Foundations of Clinical Research

This Harvard Medical School six-month, application-based certificate program provides the essential skill sets and fundamental knowledge required to begin or expand your clinical research career.

Women at computer assessing research

Associated Schools

Harvard Medical School

Harvard Medical School

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

Assignments

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

Instructors

Jamie Robertson

Jamie Robertson

Djøra Soeteman

Djøra Soeteman

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Clinical Research: An Introduction

Foundational course covering the core components of the clinical research enterprise.

About this Course

This course provides the basic concepts of what clinical research is, how it is carried out and by whom, and its underlying ethical and regulatory framework. It discusses the key principles of Good Clinical Practice such as data management and the protection of human subjects. It further explores specific issues in clinical research, including protocol design, critical regulations and oversight bodies, common types of clinical trials, regulatory compliance, and clinical research billing.

Note: The course provides an overview of the clinical research enterprise and its parts. It is meant to supplement (not replace) Human Subjects Research (HSR)  and  Good Clinical Practice (GCP)  courses.

Course Preview:

Language Availability: English

Suggested Audiences: Clinical Billing Professionals, Clinical Data Managers, Clinical Research Coordinators (CRCs), Compliance Officers, Contract Research Organizations (CROs), Faculty and Post-Docs, IRB Administrators, IRB Members, Legal and Risk Management Staff, Research Administrators, Researchers, Sponsors, Students

Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations Independent Learner Price: $99 per person

Course Content

  • Understanding U.S. Clinical Research

This module explores the nature and purpose of clinical research, how it differs from clinical care, and the institutional and organizational conditions that shape the research enterprise. The module provides information on the pharmaceutical and medical device industries and regulatory oversight. It outlines the institutional roadblocks to an efficient research enterprise and also describes the role that clinical research plays for public health in general.

Recommended Use: Required ID (Language): 20463 (English) Author(s): Quincy Byrdsong, EdD, CIP, CCRP - Lipscomb University

  • Common Types of Clinical Trials

This module walks the learner through different clinical trial types and study phases related to drug and medical device development. Learners explore common types of study designs, their various classifications, and how they address different research questions. The module also considers principles of quality by design and subject selection as they relate to the study design.

Recommended Use: Required ID (Language): 20464 (English) Author(s): Dawn N.L. Pittinger, MBA, CHRC, CRCP - Moffitt Cancer Center

  • Critical Regulations and Oversight Bodies

This module summarizes ethical principles governing clinical research. It provides an overview of the FDA’s structure, jurisdiction, and regulatory functions and introduces the reader to IRBs. It discusses clinical investigations that generate the data to support FDA marketing applications and FDA enforcement of its requirements. Learners explore how investigations provide evidence that a new product is both safe and effective. The module touches on U.S. funding agencies’ requirements for clinical research and concludes with an overview of some major international GCP standards.

Recommended Use: Required ID (Language): 20465 (English) Author(s): Kris West, JD, MS - Council on Governmental Relations (COGR)

  • Overview of the Clinical Research Enterprise

This module surveys the clinical research enterprise by focusing on the roles and responsibilities of different parties involved in clinical research administration, oversight, and operations. Learners examine the involvement of auxiliary offices as well as the use of different organizational structures to administer clinical research. The module concludes by contrasting sponsored research with non-sponsored research to identify common personnel and staffing practices.

Recommended Use: Required ID (Language): 20466 (English) Author(s): Quincy Byrdsong, EdD, CIP, CCRP - Lipscomb University

  • Overview of a Protocol and Designing a Clinical Trial

This module describes protocol development and use in clinical research. It details how the protocol guides investigators, sponsors, monitors, and research stakeholders on how to conduct and oversee the trial. Learners will gain an appreciation of how a protocol helps regulators and ethics boards to understand study procedures and identify any risks for potential subjects. The module concludes with a discussion of study and investigator feasibility assessments.

Recommended Use: Required ID (Language): 20467 (English) Author(s): Melissa Byrn, MS, MBE - Polsky Center for Entrepreneurship and Innovation and University of Chicago

  • Data Management in Clinical Research

This module introduces the sources of clinical data, how and where investigators collect data, and best practices for data management. It details how data is reported and the means of ensuring data quality, uniformity, and integrity across subject histories. Learners will explore methods for capturing and collecting data from paper sources, electronic health records, and other digital origins. The module concludes by identifying recent trends in best practices for data management.

