Foundations of Clinical Research

  • Certificate Program
A woman in a lab coat with her hair up working on a desktop.

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Application Deadline: August 6

Launch your clinical research career with essential training in study design, biostatistics, epidemiology, and statistical analysis. This program is designed for health care professionals with limited or no prior experience in clinical research.

  • Live Online

This program requires attendance at three live virtual workshops.

$8,900

Please see more program fee information below.

Certificate

This program offers HMS Associate Member status.

8 Months, 7-10 Hours/Week

Between workshops, you’ll engage with pre-recorded materials, live lectures, symposia, tutorials, Stata sessions, faculty-led reviews, and individual assignments.

On This Page

Overview

The primary objective of the Foundations of Clinical Research program is to prepare the next generation of researchers with the critical competencies necessary to evaluate evidence, understand and utilize biostatistics, perform statistical analyses, and embark on their clinical research careers. We strive to ensure that participants develop a robust understanding of designing, implementing, analyzing, and interpreting clinical research studies.

Workshop 1

  • September 6–7, 2025
  • Location: Live Online

Workshop 2

  • January 31–February 1, 2026
  • Location: Live Online

Workshop 3 and Graduation

  • April 25–26, 2026
  • Location: Live Online

Learning Objectives

  • Demonstrate and apply the foundational concepts of biostatistics and epidemiology
  • Develop research questions, formulate testable hypotheses, and design clinical research studies
  • Acquire the skills needed to present clinical research effectively
  • Critically evaluate medical literature and synthesize key statistical analyses using Stata software
  • Assess the ethical principles pertinent to clinical research

Participant Types

The Foundations of Clinical Research program is designed for medical and health professionals with an advanced degree who seek to build foundational skills in clinical research. No prior research experience is required.

About the Program

The Foundations of Clinical Research program is built on the principle that comprehensive training in clinical research is essential for professional growth in the health care field. This training equips clinicians with the tools to become independent investigators and enhances their ability to advance in their careers by deepening their understanding of research evidence. Foundations of Clinical Research is tailored for medical professionals with little to no experience in interventional or observational studies.

Program Format

This program includes participation in three live virtual workshops. In addition, learners should plan to dedicate an average of 7–10 hours per week to coursework, which involves attending mandatory symposia, tutorials, Stata sessions, and seminars, as well as completing individual assignments.

Who Should Apply

The Foundations of Clinical Research program is designed for professionals holding an MD, MBBS, MB Bch, PhD, DMD, DDS, PharmD, DNP, BSN, DPT, OTD, RD, PA, or equivalent degree. The program is specifically designed for those with an interest in and aptitude for clinical research who are interested in gaining the skills and knowledge to advance their career aspirations in investigation. Applicants are not required to have prior experience in clinical research or to have authored or contributed to any previous publications.

Upon graduating from this program, our scholars are equipped with strong foundations in the fundamentals of clinical research and are prepared to take advanced courses to hone these skills.

 

Curriculum

The Foundations of Clinical Research program offers an online curriculum focused on real-time skill-based learning. The program includes 15 self-paced online lectures, over 30 hours of live sessions led by faculty, and three mandatory live-virtual weekend workshops. These intensive sessions feature live online symposia, tutorials, seminars, and STATA sessions.

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.

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

Seven 2-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)

Seven 1-hour tutorials

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

Seven 1-hour special-topic seminars

  • Tie 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 and ePoster

  • 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

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
  • How to Search PubMed
  • Overview of Evidence-Based Medicine

All participants must complete the following academic and attendance requirements in order to be granted a Certificate of Completion from Harvard Medical School.

Attendance at Workshops and Webinars

  • Learners are required to attend and actively engage in all workshops.
  • Learners may be required to attend live, interactive webinars scheduled in between workshops. If a learner cannot attend due to an occasional scheduling conflict, it may be possible to complete an alternative assignment.

Successful Completion of Assignments

  • Learners are required to complete and submit on time and receive passing grades on course-related assignments. These may include quizzes, exams and individual or team-based assignments.

