Blue Star BRIDGES
(Building Research & Innovation for Drug Effectiveness & Safety)
Overview
This five-week, free non-credit certificate program is designed to provide individuals affiliated with disease advocacy organizations or communities with foundational knowledge and skills in the development and conduct of clinical trials. The program is tailored to meet the needs of those who have some experience in clinical studies, but who have not yet been a Principal Investigator on or initiated their own study. Topics covered will include study protocols and budgets, regulatory processes, the drug development process, clinical trial conduct and audits.
The Blue Star BRIDGES Program is a blended learning experience requiring online pre-work and active participation at weekly live sessions. The live sessions will be held on Zoom, Wednesdays from 10:00AM–1:00PM EST, Wednesday, May 7–Wednesday, June 4, 2025.
Completion of the Department of Health and Human Services Human Research Protection Foundational Training OR the CITI Biomedical Research Training prior to program start is a required prerequisite for all accepted participants.
To apply
Apply here by Friday, February 28, 2025. Acceptance decisions will be communicated in mid-March.
Frequently Asked Questions
What is the goal of the program?
The goal of the Blue Star BRIDGES program is to prepare individuals to carry out responsibilities as principal investigators in accordance with federal regulations and any applicable partner requirements. This program will promote best practices for the conduct of quality research.
What is the value of this certificate?
Those successfully progressing in the program will receive a certificate of completion presented by Tufts CTSI. This institutionally recognized program will present a tangible value to prospective sponsors, mentors, or collaborators as evidence of your readiness to conduct research.
Who should enroll in the program?
Individuals interested in mastering the fundamental practices of clinical trial management and conduct are welcome to apply. The curriculum has been designed for lay leaders in advocacy organizations in the early stage of designing and implementing clinical studies. A cohort of 10-15 learners will be recruited to participate fully in mixed didactic and hands-on exercises.
What do I need to do to get the certificate?
There is no cost to participate in the program. You are expected to attend and actively participate in all five 3-hour live sessions and complete all online pre-work. The online pre-work will be essential to inform active participation in the live session group exercises. You will develop a three-minute elevator pitch for a clinical study idea related to your own interests. In addition, all participants are required to complete the final program evaluation.
What are the prerequisites?
You will need to complete the free Department of Health and Human Services Human Research Protection Foundational Training OR the CITI Biomedical Research Training for regulatory compliance before you will have access to the online pre-work. The prerequisite work takes about 5 to 6 hours to complete depending on which training you are taking. You will need to submit proof of this compliance training completion.
What will I learn during the program?
Our curriculum covers essential skills in clinical research from conceiving a study protocol to the study close-out. Whether you plan to conduct an industry-sponsored protocol, or a protocol of your own, you will be able to anticipate the series of actions expected of you for a successful execution of your study.
Course Outline and Time Commitment
Total time will include 15 hours of live training and about one hour per week of online pre-work (20 hours total). You will agree to attend all sessions and acknowledge that participation data is used for reporting purposes according to the program metrics.
Current curriculum
Module 1: Introduction to the Program and Clinical Trials
May 7, 2025
In this module, participants will receive an introduction to the Blue Star BRIDGES Program and the research pitch assignment. Participants will be introduced to the case study on repurposing an approved drug for rare disease and practice a gap analysis.
Module 2: Drug Development and Regulatory Processes
May 14, 2025
This module provides a high-level overview of the drug development process and the role of regulation in research with human participants. Topics covered include Institutional Review Board (IRB) review and approvals, common mistakes in protocols and consent forms, and ethical case studies.
Module 3: Designing and Budgeting Research Protocols
May 21, 2025
This module will identify the major components of a study protocol and a study budget, and describe the relationship between the protocol, the budget, and study feasibility. During break-out groups, participants will develop a budget based on a study protocol.
Module 4: Conducting the Study
May 28, 2025
In this module participants will learn about adverse event definitions and reporting criteria, maintaining study documentation, assessment and monitoring, preparing for an audit, and maintaining “audit readiness.” Participants will work through case examples of adverse events and will learn to spot common errors found during audits of participant files. This module will also cover topics related to managing a research team, including roles, responsibilities and expectations, and managing difficult conversations
Module 5: Pitching Your Study Idea
June 4, 2025
In this final module, participants will present a 3-minute pitch of a clinical study idea to a panel of mentors and receive feedback. The module session will conclude with a program reflection discussion.
Contact
If you have any questions, please contact Project Manager Patricia Reyes.