Course Goals

  • Understand the components necessary to design a clinical trial
  • Understand the importance of working with statistics from conception to publication
  • Appreciate the elements of an effective IRB proposal
  • Understand how to implement a protocol
  • Know how to communicate your clinical trial design protocol in an oral presentation

How to Design a Clinical Study: Principles and Protocol Development is an opportunity for new clinical investigators who have an idea for the development of a clinical trial to participate in an intensive nine-week course. Participants will learn the fundamentals of clinical trial design, including instructions on how to design a protocol, information on IRB and regulatory topics, and trial implementation. Additional course topics include statistical analysis, budgeting, and data management.

Course faculty, including biostatisticians, will provide personalized guidance to participants in creating a complete protocol suitable for submission to an IRB by the completion of the course. Participants will also engage in peer-to-peer learning, working in small groups to provide and receive feedback on protocols under development. At the conclusion of the course, each participant will deliver an oral presentation about their prepared protocol.

Throughout the course, course participants will attend six virtual live sessions in small groups of their colleagues and a statistician. These sessions will place an emphasis on peer-to-peer learning, engagement, and collaboration as participants discuss their research and progress throughout the course.

Application due

Applications are due no later than February 28, 2024 at 5pm EST.

Session dates

All virtual live sessions will be held 9am – 12pm EST via Zoom.

Orientation Session – March 27, 2024

Biostatistical consultation – April 10, 2024

Biostatistical consultation – April 24, 2024

IRB and Ethics Workshop – May 1, 2024

Biostatistical consultation – May 8, 2024

Final Presentations – May 15, 2024


Time commitment

A combination of on-demand videos and live virtual coursework over nine weeks with six mandatory meetings.

Estimated time over nine weeks:

Online: 8 hours

Virtual: 18 hours


Harvard affiliated graduate students, fellows, and junior faculty (1) with a research question in the early or mid-stages of study design, and (2) seeking personalized biostatistics guidance in a peer learning environment.

This course may not be suitable for you if you already have a completed, approved research protocol and/or are primarily seeking biostatistical consulting or comprehensive training in applied biostatistics.

We believe that the research community is strengthened by understanding how a number of factors including gender identity, sexual orientation, race and ethnicity, socioeconomic status, culture, religion, national origin, language, disability, and age shape the environment in which we live and work, affect each of our personal identities, and impacts all areas of human health.



Free for Harvard-affiliated institutions

Cancellation and Refund Policy [PDF]

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Accreditation Statement

The Harvard Catalyst Education Program is accredited by the Massachusetts Medical Society to provide continuing medical education for physicians.

Harvard Catalyst Education Program’s policy requires full participation and the completion of all activity surveys to be eligible for CME credit; no partial credit is allowed.


The application period will begin on November 6, 2023.