I. Background and Overview of Program
The Harvard Medical School Master of Science in Clinical Research (SMCR) program is designed for students who have completed a medical degree and aspire to become leaders in evidence-based medicine (EBM), including medical fellows or residents, junior faculty members, nurses, social workers, and other health care professionals. Current medical school students will also be considered.
The program draws upon the network, experience, and expertise of Harvard Medical School and its world-renowned hospital affiliates. As a student, you will join a community of like-minded clinicians focused on our overall mission—improving patient care and alleviating human suffering to improve health and well-being for all.
While earning your Master of Science in Clinical Research degree from Harvard Medical School, you will:
Gain a solid theoretical foundation in clinical research, including epidemiology and biostatistics
Learn about decision sciences, applied omics science, and translating innovation into clinical practice
Complete a capstone project focused on a systematic review and/or meta-analysis project
Enhance your skills and expand your knowledge to thrive in the competitive health care landscape
Mission Statement and Goals and Objectives
The primary mission of the program, in keeping with the mission of HMS, is to play a key role in the training and development of future world leaders in clinical/medical research This degree is targeted toward early career professionals as a key stepping stone toward becoming leaders in clinical science.
Program Objectives
LEADERSHIP DEVELOPMENT
Cultivate leadership skills essential for clinical research and academic scholarship
Prepare graduates to influence healthcare policy and systems
Empower students to lead multidisciplinary research initiatives
EVIDENCE-BASED MEDICINE
Deep understanding of evidence-based patient-centered approaches to improving care
Gain fluency in biostatistics, epidemiology, and applied omics science
Leverage data for decision science and guideline development
Translate research into actionable outcomes
RESEARCH IMPLEMENTATION
Apply modern research tools in clinical settings and real-world investigations
Conduct ethically sound and equitable research
Develop impactful capstone projects under expert mentorship
Upon completion of the program, graduates will be equipped for careers as clinician-scientists, academic researchers, or professionals in policy, regulatory affairs, or industry, poised to lead the future of evidence-based medicine.
Online Modality Considerations
The SMCR program considered aspects of online delivery that could support continued highquality instruction when in-person learning was limited due to visa considerations. This offered a critical opportunity to review the methods of teaching and course design for flexibility, accessibility, and effectiveness in an online environment when it needs to be adopted.
In alignment with other HMS programs, the SMCR team developed and followed a structured strategy for online readiness:
1. SMCR leadership team had an initial meeting with each individual course director and teaching assistant to discuss the transition and logistics
2. Course directors were asked to look at their curriculum and identify the broad archetype and themes of the course. The themes were used to begin discussion of instructional tools needed and the curriculum map
3. Course directors were given examples of the types of educational activities they could select from (both synchronously and asynchronously) and asked to determine which tools could best support the desired learning outcomes
4. Course directors defined a course outline and curriculum map. These contain specific information about content, hours spent on the content, and the distinction between synchronous and asynchronous delivery
5. With the specific content identified, a production plan was developed. Production needs included video recording, integration of interactive questions, and video production.
6. Course directors completed the final syllabus and worked to create the course Canvas sites. The sites were developed to support the learning objectives of the course and make the content accessible in a fully online learning modality
7. Course directors were asked to consider how the course will be evaluated given the transition to online learning.
For AY 2025–2026, the SMCR program will be offered in an online modality for the Summer semester only. The program’s commitment to academic excellence and interactive learning remains central to the experience.
Critical Elements of Curriculum Design
The foundational principles of the residential program’s original design were maintained:
Cutting-edge evidence-based curricular content for operational leaders
Opportunity to work with and learn from Harvard faculty
Opportunities for experiential learning and skills-based training
Offerings that support learners' development of a network at Harvard Medical School
Course offerings that are academically rigorous and comprise a holistic perspective of evidence-based medicine.
With consideration to HMS policies around credit hour distribution, we recommend the following range of weekly course hours based on course credits for residential courses.
The guidelines below apply to courses offered in an online modality:
Program Outline / Courses
The core SMCR program is organized as follows:
1. Introductory Foundations – Students begin with orientation and an overview of fundamental skills for academic success, leadership, teamwork, and expectations for the capstone.
