 9-15% inflation to that year’s fee schedule is optimal (see budgeting example below, and link provided above for a template that you can use to develop your budget). The inflationary increase is a projection of future rates and is not guaranteed. 

Budgeting example: A study receives non-industry funding and has a service charged at $100.00 in the period of July 1, 2025 to June 30, 2026. At an annual 3% rate increase: 

  • July 2026 to June 2027, this cost is $103.00 ($100 x 1.031) 
  • July 2027 to June 2028, this cost is $106.09 ($100 x 1.032) 
  • July 2028 to June 2029, this cost is $109.27 ($100 x 1.033) 

For budget development related questions or assistance please contact Ridiane Denis @ ridianed@bu.edu

Standard Operating Procedures for Research Studies

Institutional Standard Operating Procedures (SOPs) for human subjects’ research are now available. These SOPs will guide members of the research community at BMC and BU Medical Campus that work on studies that are within a specific scope – but it should be recognized that all research teams can benefit from reviewing these for best practices. To learn more about the SOPs please click here.

GCRU Laboratory
  • Specimen handling & processing
  • Biorepository inventory management (To request Biorepository services, click here (Link will be available soon)
  • Lab Processing Training
  • Sample packaging and shipping, following study specific protocols and BU and BMC regulations
Trainings & Resources

We offer trainings for research professionals, including CPR certification, Phlebotomy training, and/or national certification.

In addition, we are available to provide on-boarding support and guidance for new study coordinators hired to provide study team support:

  • Introduction to Institutional specific systems & SOPs
  • Mentoring from other research professionals
  • Assist with identifying resources to help successfully run a clinical trial:
    • Translation services
    • Recruitment strategies
    • Trainings, etc.

For training schedules and registration, please visit GCRU Training.
To inquire about availability for additional dates, outside those requested, contact: Ridiane Denis at ridianed@bu.edu

Facilities

The GCRU provides an ideal setting for conducting outpatient research studies with facilities that include:

  • Private outpatient rooms
  • Private interview and consultation rooms
  • Investigator and Coordinator station
  • Exam rooms
  • Bone Density Facility:
  1. Hologic QDR 4500W:
    Useful in research and clinical studies, the Hologic QDR 4500W is a multiple-detector, fan-beam, dual-energy X-ray absorptiometry (DXA) bone densitometer with the functionality to conduct fat distribution analysis in adults, children, and infants. This instrument can be used to take regional and global measurements of the whole body. An advanced application of QDR technology, it can directly measure fat and skeletal mass.
  2. Xtreme CT scans:
    The SCANCO Medical AG XtremeCT is used to perform a quantitative computed tomography scan of the distal radius or distal tibia to provide measurements of volumetric bone density, which can be an aid to the physician in determining the risk of fracture.

The GCRU can also provide an inpatient setting for studies requiring overnight stays. Prior to the implementation process, considerations and accommodations must be discussed with the Director of Clinical Research and Operations, Ridiane Denis, at ridianed@bu.edu or 617-358-7558.

GCRU Newsletters
Contacts

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

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

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