Boston University’s General Clinical Research Unit (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. Most recently, services have been added including pivoting operations and staffing to support COVID-19 related trials. As we continue to face the pandemic, and in concert with greater CTSI visioning, we believe that providing a clear scope of services and roles for the GCRU in the future will be beneficial. Specifically, our hope is that this vision will provide a forward looking plan for continuing to support all investigators, and establishing and clarifying how CTSI efforts can work in concert with BMC, such that the research services are synergistic and allow for expansion of high-quality, rigorous research for in-patients and COVID-related studies in the GCRU.
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.
Apply to Use the GCRU & Scheduling
Apply to conduct a study at the GCRU
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 prior to scheduling participant visits. 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.
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.
- Scheduling of research participant visits
- Organizing study implementation meetings
- Participant greeting and information intake
- Monitoring & assignment of space required for participant visits
- Ensuring space is ready for participant visit following study specific and regulatory requirements
- Initiating GCRU communication (calls and related emails) with internal and external BU/BMC stakeholders
- Purchasing of lab and study supplies
Providing GCRU tours for potential future users
Research Navigator Team & Research Job Connection
To facilitate rapid study start up and continuation, Research Navigators are available to be embedded into study teams, under the supervision of the PI and Project Manager, to provide support to include the following services: Assistance with IRB application submissions and the annual IRB review
- Screening/recruitment/retention assistance to include serving as COVID Research Liaison; informed consent; 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
Research Job Connection (RJC)
If you are looking for temporary research staff to help with your clinical or epidemiology study please visit the BU CTSI’s Research Job Connection (RJC). The 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.
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.
Clinical Implementation Team
Investigators and study teams can choose to use the GCRU facility located on the Medical Campus or if not physically practical, services can be provided through the “GCRU Without Walls”.
- Nursing to include clinical oversight of protocols, including those requiring medical procedures such as infusions/injections, biopsies, bone densitometry, etc.
- Clinical Practice Assistants who collect biosamples under the oversight of the GCRU nurse
- Protocol Review & Approval
- Invoicing & Expense Tracking
- Pre and Post award budget support for study teams
- Training of Staff and Clinical Professionals
- Management and oversight of the Research Job Connection
- Specimen handling & processing
- Biorepository inventory management
- Lab Purchasing
- Sample packaging and shipping, following study specific protocols and BU and BMC regulations
- Regulatory compliance &adherence to BU and BMC regulations
- Serves as informational resource before and during study implementation process
- Lab safety procedures
Laboratory & clinical Equipment Maintenance
COVID Implementation Team
- Nursing support to include: Infusion/injections & clinical oversight of all protocols
- Phlebotomy, vital signs, swabs & saliva collection
- Sample collection & labeling following specific protocol and BU and BMC guidelines
- Assistance with processing, packaging & storage of lab samples
- Working closely with study specific teams, assist in the consent process
- Conduct study interviews and scheduling of future participant fellows for study follow up
- Velos; RedCap; iMedidata, etc.)
- Data Entry
- Protocol Censes to ensure adherence to study specific visit requirements based on established protocols
- Visit and study specific data entry, ensures study specific protocols are followed and works with study and Implementation Team to correct errors or fix missing data elements
- Velos data entry and reconciliation to ensure correct participant billing for services provided by the GCRU and billing within BMC
- Review of study specific study visits and invoicing for services provided by the GCRU
- Review of participant/Visit Labels to ensure compliance with study specific protocols
The GCRU offers training for health professionals, including CPR certification and Phlebotomy training, and/or national certification.
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.