Recommended Use: Supplemental ID (Language): 20468 (English) Author(s): Melissa Byrn, MS, MBE - Polsky Center for Entrepreneurship Innovation and University of Chicago

  • Ensuring Compliance

This module defines compliance and outlines how it merges with ethics to encompass research integrity at an institution, site, or company. The module details how compliance with GCP serves core functions within clinical research. It reviews key areas of research compliance programs including policies and procedures, training and education, and risk assessments. Learners explore the application and limitations of privacy and confidentiality protections under HIPAA for research. The module concludes by outlining types of scientific misconduct and the means to prevent them.

Recommended Use: Supplemental ID (Language): 20469 (English) Author(s): Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP - Kelly Willenberg & Associates

  • Overview of Clinical Research Billing

This module highlights clinical trial budgeting and billing processes from a site perspective for industry sponsored clinical trials. It defines the components of a clinical research budget, discusses potential hidden costs for a research site, and identifies insurance billing requirements. The module concludes by detailing how good budgeting is important, how it relates to coverage analysis, and what guidelines and rules apply to research billing.

Recommended Use: Supplemental ID (Language): 20470 (English) Author(s): Marie Jackson, PhD, MBA - Methodist le Bonheur Healthcare

" role="button"> Computerized Systems in Clinical Research

This module discusses types of clinical research technologies used within clinical trial operations. It identifies how electronic systems enhance clinical trial compliance, improve site efficiencies, promote transparency in clinical trial conduct, and enhance safety and oversight of human research subjects. The module also explains the implications of the regulations at 21 CFR Part 11 on the implementation and use of computerized systems in clinical trials.

Recommended Use: Supplemental ID (Language): 20471 (English) Author(s): Candida Barlow, PhD, MSN, CRN-BC, RN - Oklahoma State University

Who should take the Clinical Research: An Introduction course?

The course is designed for individuals new to clinical research or looking to enter into a related field, including undergraduate and graduate students, university faculty and postdocs, research compliance officers, new clinical investigators, clinical research coordinators, research administrators, institutional officials, clinical data managers, and clinical billing professionals.

How does the Clinical Research: An Introduction course complement other CITI Program courses?

Clinical Research: An Introduction serves as a helpful precursor to taking CITI Program courses in the Good Clinical Practice (GCP) series, Human Subjects Research (HSR) series, and Responsible Conduct of Research (RCR) series. By providing a description of the conduct and context of clinical trials, this course provides leaners with the opportunity to better understand the regulatory and ethical dimensions of clinical research.

This course is not designed to replace other CITI Program courses (such as GCP , HSR , or RCR ).

Why should someone take the Clinical Research: An Introduction course?

Learners who wish to gain a foundational understanding of the clinical research enterprise should take this course to prepare for a career in clinical research or to gain necessary knowledge for those roles interfacing with clinical researchers.

This course can be used in onboarding for those new to research, or for those taking on new roles that involve interaction with research offices or include research responsibilities.

How long will the course take a learner to complete?

This course consists of eight modules.  Each module contains detailed content and a quiz, as well as images, supplemental materials, and case studies.

Modules vary in length, and learners may require different amounts of time to complete them based on their familiarity and knowledge of the topic. As a rule of thumb, modules can take about 30 to 45 minutes to complete, which means it could take around four to six hours to complete all eight modules.

Is this course eligible for continuing medical education credits?

This course does not currently have CE/CME credits available.

What are the required and supplemental modules for learner groups?

This course is designed to be completed sequentially through its first five modules (we recommend they are set as “required”). The three following additional modules should be set for “supplemental.” These supplemental modules are recommended for individuals interested in those specific topics. The supplemental modules provide rich information relevant to clinical research but not essential for the learner to gain a foundational knowledge of clinical research.

Supplemental

What are the advantages of the Clinical Research: An Introduction course?

This course provides peer-reviewed training written by clinical research experts. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for clinical research training.

Related Content

GCP consists of basic and refresher courses that provide essential good clinical practice training for research teams involved in clinical trials.

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Provides clinical research professionals with basic and advanced training tailored to the CRC’s critical role in the conduct of clinical trials.

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This role-based course covers supervision, delegation, management, reports, and communication for investigators.

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This course focuses on developing the knowledge and skills necessary to maintain compliance and best practices associated with clinical research billing.

