Overview

This accelerated version of the 10-week Blue Star certificate program is designed to train new investigators in fundamental skills required to serve as a site PI on an industry-sponsored clinical trial. The program is tailored to meet the needs of new investigators who may have previously served on a study team, but who have not yet been a PI on an industry-sponsored study or initiated their own study. Topics covered will include study protocols and budgets, regulatory processes, participant recruitment, and clinical trial maintenance.

The Blue Star Program is a blended learning experience requiring completion of online didactic pre-work and active participation at two full-day live sessions. The Fall 2025 live sessions will be held Thursday, November 13 and Friday November 14, 9:00AM–4:00PM in-person at the Tufts CTSI offices at 35 Kneeland Street, Boston.

Enrollment is limited and supervisor approval is required. Enrollment is open to faculty and fellows at Tufts Medicine, Tufts University, and other CTSI partner institutions.

Completion of the CITI Biomedical Research Training and the GCP for Clinical Trials with Investigational Drugs and Medical Devices Training (approximately 6-12 hours) prior to program start is a required regulatory compliance prerequisite for all accepted participants.

To apply

The application period has now closed.

Frequently Asked Questions

What is the goal of the program?

The goal of the Blue Star Investigator Training program is to prepare investigators at Tufts Medicine and affiliates to carry out their responsibilities as principal investigators in accordance with federal regulations and our local institutional processes. This program will promote best practices for the conduct of quality research.

Who should enroll in the program?

Faculty investigators at any level and fellows interested in mastering the fundamental practices of clinical trial management and conduct are welcome to apply. The curriculum has been designed for investigators in the early stage of building their research portfolios and seeking to serve as site PIs on industry studies. A cohort of 10-12 learners will be recruited to participate fully in mixed didactic and hands-on exercises.

What do I need to participate in the program?

All accepted participants must:

Course Outline and Time Commitment

Total time will include 14 hours of live training and completion of approximately 3 – 4 hours of online pre-work content (approx. 18 hours total). You will agree to attend both live sessions and acknowledge that participation data is used for reporting purposes according to the program metrics. All applicants will be asked to confirm that their supervisors have approved protected time to complete required program activities.

Current curriculum

Online Didactic Program Content

Module 1: Study Start-up. Covers analyzing study protocols and assessing site feasibility.

Module 2: Engaging with Participants and Stakeholders. Covers fundamentals of stakeholder engagement and recruitment and retention of study participants.

Module 3: Regulatory Review. Covers fundamentals of working with the Tufts Health Sciences Institutional Review Board.

Module 4: Adverse Event Reporting. Covers key definitions of adverse events for FDA and OHRP, adverse event classification and reporting requirements and timelines.

Module 5: Audit Readiness. Covers basics of maintaining regulatory binders, preparing for different types of audits, and maintaining audit-ready status.

Module 6: Leading and Managing Research Teams. Covers key concepts of management and leadership with clinical research settings, including team science principles and fostering psychological safety.

Module 7: Study Close-out. Covers procedures for closing industry-sponsored studies at Tufts Medicine.

Live Session Agenda

Day 1: Thursday, November 13, 2025

  • Introduction to Tufts CTSI
  • Overview of program goals and site PI responsibilities
  • Reviewing a study synopsis
  • Evaluating and implementing the protocol
  • Budgeting your study
  • Recruitment, retention, and engaging stakeholders
  • Meet the Tufts HS IRB
  • Ethics case study discussion
  • Assessing key information in ICFs

Day 2: Friday, November 14, 2025

  • Adverse event reporting exercise
  • Reviewing errors in participant files
  • Audit case study discussion
  • Audit experiences panel
  • Leading and managing research teams: The study kickoff meeting
  • Communication & conflict in research teams
  • Difficult conversations role play
  • Program evaluation and reflection discussion

Contact

If you have any questions, please contact Project Manager Patricia Reyes.