Foundations of Clinical Research

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)
• Hands-on guidance for implementing the related analysis with statistical programming in Stata

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

• 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

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

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

Workshop Attendance Requirements

Attendance at the program’s workshops is a requirement. If a student cannot attend a workshop, a petition must be submitted to the Course Education Committee for review and approval.

Assignments, Exams, and Quizzes

Students are required to complete and pass all individual assignments, exams, and quizzes.

Symposium, Tutorial, and Seminar Attendance

The program requires students to attend scheduled live online symposia, tutorials, and seminars. If a student cannot attend a live online symposium, tutorial, or seminar due to occasional scheduling conflicts, it is possible to review the recording of the webinar. Students are expected to attend 75 percent or more of scheduled live online sessions.