Clinical Research: An Introduction

An in-depth review of the development and execution of protocols.

roadmap with stops along the way

This course provides an overview of research administration.

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Stanford Online

Epidemiology and clinical research graduate certificate.

Stanford School of Medicine , Stanford Center for Health Education

Get Started

“From providers and patients developing treatment plans to governments creating policies affecting the lives of millions, we depend on evidence from scientific research that is rigorous, credible, and valid to make informed decisions.”—Meta-research Innovation Center at Stanford

Collecting, analyzing, and interpreting data is a cornerstone of modern medicine, helping us to improve the lives of people around the planet by diagnosing, treating, and preventing human diseases. This enterprise requires multidimensional thinkers who combine statistical know-how and a strong understanding of research methods and medicine.

The Epidemiology and Clinical Research Graduate Certificate provides students the knowledge and skills essential to patient-oriented clinical research. You will learn how to critically evaluate a published paper, conduct peer review of a research manuscript or grant, develop a study protocol for an observational or clinical trial, develop an analytic approach appropriate for the proposed study, and conduct data analysis and interpret its results.

Topics Include:

  • Design of epidemiologic studies
  • Statistical analysis medical applications
  • The basics of probability and statistical inference
  • Beginning and intermediate R and SAS programming
  • Theory of clinical research
  • Phases of clinical trials

The Epidemiology and Clinical Research Graduate Certificate is offered by the Epidemiology and Population Health Department at Stanford School of Medicine—a leader in cancer epidemiology, infectious disease epidemiology, neuroepidemiology, cardiovascular disease epidemiology, musculoskeletal disease epidemiology, and epidemiologic methods.

Required (complete 3)

Introduction to Epidemiologic and Clinical Research Methods

  • Online, instructor-led

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Elective (complete 1)

Course image for Intermediate Epidemiologic and Clinical Research Methods

How Much It Will Cost

How long it will take.

  • Complete four graduate courses within 3 academic years. Three from the required course list and one elective.
  • Your time commitment will vary for each course. You should expect an average of 15-20 hours per week for the lecture and homework assignments.
  • On average students complete the program in 9 months, but students may opt for a longer period of time

What You Need to Get Started

Before enrolling in your first graduate course, you must complete an online application .

Don’t wait! While you can only enroll in courses during open enrollment periods, you can complete your online application at any time.

Once you have enrolled in a course, your application will be sent to the department for approval. You will receive an email notifying you of the department's decision after the enrollment period closes. You can also check your application status in your my stanford connection account at any time.

Learn more about the graduate application process .

What You'll Earn

Graduate Certificate Sample

You’ll earn a Stanford Graduate Certificate in Epidemiology and Clinical Research when you successfully earn a grade of B (3.0) or better in each course in the program.

With each successful completion of a course in this program, you’ll receive a Stanford University transcript and academic credit, which may be applied to a relevant graduate degree program that accepts these credits. If admitted, you may apply up to 18 units to an applicable Stanford University master’s degree program (pending approval from the academic department).

This Stanford Graduate Certificate is accredited by the Western Association of Schools and Colleges Senior College and University Commission (WSCUC).

Graduate Certificates are delivered as a digital credential document, verified on the blockchain. You’ll be able to share your accomplishments, verify your credential, and communicate the scope of your acquired expertise.

What You Need to Apply

  • Students are encouraged to take these classes in sequence, as each class builds on the previous classes; however, we will consider students who wish to take only one class – in such cases, students may be required to demonstrate knowledge of prerequisite material.
  • A conferred Bachelor’s degree with an undergraduate GPA of 3.0 or better.

Teaching Team

Stephen Luby

Stephen Luby

Professor, Infectious Diseases

  • School of Medicine

Dr. Luby studied philosophy and earned a Bachelor of Arts summa cum laude from Creighton University. He earned his medical degree from the University of Texas Southwestern Medical School at Dallas and completed his residency in internal medicine at the University of Rochester-Strong Memorial Hospital. He studied epidemiology and preventive medicine at the Centers for Disease Control and Prevention.

Dr. Luby's previous positions include directing the Centre for Communicable Diseases at the International Centre for Diarrhoeal Diseases Research, Bangladesh in Dhaka, Bangladesh from 2004 - 2012, conducting research and teaching epidemiology at the Aga Khan University in Karachi, Pakistan from 1993 - 1998, and working as an epidemiologist in the Foodborne and Diarrheal Diseases Branch of the U.S. Centers for Disease Control and Prevention.

