The GCRU provides an optimal setting for researchers across all of BU and BMC to safely conduct controlled clinical studies.
📢 Important Announcement
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 two units provide the opportunity to expand research and provides the capacity to innovate. 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 partnership with community organizations, we are committed to conducting research that continues to support and serve our diverse patient populations.
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 you 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.
Where are the research units located?
The CRU at BMC is located on the 6th floor of the Yawkey Building. The GCRU at BU CTSI is housed on the 8th floor of the Evans Building.
If I have an existing study at the GCRU, what will happen to my study?
The CRU at BMC and GCRU at BU CTSI teams are working together to transition all higher-risk studies to the new unit.If your study is impacted, you will be notified prior to the transition and provided with all necessary information.
What is the cost for CRU at BMC services?
For contracts negotiated before Jan. 1, 2025, studies will continue to be charged at the current GCRU at BU rates. Starting Jan. 1, 2025, all new studies using CRU at BMC will follow the updated pricing structure.
How is the decision made about which unit is best for my study?
If you are starting a new clinical study, please complete the
Intake Form. Clinical staff from both units will review your study and determine the best site based on protocol risk levels.
Who can I contact with further questions?
For inquiries about the CRU at BMC, contact **Anh Tran, Clinical Director** at Anh.Tran@bmc.org.
For questions about the GCRU at BU CTSI, reach out to **Ridiane Denis, Director of Clinical Research Operations** at redianed@bu.edu.
GCRU Clinical Research and Operations Services and Structure
The BU CTSI General Clinical Research Unit (GCRU) has provided critical support to clinical studies across the campus since its inception. The GCRU implemented COVID-19 related trials and provided excellent clinical support during the pandemic In line with the CTSI’s vision, we believe that providing a clear scope of services and roles for the GCRU in the future will be beneficial. Furthermore. We believe that this vision will provide a forward-looking approach to maintain support for all investigators as well as defining and elucidating how CTSI efforts can collaborate with BMC in order to create research services that are synergistic and enable the growth of rigorous, high-quality in-patient research.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”. Services are provided across all BU schools, including the CRC 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 RNT. To learn more about all the services provided by the CTSI or to request a service, please visit the Research Navigator Team Webpage.
For studies implemented through the GCRU, staff will work closely with Study Teams to provide clear information regarding the budget and specific protocol implementation procedures required to complete the studies. Requests to use the RNT in the facilitation of clinical studies will be reviewed and approved by the Senior Research Navigator and the Director of Clinical Research Operations prior to the start of each study. An agreement will be created that will outline the services to be provided by the RNT that will include a timeline, specific services that will be provided, a budget and scope of work. Each request will be assessed separately and actual services provided are determined based on specific study needs, budgets and available resources.
The GCRU has been organized into eight (8) clusters with each cluster providing specific services or resources to optimize and provide functional support for clinical research across Boston University and Boston Medical Center.
GCRU Organizational Chart
Clinical Research Intake Process for GCRU & BMC CRU Study Assessment
To enable the GCRU and BMC CRU to assess the clinical research and staffing service needs of your study, and in order to correctly assign the appropriate location to meet the safety standards and needs of our research participants, we ask that you please complete an intake form. Should you have any questions regarding the intake process or while completing this form, please contact Myriam Castagne (GCRU) or Anh Tran (BMC CRU) for assistance.
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.
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.
Scheduling Participants Visits
Our state of the art scheduling system allows study teams to request visits for study participants based on protocol specific requirements. Once applications are completed and the implementation meeting is held, members of the study team are allowed to schedule participant visits.
To Schedule a visit to conduct a study, please go here.
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, below please find additional information and available resources
GCRU fee structure increases are effective for a 12-month period (i.e., July 1, 2024-June 30, 2025). 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 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, 2024 to June 30, 2025. At an annual 3% rate increase:
July 2025 to June 2026, this cost is $103.00 ($100×1.031)
July 2026 to June 2027, this cost is $106.09 ($100×1.032)
July 2027 to June 2028, this cost is $109.27 ($100×1.033)
For budget development related questions or assistance please contact Myriam Castagne @ mycastag@bu.edu
Research Navigator Team
To facilitate rapid study start up, our Research Navigators are available to be embedded into study teams, under the supervision of the PI and Project Manager, to provide support with:
Assistance with Institutional Review Board (IRB) application submissions and annual IRB review
Screening/recruitment/retention assistance to include serving as Research Liaison; completion of informed consent process; participant visit reconciliation
Adverse Event reporting
Completion of mandatory regulatory requirements for clinical studies
Identification of resources for the timely and successful completion of research projects
Referrals to appropriate clinical research services/cores & tools
Haitian Creole and Spanish Interpretation
Haitian Creole and Spanish document Translational Services
Research Navigator Daniel Mompoint
Daniel possess a Master of Arts in International Relations and has worked in foreign affairs and diplomatic missions. He is fluent in English, French, Spanish and Haitian Creole. Daniel is a certified Language Line Solutions interpreter and translator. His experience and qualifications complements his stellar track record of recruiting a diverse group of participants for clinical trials.
Research Job Connection (RJC)
Check out the Research Job Connection (RJC) offered by the BU CTSI! Our website is intended to help you find temporary support from research experts to help with your epidemiology or clinical research study. There is a pool of research professionals from BU and BMC in our RJC network, who are looking to find and/or supplement their current roles as research assistants or coordinators.
To date we received over 72 new request from Boston Medical Center and Boston University staff and students enrolled in work-study, master’s, and medical program.
To date we have collaborated with over 21 Principal Investigators (PIs) to help connect students and staff with suitable research projects.
Connected over 26 student and staff to RJC requests, enabling us to continue fostering valuable research experience.
If you are interested in being matched with Investigators or Study Teams seeking qualified research professionals, please register here.
Standard Operating Procedures for Research Studies
Institutional Standard Operating Procedures (SOPs) for human subjects research are available and effective as of January 1st, 2023. 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. (Webcamp application is coming soon!) To inquire about availability for additional dates, outside those requested, contact: Ridiane Denis at ridianed@bu.edu or Myriam Castagne at mycastag@bu.edu.
Facilities
The GCRU is conveniently located on the BUMC in the Evans building (8th floor) at 72 East Concord Street, Boston, MA. It 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
Conference room
Bone Density Facility:
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.
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.