Overview

Tufts Medical Center investigators are invited to apply for the Blue Star Investigator Certificate Program.

This eight-module, non-credit certificate program is designed to train new investigators in clinical research, good clinical practice, and federal and local regulatory practices. 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 online pre-work and active participation at weekly live sessions. The Fall 2021 program will run on Wednesdays from 10:00AM-noon from September 29, 2021 through November 17, 2021.

Enrollment is limited and supervisor approval is required.

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 September 17, 2021 is a required prerequisite for all accepted participants.

To apply

Please complete this short survey by Friday, May 14, 2021.

Acceptance decisions will be communicated by June 1, 2021.

Frequently Asked Questions

What is the goal of the program?

The goal of the Blue Star Investigator Certificate program is to prepare investigators at Tufts Medical Center (Tufts MC) 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.

What is the value of this certificate?

Those successfully progressing in the program will receive a certificate of completion presented by Tufts MC leadership and 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?

Tufts Medical Center Investigators at any level interested in mastering the fundamental practices of study management and conduct are welcome to apply. The curriculum has been designed to target investigators in the early stage of building their research portfolio seeking to become an independent investigator. A cohort of 10-12 learners will be recruited to participate fully in mixed didactic and hands-on exercises.  The course will facilitate and encourage ongoing peer mentoring and support after the course ends.

What do I need to do to get the certificate?

You will be expected to attend and actively participate in all eight live modules, on Wednesdays, 10:00AM-noon starting on September 29, 2021 and ending on November 17, 2021. Before most live sessions, you will be asked to complete about one hour of online pre-work. The online pre-work will be essential to inform active participation in the live session group exercises.

What are the prerequisites?

You will need to complete the CITI Biomedical Researchers training and the CITI Good Clinical Practice (GCP) training before Friday, September 17, 2021. The prerequisite work takes about 6-12 hours to complete. You will need to submit proof of CITI training completion.

What will I learn during the program?

Our curriculum covers essential steps from implementing a study protocol to 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. Additionally, you will have the opportunity to connect with a mentor who can provide ongoing guidance after you complete the Blue Star certificate program.

Course outline and time commitment

Total time will include 16 hours of live training and about one hour per week of online pre-work. You will agree to attend all sessions and acknowledge that participation data is used for reporting purposes according to the program metrics. After the program, learners will have the opportunity to participate in mock exercises to address any follow-up training needs.

Please communicate with your supervisor to arrange adequate time to complete scheduled program activities.

Fall 2021 curriculum

Module 1:  Introduction to the Blue Star Program and PI Responsibilities

In this module, participants will receive an introduction to the Blue Star Certificate Program and Tufts CTSI resources, and will learn about investigator responsibilities. During break-out groups, participants will meet with potential mentors.

Module 2: Study Protocols and Budgets

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. Participants will learn about resources available from Research Administration and the Compliance Department. During break-out groups, participants will develop a budget based on a study protocol.

Module 3: Regulatory Review

In this module, researchers will learn about IRB review and approvals, discuss how to respond to IRB comments, and hear about the role and perspectives of the IRB. Participants will have the opportunity to identify common issues found in IRB applications and formulate responses to IRB comments.

Module 4: Participant Recruitment

The goal of this module is to thoughtfully anticipate keeping research on track, and discuss how to create a recruitment strategy, screen research participants, and obtain informed consent. The module will also cover maintaining participant research records, recruitment website/promotional materials, and contracts and notifications. Participants will create a recruitment strategy in break-out groups.

Module 5: Clinical Trial Maintenance Part 1: Event reporting to IRB/FDA/sponsors

This module will practice thematic scenarios applicable to all studies. Participants will learn about major grading systems such as Common Toxicity Criteria for Adverse Events, reporting requirements per rating, dose limiting toxicity, SAE government reporting criteria, and SUSAR. Participants will adjudicate a series of AEs, SAEs, and unanticipated problems for reporting to sponsors and regulators.

Module 6:  Clinical Trial Maintenance Part 2: Managing for audit

This module will provide an overview of maintaining study documentation, assessment and monitoring, preparing for an audit and maintaining “audit readiness”. Participants will learn to spot common errors found during audits and conduct a mock audit.

Module 7:  Leadership: Team Science and Supervising the Research Team

This module will go over topics related to managing a research team – roles, responsibilities and expectations, conflict resolution, and managing workflow. In break-out groups, participants will discuss case studies illustrating research team challenges.

Module 8: Next Steps and Investigator-Initiated Studies

This module will cover necessary steps for study close-out and introduce how researchers can initiate their own studies in the future. A panel will provide feedback on study ideas from learners.

Program evaluation

If you enroll in the program, you will be asked if you are also willing to share your evaluation data as part of a research study. Participation in the research study is not required to participate in the Blue Star Program.

Contact

If you have any questions, please contact Senior Research Project Coordinator Sarah Brewer, MPH.