2. Ethics and the Institutional Review Board – Students learn the ethical and regulatory standards for human subjects’ research, including informed consent, DEI considerations, AI applications, and emerging challenges.
3. Clinical Data Science: Design and Analytics – This course introduces epidemiological study designs, measures of association, confounding, and biostatistics fundamentals using Stata.
4. Interpreting Medical Literature, I – Students gain proficiency in searching databases and synthesizing medical evidence, which will support their systematic reviews and metaanalyses.
5. Clinical Trials – Students explore clinical trial design and operations, including adaptive trials, post-marketing surveillance, ethics, and publication standards.
6. Systematic Review and Meta-Analysis – Advanced instruction in synthesizing quantitative literature, addressing bias, conducting statistical analyses, and drawing conclusions from aggregated evidence.
7. Fundamentals of Evidence-Based Medicine I & II – These courses offer a structured exploration of EBM, including guideline development, patient preferences, critical appraisal, and evidence application.
8. Decision Science – The course provides methodological training in decision modeling, study design evaluation, guideline development, and the use of AI for clinical decision-making.
9. Leadership and Teamwork – This seminar-style course emphasizes group dynamics, feedback, leadership under pressure, and team-based assignments.
10. Artificial Intelligence in Research – Covers AI tools in research, including predictive analytics, ethics, natural language processing, and case studies in clinical implementation.
11. Applied Omics Science – Introduces genomics, proteomics, and bioinformatics applications in medical science and translational research.
12. Translating Innovation into Practice – Focuses on first-in-human trial design, biomarker validation, industry partnerships, and commercialization strategies.
13. Mixed Methods Research – Teaches integration of quantitative and qualitative research methods for comprehensive, real-world investigations.
14. Electives – With Program Director approval, students may enroll in elective courses at HMS or across Harvard to enrich their training.
The capstone experience is a required component of the Master of Science in Clinical Research program. Students will conduct an individual systematic review and meta-analysis under the supervision of a Harvard Medical School faculty advisor.
This culminating experience is designed to integrate theoretical instruction and applied skills developed throughout the curriculum. Students will identify an evidence-based problem, formulate a research question, apply appropriate methodology, and present their findings in both written and oral formats.
Successful completion of the capstone will be based on the submission of a structured proposal, regular progress checkpoints, and a final oral presentation evaluated by a Capstone Committee. This committee typically includes the student’s capstone advisor and Capstone Director
** Please note that the sequencing described above is for the full-time student. Please see the curriculum maps below for details.
II. Degree Offered
SMCR degree will be offered by HMS as a full-time, 36-credit Master of Science (SM) degree, over one academic year. Students will gain exposure to research and the different components through lectures and discussions of topics. Capstone experiences will include scholarly experiential work that is evidence-based, structured, and utilizes the quantitative methods and tools from the didactic portion of the curriculum.
III. Prerequisites for Admission
The program aims to primarily admit individuals such as medical trainees who are residents, fellows or junior faculty, medical school students with a gap or scholarly research year and other individuals who have already enrolled in or hold an MD or comparable doctoral degree from an accredited domestic or foreign institution. Eligible doctoral degrees include, but are not limited to, the following: D.D.S., D.M.D., D.O., M.B.B.S., MBChB, NP, and PA. Selected PhD and/or Master’s graduates are also encouraged to apply.
The program anticipates applications from a diverse group of students and will carefully maintain admissions statistics to ensure it is attracting and enrolling qualified students from all backgrounds, including underrepresented minorities. Applicants for whom English is not the native language, and who did not graduate from an institution where English is the preferred language, must take and pass the Test of English as a Foreign Language (TOEFL) or International English Language Testing System (IELTS) or the Duolingo examinations. A minimum score of 103 on the TOEFL, 8 on the IELTS or 130 on the Duolingo is required for admission to the SMCR program.
The admissions process will evaluate academic and professional achievement, appropriate interest in pursuing a clinical research career, plans for future directions after completion of the program, and commitment to devote sufficient time to master the program content. The admissions process will be coordinated within the overall umbrella structure of Master of Medical Sciences in Clinical Investigation (MMSCI), which will help to ensure students are guided towards the optimal educational offering for their individual needs and goals. There is no mechanism to transfer between degree programs. Requests to participate in a different degree would require withdrawal from one program and a new competitive application to the other.
