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 & Protocol Development, formerly known as Clinical Trial Design, 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 on 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 design and template by the completion of the course.

Session dates

Throughout the course, course participants will attend six mandatory virtual sessions:

  • Orientation Session: March 30, 2022, 9am – 12pm
  • Biostatistical Consultations: April 13, 2022, 9am – 12pm
  • Biostatistical Consultations: April 27, 2022, 9am – 12pm
  • IRB & Ethics Workshop Day: May 4, 2022, 9am – 12pm
  • Biostatistical Consultations: May 18, 2022, 9am – 12pm
  • Final Oral Presentations: May 25, 2022, 9am – 12pm

Estimated time over 9 weeks:
Online: 8 hours
Virtual: 18 hours

Time commitment

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

Application due

Monday, March 7, 2022


Harvard-affiliated fellows and junior faculty (1) with a research question in the early or mid-stages of study design, and (2) planning to develop a protocol, and seeking personalized biostatistics guidance.

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

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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 process will open November 8, 2021.