Rita Popat

Clinical Associate Professor

Epidemiology and Population Health

Rita's research interest focuses on the epidemiology of Parkinson's disease and amyotrophic lateral sclerosis, specifically evaluating the genetic and environmental contributions to these neurodegenerative disorders. She is also interested in studying the relation of cognition, estradiol exposure (endogenous and exogenous), and genetic factors.

Kristin Sainani

Kristin Sainani

Kristin Sainani (née Cobb) is an associate professor at Stanford University and also a health and science writer. After receiving an MS in statistics and a PhD in epidemiology from Stanford University, she studied science writing at the University of California, Santa Cruz. She has taught statistics and writing at Stanford for more than a decade and has received several Excellence in Teaching Awards from the graduate program in epidemiology. Dr. Sainani writes about science and health for a range of audiences. She authored the health column Body News for Allure magazine for a decade. She is also the statistical editor for the journal Physical Medicine & Rehabilitation; and she authors a statistics column, Statistically Speaking, for this journal.

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CCRPS

Clinical Research Certification

Clinical research training.

Our clinical research training program s have supported over 22,000 members in the past 7 years. CCRPS clinical research courses   are used by students at 1,200+ organizations, 6 governmental agenies, and 308 universities. Graduates of our clinical research certification have worked at over 1,600 different organizations including all major known CROs and 23% of our graduates have obtained managerial or higher level roles (2024 CCRPS LinkedIn Graduate Survey).  We offer personalized  clinical research career coaching  after clinical research course completion.  See April 2024 Graduate Case Studies .  

We have major clinical research training accreditations including Transcelerate Biopharma, ACCRE, and offer CME for physicians, nurses, and pharmacists through AMA, ANCC, and ACPE.  We are a candidate to become a federally-qualified institution with MSA-CESS. 

We are dedicated to our evidence-based and practice-based education philosophy to help you  learn clinical research  through simply great content unlike what you may have seen before. Clinical research training is self-paced, online, on-demand so you can start today and finish on the go with our mobile app. Speak to our 24/7 chat team or book with a course advisor to see which path is best for you. 

Speak to Course and Career Adviser Liz 









CCRPS Course Catalog

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clinical research courses near me

Advanced Principal Investigator Physician Certification (APIPC)

Industry-Recognized PI Training I Modifiable courses based on prior experience I On-Demand I 17.5 CME I 100+ Modules (only review those you don't know) I GCP Complaint I Instant Enrollment I 1D-2 Wks for Certification

clinical research courses near me

Advanced Physician Medical Monitor Certification (APMMC)

Advanced Physician Medical Monitor Certification (APMMC) Triple-Accredited I Written by Physicians I 17.5 CME AMA/ACCME I 250 Hours I 100+ Modules I GCP Complaint I Instant Enrollment I 2+Wk Certification I

clinical research courses near me

CCRPS Clinical Research Community

CCRPS Reviews

CCRPS Graduate Case Studies April 2024

We’re thrilled to share more graduate case studies from graduates of our program. We value full transparency so full case study transcripts and videos will be available at your request. Please email our case study interviewer Courtney Fulkerson, a clinical research project manager herself, at [email protected] if you have any questions about this process.   

Need help deciding on a course or motivating yourself to finish your current course? We want to help you succeed. Speak with our course advisor in clinical research field herself, Liz. Schedule course and career advising session today (email [email protected] your resume before meeting). 

1. From IMG to Clinical Research Coordinator at Columbia University: “ This course not only met but exceeded my expectations with its thorough curriculum and insightful modules.” -Lisa-Pierre ( view full case study )

2. From IMG to Clinical Research Coordinator “The hands-on activities integrated throughout the course really helped solidify my understanding of complex concepts.” - Unber Mahmood ( case study summary )

3. Promoted to Senior Startup Specialist in Clinical Trials : “I appreciate how the course was structured—very interactive and engaging from start to finish.” - Justin Scott Brathwaite  ( transcript summary )

 4.  From Physical Therapist to Clinical Researcher:  “The in-depth content and expert instructors provided me with invaluable insights into the field.”  - Celia Moon ( case study summary )

5.  ICH GCP Usability Confidence :   “Thanks to this course, I feel more competent and confident in my role.” - Stephanie ( case study summary )

