The Tufts Clinical and Translational Science Institute (CTSI) is responsible for CTRC business management, including operations, personnel, research administration, facilities, and finance. The CTRC Manager reports to the Tufts CTSI Executive Director and works with the Director of Clinical Research Operations and the Scientific Director to manage the Center. Nurses and a medical assistant are available to work with principal investigators and their staff, and a study coordinator is available to assist with clinical trials in the CTRC or in the investigator’s clinic or research area.
The CTRC offers:
- Administrative services
- Nursing and Technician services
- Study Coordinator services
- Core Laboratory services
To access CTRC services and facilities, please complete a service request form.
View CTRC services and facilities.
CTRC administrative services include:
- Assistance with administrative aspects of grant preparation, protocol submission, and budget development
- Assessment of uses of CTRC resources, responding to the needs of the clinical and translational research community
- Oversight of CTRC databases used for tracking participant visits, admissions, and use of ancillary services funded by the CTRC
- Oversight of CTRC databases used for tracking participant visits, admissions and the utilization of ancillary services funded by the CTRC
- Billing investigators for ancillary expenditures and miscellaneous services
- Facilitation of the protocol review process, from submission through IRB approval.
The RN assigned to a specific protocol performs study preparation procedures including:
- Meeting with the principal investigator and study staff to ensure full understanding of the protocol, including regulatory components, and to plan for efficient and appropriate implementation of study procedures, including informed consent forms, data collection forms, study flow sheets, physician order sheets, and protocols for standardization of procedures.
- Educating other CTRC staff about protocol procedures and integrity
- Collaborating with other relevant centers and institutes for successful study preparation and conduct.
- Clinical research nurses perform study-specific procedures including:
- Instruction of study participants in specific protocol-related procedures
- 12-lead ECG tracings.
- Venipuncture for single blood drawings.
- IV placement for infusions.
- IV placement for serial timed blood drawings
- Biological specimen collection, processing and short-term storage.
- Data collection and documentation, according to protocol-specific procedures.
- Protocol-specific and general (physiological and psychological) monitoring of participants throughout the study.
- Administration of investigational medications and monitoring for response, including adverse events.
- Additional nursing and technical services as needed by specific protocols.
Research study coordinators perform services including:
- Assisting Principal Investigators with completing CTRC/Core Laboratory Request for Service applications
- Regulatory support
- Screening and enrollment of participants and obtaining Informed consent
- Administering of research questionnaires
- Data collection
- Data entry
- Assistance with reporting of adverse events
- Writing of reports (regulatory, agency-related).
The Clinical and Translational Research Center (CTRC) Core Laboratory fosters clinical and translational research by providing laboratory services and expertise to a broad spectrum of investigators, especially clinicians without access to laboratory space or personnel.
The CTRC is available for research studies 24 hours a day, seven days a week.
The Clinical Research Unit occupies 6,800 square feet on Farnsworth 6 at Tufts Medical Center and includes:
- Waiting area for research participants
- Nursing station
- Two phlebotomy chairs
- Eight private rooms [five single-bed, three double-bed) for outpatient or inpatient studies. These are general-purpose rooms that can be used for examination, specialized procedures (e.g. intravenous glucose tolerance test) or interviews. All rooms have private restrooms and all but one have a private shower.
- Administrative offices
- Desktop computers to be used by research coordinators
- Conference area for up to eight people
- Lounge for staff
- Specimen processing area
- Short- and long-term sample storage area with -20oC freezers
- Short- and long-term sample storage area with -80oC freezers
- A densitometry suite is on the same floor and houses the Hologic Model, Discovery Dual Energy X-ray Absorptiometry (DXA) machine for measurement of bone density and/or body composition. This equipment is supported through the NIH-funded Boston Obesity and Nutrition Research Center (BONRC).
- The Core Laboratory occupies 1,300 square feet on Ziskind 7 at Tufts Medical Center. Equipment and facilities include:
- Infinite M200Pro Plate Reader
- Applied Biosystems 7900HT Real-Time PCR System
- Applied Biosystems OpenArray Real-Time PCR System
- Luminex 200 Multiplex Platform
- Laminar Flow and Fume Hoods
- Centrifuges, incubators, and water baths
- TECAN Freedom EVO liquid handling system
- Bench space
- Five -80oC freezers.
Tufts CTSI is supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UL1TR001064. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Please cite this grant any time you use Tufts CTSI resources, services, and facilities.