Services

Tufts CTSI aims to implement and grow innovative resources, services, and policies that support and promote collaborative, cross-disciplinary, full-spectrum translational research.

Our comprehensive research services are designed to increase:

• Research innovation and impact
• Investigator productivity
• Development of novel research methods
• Preparation and submission of multi-institution, interdisciplinary proposals
• Early-stage research projects with translational potential
• Participation of community members in clinical and translational research

Download a brochure about Tufts CTSI’s research services (PDF).

Not sure where to start? Follow these steps:

Design your study.
Initiate your study.
Conduct your study.
Close out your study.

Design your study

Develop your study idea.

• Community and Stakeholder Engagement (CSE) engages stakeholders to ensure research is relevant.
• The Biostatistics, Epidemiology, Research Study Design (BERD) Center provides epidemiological/study design and biostatistical consultations and collaborations. They can advise on primary and secondary aims to be included in Clinical Trials.gov reporting.
• The Program Evaluation Service consults and collaborates to design program evaluations, often using surveys and/or qualitative methods.
• Regulatory Knowledge and Support (RKS) services expedite protocol development by advising research teams on protocol optimization for regulatory compliance and consent requirements.
• Tufts CTSI offers assistance with Data and Safety Monitoring Board (DSMB) charter development, setup, meetings and consultations.
• The Recruitment and Retention Support Unit (RRSU) provides customized recruitment services, including advice and support to develop recruitment plans and strategies for identifying and recruiting eligible participants.
• The Tufts Office of the Vice Provost for Research (OVPR) and the Tufts CTSI Research Development Specialist assists with grant proposal development and identifying the most relevant funding mechanisms with a specific interest in the development of large multi-center grant proposals across Tufts CTSI partners.
• T.5 Capacity in Medical Devices provides consultations to support research teams spanning preclinical and T1-2 topics, including prototype design and clinical applications and regulatory and intellectual property support.

Assess study feasibility.

• Informatics provides cohort discovery services to identify potential study populations within Tufts Medicine based on inclusion/exclusion criteria.

Find collaborators.

Put in a service request for connection to the following via our Navigators:

• The Research Collaboration Team (RC Team) can assist in building research teams, connecting collaborators, and promoting sustained involvement of community members in clinical and translational science from study concept to the dissemination of results.
• Multi-site Clinical Research Center (MCRC) services include site identification for multi-site trials and consultations on the use of the central IRBs, master protocol templates, master agreements, and a Data Coordinating Center (DCC) for all affiliated investigators. Personnel from the MCRC are also available to serve as a liaison for Tufts and Tufts affiliated investigators to access additional services from the Trial Innovation Network (TIN). The TIN is a collaborative initiative within the CTSA program which works to support multi-site clinical trials.

Submit funding application.

• The Research Development Team in the Tufts University Office of the Vice Provost for Research (OVPR) and the Tufts CTSI Research Development Specialist provide grant-writing support services for faculty.
• The Research Collaboration Team (RC Team) also conducts grant advising services also known as “Research Studios” to help researchers hone their research proposals and address translational roadblocks.
• Tufts CTSI issues an annual call for the Small Grants to Advance Translational Science (S-GATS) Program, as well two voucher programs to cover fee-for-service assistance in the CTRC and Informatics.

Access other consulting services to improve study design and funding proposals.

Tufts CTSI offers expert consultations in Comparative Effectiveness Research (CER) to provide evidence for the relative benefits, harms, and resource consumption of alternative treatment strategies; One Health for interdisciplinary approaches to optimizing health at the intersection of humans, animals, and the environment; and Nutrition Intervention Research (NURISH) study designs to minimize barriers that impede the translation of human nutrition research into public policy.

Initiate your study

Apply for INDs/IDEs and Certificates of Confidentiality.

• Regulatory Knowledge and Support (RKS) assists research teams with investigational drug management requirements and serves as a resource for internal and FDA audits.
• Our Research Participant Advocate is a resource for our research community and participants throughout the research process regarding research ethics, participant rights, and research safety.

Get study approval.

• The Biostatistics, Epidemiology, Research Study Design (BERD) Center supports protocol development for Institutional Review Board (IRB) submissions.
• Regulatory Knowledge and Support (RKS) assists with regulatory compliance of research protocols being submitted to the Tufts IRB.

