“The Clinical and Translational Research Center is your one-stop shop for conducting a clinical study. We provide industry and non-industry clinical trial support across the full patient lifespan, and ensure a positive experience for everyone involved.”
Ronald D. Perrone, MDScientific Director, CTRC
Tufts CTSI Clinical Study Centers include the Tufts Clinical and Translational Research Center (CTRC), Tufts Human Nutrition Research Center on Aging (HNRCA), Metabolic Research Unit (MRU), and the Massachusetts Institute of Technology (MIT) Clinical Research Center (CRC).
The CTRC supports high-quality, innovative clinical research across Tufts CTSI partners and collaborators. This includes services at outpatient or inpatient facilities at Tufts Medical Center, 24 hours a day, and across other locations of care as a “CTRC without walls.”
Overseen by its Scientific Director, the CTRC provides you with the infrastructure to conduct state-of-the-art clinical trials in neonatal, pediatric, adult, and geriatric research participants in the outpatient or inpatient setting and offers resources to facilitate clinical research for studying the causes and progression of human disease and for translation of biomedical research to prevent, treat, or cure disease.
Who is eligible?
All CTRC and lab services are available to research teams that include a Tufts investigator or co-investigator. These services are offered for a fee.
The CTRC is staffed by:
- Specialized research nurses
- Research study coordinators
- Administrative coordinator
The CTRC provides broad study oversight. Study coordinators are well-trained, have the required CITI, GCP and IATA certification, and collect blood samples via venipuncture.
Our services from study start to study completion follow regulatory and sponsor requirements and guidance, These include:
- Pre-site qualification activities: Completing feasibility questionnaires or surveys, preparing for and setting up pre-site qualification visits, and discussing study logistics and workflow
- Post-site selection activities: Completing regulatory package and IRB submission (local Tufts IRB, Central IRB, smart or single IRB), including initial and continuing reviews
- Preparing for and conducting site initiation visits
- Budget preparation and negotiation
- Preparation of study source documents and screening and enrollment logs
- Creating and maintaining study binders
- Participant screening and recruitment
- Participant consent
- Participant follow-up activities
- Liaising with the research pharmacy: Setting up study blinding and randomizing activities
- Liasing with local lab: Setting up requisition forms for specific study requirements
- Investigational study drug administration: Infusions, intramuscular or subcutaneous injections, oral drug administration, inhalation drug administrations
- Sample collection: Via venipuncture and IV line
- Sample processing and shipment
- Setting up REDCap databases for studies
- Data collection and data entry
- Safety reporting to sponsor and IRB
- Conducting monitoring visits and follow-up
- Long- and short-term study sample storage and archiving
- Study close-out activities
Our other specific services include:
- Protocol design and writing
- Preparing documents for IRB submission: writing Informed consent, scripts for phone calls, and other documents
- Preparing regulatory documents: FDA form 1572, financial disclosure form
- Budget preparation and negotiation
- Investigational drug and device studies
- Investigator-initiated studies: Set up, help with study design, logistics, and workflow assessments
- Research participant recruitment advertising follow-up activities
- Investigational drug administration
- Sample collection and processing
- Long- and short-term sample storage and archiving
- Creating and maintaining REDCap databases
- Data collection
- Safety reporting for adverse events, serious adverse events
Facilities available on Floating 6 and Ziskind 7 at Tufts Medical Center include:
- Waiting area for research participants
- Nursing station
- 1 phlebotomy chair
- 3 private rooms that can be used 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.
- Administrative offices
- Areas equipped with desktop computers to be used by research coordinators
- Conference area that can accommodate up to 4 persons
- Specimen processing area
- Short-term sample storage area with -20°C freezers
- Long-term sample storage area with -80°C freezers
Staff members work with investigators to provide the most appropriate and cost-effective services to meet their research needs. To get started, submit a request form.
To contact us, please submit a service request.
To contact the Research Participant Advocate, please call 617-627-4255.
Ronald D. Perrone, MD, Scientific Director
Yoav Golan, MD, MS, FIDSA, Associate Director
Vidya Iyer, MD, CPI, Manager