Program Faculty and Teaching Team

Jamie Robertson, PhD, MPH
Senior Research Scientist, Brigham and Women’s Hospital
Assistant Professor of Emergency Medicine, Harvard Medical School

Heather J. Baer, ScD
Assistant Professor of Medicine, Harvard Medical School
Assistant Professor of Epidemiology, Harvard T.H. Chan School of Public Health
Associate Epidemiologist, Division of General Internal Medicine and Primary Care, Brigham and Women’s Hospital

Brian Healy, PhD
Assistant Professor of Neurology, Harvard Medical School
Assistant Professor in Biostatistics, Harvard T.H. Chan School of Public Health

Susan Kornetsky, MPH
Director of Clinical Research Compliance, Boston Children's Hospital

Michael Mendelson, MD, ScM
Director in Translational Medicine and Data Science, Novartis Institutes for BioMedical Research

Meaghan Muir, MLIS
Manager of Library Services, Boston Children’s Hospital

Lise E. Nigrovic, MD, MPH
Associate Professor of Pediatrics and Emergency Medicine, Harvard Medical School
Attending Physician, Division of Emergency Medicine, Boston Children’s Hospital

Djøra Soeteman, PhD
Research Scientist, Center for Health Decision Science, Harvard T.H. Chan School of Public Health

Katrin Uhlig, MD, MS
Senior Medical Director, Rare Genetic Diseases, Agios Pharmaceuticals
Adjunct Associate Professor, Tufts University School of Medicine

Paul Bain, PhD, MLIS
Research and Instruction Librarian, Harvard Medical School

Julie E. Buring, ScD
Professor of Medicine, Harvard Medical School
Professor of Epidemiology, Harvard T.H. Chan School of Public Health 
Senior Epidemiologist, Brigham and Women’s Hospital

Monik Carmen Jiménez, ScD, SM
Assistant Professor of Medicine, Brigham and Women’s Hospital
Assistant Professor, Department of Epidemiology, Harvard TH Chan School of Public Health

Susan Kornetsky, MPH
Director of Clinical Research Compliance, Boston Children’s Hospital

Martin Ingi Sigurðsson, MD, PhD
Professor of Medicine, University of Iceland

Djøra Soeteman, PhD
Research Scientist, Center for Health Decision Science, Harvard T.H. Chan School of Public Health

Eve Valera, PhD
Associate Professor of Psychiatry, Massachusetts General Hospital; Harvard Medical School

Program Fee

Program fees do not include educational materials. For more information, visit Learner Policies

  Program Fee
Application Deadline: August 6, 2025$8,900

Application Requirements

Applicants must submit a CV, a written statement, and meet specific deadlines.

To prepare your application for submission, please have the following documents available:

  • Current contact information and credentials: This information is required for the online application.
  • Curriculum vitae/résumé/list of awards or publications: You will be prompted to upload either your CV or résumé (.doc, .pdf).
  • Written statement: Please provide a 250-500 word explanation as to why you would like to be considered for this program. Please note, you may be asked for additional information to support of your submission. All program specific requirements can be found within the application.*
  • Letter of recommendation: The recommender must be a department/division head/director/chair or supervisor. The letter should be dated within 12 months of the application submission date and should address your suitability for the program and support your attendance at the workshops. Please note: The letter of recommendation may be submitted at a later date, but it is required for your application to be considered.
  • Program Fee assistance: If you are requesting program fee assistance, you will be prompted to submit a statement in support of your request. Please read the Program Fee section above for further details.
     

There is no application fee for this program.

*Your personal statement is an opportunity for the admissions committee to hear your voice. We strongly discourage the use of generative AI technologies, like ChatGPT, in your application essay. If an essay does use generative AI, then it must be acknowledged. If an essay is suspected to have used one of these tools without attribution or in its entirety, we reserve the right to deny your admission to the program or request that you submit a new essay in order to be considered.

We will acknowledge receipt of all applications and maintain all application information in strict confidence.

Students can expect to hear a decision on their application within four to six weeks from the date all application materials were submitted. Payment Plans are available for this program. Please contact the Admissions and Enrollment Services Team to learn more.

"Before joining the program, I might have just skimmed an abstract, but now I want to dive into the full article, analyze the figures, and really understand the study design."

Learner Stories and Insights

Luis Rodriguez Headshot.
Learner Story

A Physician’s Journey in Clinical Research Training

"As a doctor with an interest in clinical research, I felt it was pivotal for my career to learn how to design the study in which I’m formulating a research question and how to collect that information. This program was the perfect fit."

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