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Services + Facilities

Tufts Clinical and Translational Science Institute (CTSI) provides support for all human subject research (clinical studies and trials) through its Clinical and Translational Research Center (CTRC). Formerly known as the General Clinical Research Center, it has been in continuous operation since 1961.
Administrative services

CTRC administrative services include:

  • Access to CTRC space, nursing support, and specialized clinical procedures
  • Support for biospecimen collection, labeling, processing, and secure data handling
  • Help connecting with institutional resources like core facilities, biostatistics, and community engagement
  • assistance with administrative aspects of grant preparation and budget development
  • Guidance on clinical research best practices and institutional systems
  • Facilitation of the protocol review process, from submission through IRB approval
  • Assistance with IRB submissions, continuing reviews, and compliance monitoring
  • Management of CTRC databases used to track participant visits, admissions, and use of ancillary services
  • Assistance with scheduling, subject follow-up, and study documentation
Nursing and technician services

The nurse 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
Study coordinator services

Research study coordinators perform services, including:

  • Assisting Principal Investigators with recruitment
  • Liaison with CTSI's Recruitment and Retention Unit
  • Regulatory support
  • Screening and enrollment of participants and obtaining Informed consent
  • Participant follow-up
  • Administering research questionnaires
  • Data collection
  • Data entry
  • Database development
  • Adverse events reporting
  • Phlebotomy
  • Sample processing and shipment
  • Additional Services as needed by specific protocols
Facilities

The CTRC is available to support research studies. The Clinical Research Unit is located in North Building, 6th floor at Tufts Medical Center and includes:

  • Waiting area for research participants
  • Nursing station
  • Three private rooms for outpatient studies. These are general-purpose rooms that can be used for examinations, specialized procedures (e.g. intravenous glucose tolerance test) or interviews
  • Patient restroom
  • Administrative offices and conference room
  • Desktop computers to be used by research coordinators
  • Conference area for up to eight people
  • Short- and long-term sample storage area with -20oC freezers
  • Short- and long-term sample storage area with -80oC freezers

Tufts CTSI is supported by the National Center for Advancing Translational Sciences, National Institutes of Health, Award Number UM1TR004398. 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.

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