What you'll learn

  • Understand and apply the foundational concepts of biostatistics and epidemiology

  • Develop a research question and formulate a testable hypothesis

  • Design and begin to implement a clinical research study

  • Cultivate the skills required to present a clinical research study

  • Critically evaluate the research findings in medical literature

  • Synthesize crucial statistical analyses using Stata software

Course description

The Foundations of Clinical Research program is rooted in the belief that clinical research training is critical to professional development in health care. Clinical research training not only creates potential independent investigators, but also enables clinicians to advance their careers through a greater understanding of research evidence. Designed to provide learners with the foundational knowledge and skill sets required to produce high-quality clinical research, our program will lay the fundamental groundwork in epidemiology and biostatistics required for a multifaceted career in clinical research.

The overarching goal of the Foundations of Clinical Research program is to equip the next generation of researchers with the skill sets essential to evaluating evidence, understanding biostatistics, and beginning their clinical research careers. Our aim is to ensure that learners develop a strong foundation in the design, implementation, analysis and interpretation of clinical research studies.

During the program, our innovative active learning approach emphasizes the traditional tutorial system with weekly live video tutorials, seminars and symposia anchored by 3 live intense weekend online workshops.  The Foundations of Clinical Research program’s six-month online curriculum emphasizes real-time skill-based learning. 

Participants will be eligible for Associate Alumni status upon successful completion of the program. Early tuition and need-based tuition reductions may be available.

Course Outline

Live Workshops

The interactive workshop curriculum will focus on hands-on skill development through active learning. To that end, the intensive schedule is designed to accelerate the growth of high-yield clinical research skills via individual and team-based workshop exercises. Students will be immersed in a dynamic learning environment that encourages collaboration and collegial networking with faculty and peers. 

Essential elements of the workshop include instruction and practical exercises in the core concepts of biostatistics, epidemiology and research question development, as well as critical assessment of the medical literature and practical training in statistical software using real-life datasets. In addition to providing training in mentorship, academic career development and leadership, we create a supportive and active learning environment where opportunities for knowledge retention and networking abound.

Live Symposia, Tutorials and Seminars

Symposia, tutorials and seminars are mandatory and will be delivered live online and organized according to eight specific clinical research topics. 

Eight 3-Hour Symposia

  • Instruction on a specific clinical research topic (e.g., cohort study design and interpretation)
  • In-depth discussion on a related epidemiology concept (e.g., odds ratio)
  • Hands-on guidance for implementing the related analysis with statistical programming in Stata

Eight 1-Hour Tutorials

  • Interpret and report on papers related to the specific clinical research topic

Eight 1-Hour Special-Topic Seminars

  • The biostatistical and epidemiological concepts to specific clinical research topics with concrete examples


All students will be expected to complete all assignments by the due dates. Assignments will be graded as either “pass” or “fail.”

Individual Assignment 1

Individual Research Question and Study Design

  • Generate a novel research question in the evidence-based PICO format
  • Receive expert faculty review

Individual Assignment 2

Design, Implement and Present an Original Abstract

  • Design and implement a clinical research study based on a publicly available dataset
  • Analyze and create data visualizations via a user-friendly R Shiny web app
  • Write a formal 350-word abstract suitable for submission to an international conference
  • Present a digital poster to faculty at Workshop 3

Online Lectures

Research Study Introduction 

  • Designing a Clinical Research Study I–III
  • Introduction to Evidence-Based Medicine, Systematic Review and Meta-Analysis
  • Study Design 1 – Observational
  • Study Design 2 – Randomized Controlled Trials
  • Study Design 3 – Quasi-Experimental Studies
  • Introduction to Biostatistics
  • An Investigator’s Responsibility for Protection of Research Subjects
  • How to Search PubMed
  • Overview of Evidence-Based Medicine

Statistical Programming in Stata

  • Loading Data
  • Basic Programming Commands
  • Data Cleansing
  • Data Analytics I – Central Tendency
  • Data Analytics II – Statistical Testing
  • Data Analytics III – Regression Testing


Director of Innovation in Surgical Education, Brigham and Women’s Hospital; Instructor in Surgery, Harvard Medical School
Research Scientist, Center for Health Decision Science, Harvard T.H. Chan School of Public Health

You may also like


Learning about the process of clinical drug development has important implications for anyone working in health care and related sectors.

Registration Deadline