Applicants will be asked to provide the following application materials:
Online application
Curriculum Vitae
Letter of interest in the SMCR program
Writing Sample
Undergraduate and graduate transcripts
Two letters of recommendation – preferably from a current or recent mentor, advisor or supervisor
IV. Academic Residence Requirements
In order to graduate with the degree of Master of Science in Clinical Research, students must fulfill all of the program’s academic and attendance requirements, including completion of the 36-credit curriculum and a successful oral capstone presentation. A degree will not be granted to any student who is not in good standing or against whom a disciplinary charge is pending. In addition, a student’s term bill must be paid in full before they will be awarded the degree.
A detailed look at the HMS academic and financial policies can be found in the Student Handbook.
IV. Course of Study
Curriculum by term
The program begins in July 2025 and ends in May of 2026 for full-time students.
Full Time status
Full-time students in the SMCR program will complete approximately 36 credits distributed across the Summer, Fall, J-term, and Spring terms.
Emphasis for the 2025-2026 academic year:
Continued refinement of course content based on student feedback and field advancements.
Enhanced integration of Diversity, Equity, and Inclusion (DEI) principles in course objectives and assessments.
Capstone updates to further showcase student scholarship and applied research skills.
Integration of AI technology and emphasis on latest research endeavors
Full-time curriculum map
Course Sequencing
Summer Term (July)
CI 742: Fundamental Skills for Academic Success (1)
CI 700: Ethics and the IRB (1)
CI 701: Design and Analytics (3)
CRES 701: Organized Basic Evidence Based Medicine (2)
Fall Term (Sept-Dec)
CRES 709: Interpreting Medical Literature Part I (2)
CI 702A: Clinical Trials Part I (1.5)
CRES 705: Systematic Review and Meta-analysis (4)
CRES 703: Developing Therapies for Patients (2)
CRES 719: Capstone I (3)
January Term
CI 740: Leadership and Teamwork (2)
CRES 706: Mixed Methods Research (2)
Spring Term (Feb-May)
ELECTIVE: AI in Research & Education (2)
CRES 710: Interpreting Medical Literature Part II (2)
Clxx: Evidence-Based Guidelines for Development (2)
CRES 712: Survey of Modern Omics: Theory and Applications (3)
CI 766: Translating Innovation into Practice (2)
CRES 720: Capstone II (3)
VI. Course Descriptions
CI 742: Fundamental Skills for Academic Success
(Course Director: Martina McGrath, MBBCh)
This course is designed to give students an overview of some of the key skills that will support their experience as graduate students. We will review how we can learn more effectively and why having a growth mindset is essential in graduate school and professional life. Students will analyze and discuss key challenges in professionalism (communication, respect, biases, academic honesty, etc.). Furthermore, we will focus on building and strengthening essential time management, goal setting, and academic strategies.
CI 700: Ethics and the Institutional Review Board
(Course Directors: Susan Kornetsky, MPH and Benjamin Silverman)
This course will examine the regulatory and ethical oversight of the history and evolution of ethical research codes and regulations. The role and responsibility of principal investigators will be discussed. The course will include the history of research ethics and touch upon the ethics of animal research, which is often the precursor to trials in human beings. Information about preparing research protocol applications and informed consent documents for clinical research will be provided. The course also will review some current and common challenges in the ethical conduct of research, including consideration of diversity, equity, and inclusion; recruitment practices; vulnerable populations; and topics such as artificial intelligence (AI) and machine learning, genomics, and the use of social media in research. The importance of considering the perspectives of subjects and patients in clinical research will also be explored. The course will include didactic and group work emphasizing critical thinking and practical application of ethical considerations while developing and implementing patient-oriented research.
CI 701: Design and Analytics
(Course Directors: Brian Claggett, PhD & Elizabeth Mostofsky, S.D)
Clinical research requires the generation and analysis of data for three tasks: description, prediction, and causal inference. The course will introduce measures of frequency and association, study designs, and basic methods to understand and address confounding. The biostatistics component will introduce data types, data summaries, hypothesis testing, the essentials of statistical inference, and statistical methods for calculating summary estimates, measures of variability, confidence intervals, sample size calculations, and concepts for modeling. All methods are taught along with Stata software to implement them.
