General Clinical Research Unit (GCRU)
The BU CTSI’s General Clinical Research Unit (GCRU), located on the 8th floor of the Evans Building on the Medical Campus, provides services within the unit and beyond through its additional outreach service “GCRU Without Walls,” across all of BU and BMC.
Under the leadership of George O’Connor, MD, BU CTSI Director of Clinical Research and Ridiane Denis, Director of Clinical Research and Operations, the GCRU provides support to study teams and valuable services to a diverse population of inpatients and outpatients, including the ability to conduct pharmacokinetic studies, infusions, PK sampling, CT scans, DXA (bone densitometry), laboratory processing and/or shipping, storage in our monitored and alarmed bio-repository, and budget review and IRB support. Additional services, such as research coordinator support, protocol review, and study feasibility, are available through the Research Navigation Team (RNT). To learn more about all the services provided by the RNT or to request a service, please visit the Research Navigator Team Webpage.
Currently, the GCRU is home to more than 80 studies, including the All of Us Research Program, Pfizer-BioNTech COVID-19 Vaccine, and the ACTIV network, which are aimed at contributing to medical breakthroughs that improve healthcare for all. The GCRU provides a web-based application and scheduling system to facilitate study implementation with the flexibility to accommodate clinical research visits – when you need them – from early morning to evening and on weekends.
GCRU Without Walls
If it is physically impractical for participants to come to the GCRU for a study visit, special arrangements can be made through “GCRU Without Walls” for GCRU staff to go to your participant to provide the requested services.
In this way, the GCRU offers essential support to non-COVID and COVID-related clinical studies implemented at Boston Medical Center, including sample collections, consenting, and other study-related needs.
COVID Implementation Team (CIT)
At the outset of the pandemic, under the guidance and mentorship of Ridiane Denis, the GCRU’s Director of Clinical Research Operations, a COVID Implementation Team (CIT) was established to provide resources and services to COVID studies outside its own setting through “GCRU Without Walls.” Under the supervision of Ycar Devis, Senior Research Assistant and CIT Clinical Practice Assistant, and Della Carter, Lab Manager, the CIT consists of highly trained clinical research and/or lab assistants, including Scarlett Salerno, Deepa Anbumani, Tori Blot, Kanika Bisht, Taylor Sa, Oltion Sina, Yeshwanth Sankranthi, Anna Gao, Amrutha Chandrasekaran, Sarvani Dhandibhotla, Saima Syed, and Sanya Thomas. The CIT’s administrative staff includes Lea Bele.
COVID-19 Studies: Services Provided by the GCRU CIT:
The GCRU has implemented 20 COVID studies to date; eight have been completed and 12 are active. And, there are more in the pipeline. From March 2020 through December 2020, our CIT provided services for over 2,200 study visits that included:
- Administrative Support: Consenting, Data Entry (Webcamp, RedCap, Velos, iMedidata), Interviews, Scheduling
- Clinical Support: Physical Assessments, Injections, Infusions, Vital Signs, Phlebotomy, Swabs: (Nasopharyngeal, Oropharyngeal), Saliva Collection
- Laboratory Support: Processing, Packaging and Shipping, Sample Storage
The GCRU CIT and BU CTSI, in collaboration with the BMC Clinical Trial Office, the Infectious Disease Divisions of the Departments of Medicine and Pediatrics, and others, provide critically-needed staff to support these clinical research activities. The CIT has worked long hours in settings entailing the personal risk of infection during the pandemic, and provide truly indispensable support to COVID studies, making clinical research at BUMC and BMC possible at the most difficult of times. The GCRU team is especially proud of BMC’s successful site performance in the Pfizer vaccine trial led by Dr. Elizabeth Barnett.
Currently, the GCRU CIT is working with Dr. Ben Linas to implement the first randomized clinical trial of an immunomodulatory therapy as part of the NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV 1) initiative. Other COVID-19 treatment trials are also ongoing at BMC, including the follow-up phase of the Pfizer trial.
Research Job Connection (RJC)
The BU CTSI’s Research Job Connection (RJC) features a pool of research professionals from across BU and BMC who are interested in working additional hours to supplement their income, or in finding a new position as a Research Coordinator or Research Assistant.
In 2020, we received 46 new applications and matched 13 participants to PIs or projects, 12 of whom were successfully hired part-time and/or full-time.
If you are interested in being matched with Investigators or Study Teams seeking qualified research professionals, please register here.
Protocol Implementation: GCRU & GCRU Without Walls
Led by: Ridiane Denis
Implemented by: Mona Lauture and Anh Tran
The GCRU Protocol Implementation Team is comprised of trained nurses, some with more than 30 years’ experience, who make complex research observations and take precise specimen collections (i.e., insulin clamp). These skilled clinicians participate in groundbreaking research and provide compassionate, quality care to study participants. The team includes full-time nurses, per-diem nurses, and certified medical assistants. GCRU nurses are certified in chemotherapy and bone densitometry, and provide the following services:
- Inserting intravenous lines
- Fat and muscle biopsies
- Research methodology
- Performing pharmacokinetic drug studies
- IM/SC injection administration
- IV administration
- Medication teaching
- Bone densitometry
- PK sampling
- CT scan of the extremities
- Lumbar punctures
GCRU Rates & GCRU Without Walls Fees
National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH), which supports the CTSI GCRU through its Clinical and Translational Science Award (CTSA) program, announced in 2014 that direct support of the clinical research units will not be allowed for any new or re-competing CTSA awards. Subsequently, 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.
- GCRU Rates:
GCRU rates have been established for investigator-initiated protocols (NIH, DoD, private foundation, etc.) and industry-sponsored protocols. See the GCRU Rates – a la Carte Menu.
- GCRU Without Walls (GWW) Fees:
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 that 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 the support of translational research.
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 firstname.lastname@example.org or 617-358-7558.
Led by: Della Carter
The GCRU laboratory is staffed with a Laboratory Manager, experienced in laboratory services and phlebotomy for pediatric and adult participants, and a Laboratory Assistant. The GCRU laboratory provides the following services:
- Specimen processing: blood, urine CSF, sputum
- Packaging and shipping (dry ice for shipping and transport)
- Storage of frozen samples with matching log
- Bio-repository services: (offers term storage of research samples to BUMC investigators)
- Informational resource before and during the implementation process
All laboratory personnel are certified in:
- Lab safety (yearly)
- Safety and infection control (yearly, online)
- Shipping biologicals (every two years)
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 and implementation, coordinators must be authorized to use the online system. The GCRU’s scheduling coordinator will send a form to the study coordinator to be completed and signed by the investigator who is allowed to authorize up to a maximum of three coordinators (IRB approved study staff) to use the online scheduling system. The study coordinator will also be provided with a printable scheduling tutorial for their reference.
Visit the CTSI scheduling system website. You will be prompted for your BU Kerberos username and password. For more information or assistance, please contact Mary Ann Ingaciola, Administrative & Scheduling Coordinator, at email@example.com or 617-358-7578.
Training Available at GCRU
The GCRU offers training for health professionals, including CPR certification and Phlebotomy training, and/or national certification.
Apply to Use the GCRU
Locations & Contacts
General Clinical Research Unit:
Ridiane Denis, RN, MD.
Director of Clinical Research Operations
GCRU Administration & Location:
Helia Morris, MSM
Evans Building, 7th Floor
72 East Concord Street
Hours: Monday to Friday, 8:30 a.m. to 4:30 p.m.