Train personnel.

• Professional Education offers a wide array of courses, workshops, and seminars in topics such as clinical and translational research, career development, grant writing, quality improvement, and regulatory affairs. We also offer mentoring support grants, fellowships, and a forum for junior faculty.
• Informatics offers training and consultations on the features and research uses of REDCap.

Build data collection forms.

• Tufts CTSI partners and collaborators can request access to the HIPAA-compliant REDCap, a secure web application for building and managing online surveys and databases.
• In collaboration with Biostatistics, Epidemiology, Research Study Design (BERD) Center, Informatics consulting services can recommend other approaches to data management plan development, database design, and setup of data quality checks.
• Informatics can help collect and manage research data, develop databases, and identify study participants.

Recruit participants.

• The Recruitment and Retention Support Unit (RRSU) provides customized recruitment services, including advice and support to develop recruitment plans and strategies for identifying and recruiting eligible participants
• Our Stakeholder Expert Panel (SEP) offers consulting capacity and facilitates engagement of stakeholders in research projects. 
• Regulatory Knowledge and Support (RKS) provides a spectrum of Data Safety Monitoring Board (DSMB) services, advice on generating shortened Informed Consent Forms, and advisory services to facilitate participant recruitment.

Optimize study workflow.

• Research Process Improvement (RPI) services assist research teams with study implementation and optimal study workflow.

Conduct your study

Conduct participant visits.

• The Clinical and Translational Research Center (CTRC) offers a full range of clinical trial support services, such as clinic space, nursing and coordinator staff, and services such as EKG, infusions, and phlebotomy.
• The Clinical Research Center at MIT provides services related to medical device development and testing.
• The Multi-site Clinical Research Center (MCRC) and Recruitment and Retention Support Unit (RRSU) will recruit participants into studies, and incorporate additional strategies.

Collect and access data.

• Tufts CTSI partners and collaborators can request access to the HIPAA-compliant REDCap secure web application for building and managing online surveys and databases.
• In collaboration with Biostatistics, Epidemiology, Research Study Design (BERD) Center, Informatics consulting services can recommend other approaches to data management plan development, database design, and setup of data quality checks.
• Informatics can assist with identification of common data models, common data elements, and other data standards, collection of provenance data for research reproducibility.
• The Program Evaluation Service can assist with developing and conducting surveys, interviews, and focus groups.

Submit an IRB Continuing Review and IRB Amendments.

• The Clinical and Translational Research Center (CTRC) and the Biostatistics, Epidemiology, Research Study Design (BERD) Center can assist with all types of IRB submissions.

Address any problems that arise.

• Research Process Improvement (RPI) services assist research teams with problem-solving study challenges and modifying procedures to ensure successful study completion.
• When compliance issues are identified, Research Administration and departments can refer research teams to the Regulatory Knowledge and Support (RKS) Tufts Blue Star Program for additional training and mentoring on regulatory compliance.

Close out your study

Get help with data analysis.

• Biostatistics, Epidemiology, Research Study Design (BERD) Center staff perform data cleaning and statistical analyses for the study’s aims.
• The Program Evaluation Service provides descriptive analyses of survey and qualitative data for program evaluation studies.

Publish your manuscript.

• Biostatistics, Epidemiology, Research Study Design (BERD) Center staff help research teams with writing the methods and results sections of manuscripts, and with responding to reviewer comments.
• Program Evaluation Service staff can assist with preparing visualization and dissemination materials for a range of audiences.
• All publications supported by Tufts CTSI should be submitted via the NIH Manuscript Submission System and assigned a PubMed Central ID.

Cite Tufts CTSI.

• Please help to ensure the future of clinical and translational research at Tufts. Cite the NIH CTSA award any time you use Tufts CTSI resources, services, and facilities: UM1TR004398.

Close out on ClinicalTrials.gov.

• The Biostatistics, Epidemiology, Research Study Design (BERD) Center can assist research teams with ClinicalTrials.gov reporting requirements.

Publicize your study.

• The Research Collaboration Team and Community & Stakeholder Engagement (CSE) advise research teams on dissemination of research results and strategies for communicating clinical trials results.