CRES 701: Fundamentals of Evidence-Based Medicine
(Course Directors: Nuha ElSayed, M.D. & Raveendhara Bannuru, MD, PhD)
This course offers a comprehensive exploration of the fundamental principles and practices of evidence-based medicine (EBM). Designed for healthcare professionals, researchers, and students, this course provides a structured framework for understanding how to integrate the best available evidence into clinical decision-making. Participants will gain a solid foundation in critical appraisal skills, enabling them to assess the quality and relevance of medical literature, including clinical studies, systematic reviews, and meta-analyses. Through a combination of lectures, case studies, and interactive discussions, students will learn to formulate clinical questions, search for evidence effectively, and apply the findings to real-world patient care scenarios. Additionally, the course will emphasize the importance of considering patient values and preferences in decision-making, promoting a patient-centered approach to healthcare. By the end of the course, participants will be equipped with the knowledge and skills necessary to navigate the ever-evolving landscape of medical information and make evidence-based decisions that improve patient outcomes.
CI 702A: Clinical Trials Part I
(Course Director: David Wypjj, PhD)
The goals of this course are to develop a fundamental understanding of how clinical trials are conceived, funded, developed (including protocol development and, in the case of industry trials, the industry approval process), conducted, and closed out. Key topics will include different trial designs (adaptive, point-of-care, pragmatic, etc.), trials in different settings (emergency, pediatrics, cancer, biomarker, device, etc.), statistical monitoring of trials, safety issues, secondary analysis of clinical trial data, committee organization and management, advanced ethics, post-marketing surveillance studies, and writing up trials for publication. Practical examples mixed with theory will be emphasized.
CI 766: Translating Innovation into Practice
(Course Director: Sowmya Chary, M.B, B.S)
This course is designed to introduce translating research innovations into clinical practice. It will examine the design of first-in-human studies (including integration of translational medicine approaches, biomarker discovery, and validation), the regulatory process to bring innovation to the clinic, and academic-industry partnerships. Discussion topics, including how to secure funding through industry networks and how to approach commercializing a discovery, will be illustrated through case examples from guest lecturers.
CRES 709: Interpreting Medical Literature Part I
(Course Director: Sagar Nigwekar, MD & Wyn Williams, MD)
This course will provide students with the necessary tools to critically analyze and comprehend articles published in medical journals. The article types will include but not limited to original articles, review features, editorials, and perspectives. For original research articles focus will be on critically appraising the study design, methodology, results, and conclusions to determine their validity and applicability to
clinical practice and future research. The overarching goal of the course will be to master the skill of medical literature reading and interpretation to inform scientific inquiry and clinical care. Course components will include live sessions, interactive modules, readings, and online discussion forums. By the end of the course, learners will have skills to critically analyze and understand research articles from the medical field, allowing them to effectively evaluate the validity and applicability of findings to inform clinical decision-making, by teaching them how to assess study design, statistical methods, and potential biases within published medical literature
CRES 710 Interpreting Medical Literature Part II
(Course Director: Sagar Nigwekar, MD and Wyn Williams, MD)
Interpreting Medical Literature Part 2 builds on the foundational skills developed in Part 1 by advancing students' abilities to critically analyze more complex and specialized medical literature. Students will deepen their knowledge through the appraisal of efficacy and safety data, diagnostic test evaluations, qualitative and mixed methods research, genomics studies, and implementation science literature. This course emphasizes application through skills-based assessments that include case studies, guideline evaluations, and integrative analyses. By the end of the course, students will not only assess individual studies but also synthesize broader evidence bases to inform clinical decision-making and research initiatives.
CRES 705: Systematic Review and Meta-analysis
(Course Director: Christina Ellervik, SMSc, DPD, MD)
The systematic review and meta-analysis course will be an advanced research methodology course designed to equip students with the skills and knowledge necessary to conduct comprehensive and rigorous syntheses of existing research literature. This course delves into the principles and techniques of systematically gathering, critically appraising, and synthesizing primary research studies, with a particular focus on quantitative approaches like meta-analysis. Students will learn to formulate clear research questions, search for relevant studies across various databases, and assess the quality and bias of included studies using established tools and guidelines. The course also covers statistical methods for combining data from multiple studies, exploring heterogeneity, and drawing meaningful conclusions. Additionally, ethical considerations, publication bias, and the interpretation of results will be discussed. By the end of the course, students will be well-prepared to contribute to evidence-based decision-making in their respective fields and to conduct rigorous systematic reviews and meta-analyses of their own.
CRES 703: Developing Therapies for Patients
(Course Director: Ajay K Singh, MBBS, FRCP, MBA and Yousef Farag)
The “Developing Treatments for Patients” course delivers a deep, clinically oriented dive into the science, strategy, and practice of clinical development, focusing on bringing new pharmaceutical treatments and devices from concept to market. By examining core scientific principles and research methodologies, students will learn how to conduct thorough benefit-risk assessments, craft comprehensive clinical development plans (CDPs), and formulate precise target product profiles (TPPs) that guide the strategic direction of a drug’s lifecycle. The curriculum also delves into the nuanced regulatory environments, primarily of the United States but also other parts of the world, empowering participants to navigate complex approval pathways with confidence. Beyond regulatory considerations, the program covers critical aspects of commercialization, including patent protections, pricing strategies, market access, and lifecycle management; equipping students with the skills to develop a medicine that will optimize its market potential and sustain its value. Throughout the course, learners will develop the analytical mindset and practical expertise needed to successfully plan and execute the development of innovative treatments that address unmet medical needs and ultimately improve patient outcomes. CRES 706: Mixed Methods
(Course Director: Lourdes Perez Chada, MD MMSc and Rebekka Lee, ScD)
This intensive two-week course provides a comprehensive introduction to mixed methods research, combining theoretical foundations with practical application. Over the course of seven sessions (three hours each), students will learn to integrate qualitative and quantitative approaches to address complex research and practice problems. Students will develop a clear understanding of mixed methods research and its three core designs: convergent parallel, explanatory sequential, and exploratory sequential. The curriculum emphasizes the importance of mixed methods research in producing rich, actionable insights and equips students with tools to define, design, and apply this methodology in diverse fields.
Course components will include daily readings and live sessions with a combination of didactic lectures and in class small group/pair share activities along with guest lectures focused on applications of mixed methods across a variety of topics. The course culminates in a final project, where participants will create a diagram of a mixed methods design tailored to a specific research or practice scenario. By the end of the course, students will be prepared to apply mixed methods research confidently and effectively in their work.
Clxx: Evidence-Based Guidelines for Development
(Course Directors: Nuha ElSayed, M.D. & Raveendhara Bannuru, MD, PhD)
This comprehensive course on guidelines in evidence-based medicine offers a thorough exploration of the principles and practices that underpin the field of evidence-based medicine (EBM). Designed for health care professionals, researchers, and students, this course equips participants with the essential skills and knowledge needed to critically appraise and apply clinical guidelines effectively. Throughout the course, participants will delve into the foundations of EBM, gaining a deep understanding of how evidence is generated, assessed, and synthesized. They will learn to navigate the hierarchy of evidence from randomized controlled trials to observational studies, understand the importance of systematic reviews, and meta-analyses in evidence synthesis. Participants will also explore the nuances of guideline development, including the role of expert panels, the GRADE system, and the integration of patient preferences and values. Practical sessions will involve hands-on experience in appraising clinical guidelines and identifying potential biases or conflicts of interest. Furthermore, the course will address the application of EBM principles in clinical decision-making, emphasizing the importance of shared decision-making and patient-centered care. Participants will gain proficiency in interpreting and communicating guideline recommendations to patients, enhancing their ability to provide evidence-based, high-quality health care. By the end of this course, participants will be well-equipped to critically assess clinical guidelines, make informed clinical decisions, and contribute to the advancement of evidencebased health care practices in their respective fields. Whether you are a health care practitioner, researcher, or student, this course will empower you to navigate the dynamic landscape of EBM and leverage it for the benefit of patient care and medical research.
CRES 712: Survey of Modern Omics: Theory and Methods
(Course Director: Su H. Chu, Ph.D., M.S.)
This intensive two-week course provides a comprehensive introduction to mixed methods research, combining theoretical foundations with practical application. Over the course of seven sessions (three hours each), students will learn to integrate qualitative and quantitative approaches to address complex research and practice problems. Students will develop a clear understanding of mixed methods research and its three core designs: convergent parallel, explanatory sequential, and exploratory sequential. The curriculum emphasizes the importance of mixed methods research in producing rich, actionable insights and equips students with tools to define, design, and apply this methodology in diverse fields. Course components will include daily readings and live sessions with a combination of didactic lectures and in class small group/pair share activities along with guest lectures focused on applications of mixed methods across a variety of topics. The course culminates in a final project, where participants will create
a diagram of a mixed methods design tailored to a specific research or practice scenario. By the end of the course, students will be prepared to apply mixed methods research confidently and effectively in their work.
CRES 719: Capstone I
(Gearoid McMahon, MB, BCh)
Students in the Master of Clinical Research program will complete an experiential capstone experience as a required component of their degree. This project will demonstrate the progressive achievement of key competencies necessary for a master's student. Students will be asked to apply the tools, strategies, and methods from their didactic courses to develop a solution to an evidence-based problem seen in healthcare delivery.
Each student will work on an individual systematic review or meta-analysis under the supervision of an HMS advisor. This experience provides an opportunity to engage in rigorous research, critically analyze existing literature, and synthesize findings to contribute to evidence-based healthcare improvements. Successful completion of the capstone will be based on an assessment of a written proposal and an oral presentation. These components will ensure students effectively communicate their research findings and demonstrate their ability to apply learned methodologies in a structured and scholarly manner.
VII. Expectations for students by term or year
Students will be formally evaluated in each course, through participation, online quizzes and homework, team projects and written work. Attendance is required for all course meetings. Students must pass all courses to receive credits.
Students will complete a mentored capstone experience. A written report that includes required elements of the capstone must be submitted to the program leadership.
Students will meet with the Program Director at least twice during the academic year.
Students will meet with their project mentor as established at the start of the project, at least monthly, and more frequently as the project dictates.
VIII. Assessment
Students receive a final grade for each didactic course they take. This will be a satisfactory/unsatisfactory rating. In addition, students are evaluated throughout each course through regular homework assignments, online quizzes, class participation, and team-based projects that are presented orally and in written form. Students must meet monthly with their capstone advisor and submit progress reports mid-year. This report will match elements of the capstone requirements. The Capstone advisory group will include the primary site mentor and the Capstone Director.
IX. Length of Time to Degree
Students are expected to complete the SMCR degree program in one academic year as full-time enrollees.
Requirements for Graduation
Completion of the 36-credit curriculum, including a Capstone presentation with a written report, is required. Students are expected to meet all academic, professional, and financial obligations required by the HMS Master’s programs and outlined in the HMS Master’s student handbook. A degree will not be granted to a student who is not in good standing or against whom a disciplinary charge is pending.
X. Capstone Monitoring
The capstone project remains a key element of the SMCR program, even in a remote learning environment. In the online program, the capstone is supported by a tripartite collaboration between the student, their home institution mentor, and an HMS-based coach. The combination of the local mentor, the HMS coach, and program director formed the students’ capstone advisory group. This group is tasked with determining progressive achievement of the key competences required for an SMCR student. The capstone is entered and tracked via milestones in Canvas, which allows for bidirectional feedback and the opportunity to document changes. Students submit worksheets as well as 2 drafts and 1 final Capstone paper. Students receive feedback on all drafts and are expected to incorporate feedback into the final capstone paper. The paper is assessed by the capstone advisory group and an outside reviewer, each of whom assign scores and provide written feedback.
The student, and his/her local and HMS coaches me et via videoconferencing if needed during the academic year in in alignment with the project milestones.
XI. Advising
Each student will benefit from ongoing advice from their primary mentor, in addition to the input from the Capstone advisory group. Students will also meet individually with the Program Director twice per academic year for formal career guidance and support. Program leadership will be available for any concerns throughout the year.
XII. Financial Aid
Program applicants are encouraged to apply for external grants and fellowships whenever possible. The Office of Financial Aid has the most up to date information on funding sources and students are encouraged to work with this office to determine their eligibility for scholarships and financial aid.