6.  Enjoyed Clinical Research Training through Examples  “The real-world examples used throughout the course were incredibly useful for applying theory to practice.”  -Marta Marszalek ( view full case study )

7.  From Clinical Research Receptionist to Certified Study Coordinator with CCRPS:   “I highly recommend this course for its comprehensive approach and practical applications.”  - Katie Decker ( view full case study ) 

8.  From International CRC to U.S. Lead CRC and CRA:   “The flexible online format allowed me to balance my studies with my professional commitments seamlessly.” - Aishwarya Sukumar  ( view full case study )

9.  Learning to Lead Safety Associate: "The course materials were clear, well-organized, and directly applicable to my work.” - Renata Noronha ( view full case study )

10.  From IMG to securing roles as a CRC, CRA, and now a project manager: “Joining this course was a pivotal step in my career advancement.”  - Dr. Vrushali Borawak ( view full case study )

11.  From Physician to Confident Drug Safety Specialist:  “The course provided a robust foundation in the field, which was critical for my professional development.” - Rabiea Bilal ( view full case study )

12.  From plant biologist to clinical recruitment administrative coordinator : “This program is a gateway to extensive knowledge and skills in a supportive learning environment.”  -Olajumoke Owati  ( view full case study )

13.  From International PV Roles To North American Market Success: “The detailed modules prepared me excellently for real-world applications.” - John Vinil ( view full case study )

14.  From Educational Research to Clinical Trials Project Manager:   “I was able to immediately apply what I learned in the course to my job. ” - Rose Hyson ( view full case study )

15.  From Masters in Health Safety to Clinical Researcher:   " I will say quality of delivery, quality of the materials.   - Ossai Opene  ( view full case study )

16.  ICH GCP made her more confident in research:  "this course just overall did a really good job going in depth, which I feel like wasn't just, it wasn't just covered just for the sake of covering content" -  Aastha Shah  (view full transcript)

17.     From Grant Program Manager to Leading Clinical Trials at UCSF :  "it really did a great job of the full scope of clinical research from start to finish.  Since completing the course, I've received a promotion at work. "  -Hannah Fischer  (view HF clinical research training case study)

18.   From Clinical Research Intern to Regulatory Affairs Associate at UPenn: "I would say since then. I've completed this course. It's helped me get my job in regulatory affairs at a clinical research site." - Scott Boyle   (view SB full case study)

19.   From Clinical Research Monitor to Chief Medical Officer for CRO: " And CCRPS has a a complete, you have a really, really good approach to that. Because that is what we offer to our sponsors, quality and safety, because we are all physicians."   - Maria Lopez (full case study report pending)

18.   From International Pharmacist to Pharmacovigilance:   The pharmacist detailed challenges becoming a pharmacist in the US and choosing CCRPS for flexibility. Certification benefits were gaining clarity on research topics and standing out for clinical research roles.   - Ijeoma Osunwa   (full case study report pending)

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clinical research courses near me

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Clinical Research Courses and Certifications

Learn Clinical Research, earn certificates with paid and free online courses from Harvard, Stanford, University of Michigan and other top universities around the world. Read reviews to decide if a class is right for you.

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Understanding Clinical Research: Behind the Statistics

If you’ve ever skipped over`the results section of a medical paper because terms like “confidence interval” or “p-value” go over your head, then you’re in the right place.

  • 1 day 3 hours 11 minutes
  • Free Online Course (Audit)

Improving Healthcare Through Clinical Research

On this free online course, find out how medical treatments are discovered, tested and evaluated to improve healthcare for all.

  • FutureLearn
  • 4 weeks, 4 hours a week

What is Health Research?

Explore the world of health research and the role volunteers play in transforming treatments and improving health care.

  • 3 weeks, 3 hours a week

Current Regulatory Requirements for Conducting Clinical Trials in India

Comprehensive overview of India's clinical trial regulations, covering key aspects and requirements for conducting ethical and compliant research in the country.

  • Free Online Course

Thinking Critically: Interpreting Randomized Clinical Trials

Enhance critical appraisal skills for evaluating clinical research papers through engaging videos and practical examples. Improve clinical practice, research quality, and peer-review abilities.

  • 1 week, 2-3 hours a week

Design and Interpretation of Clinical Trials

Learn to design, conduct, and interpret clinical trials for evaluating medical interventions. Explore trial designs, randomization, masking, outcome selection, analysis methods, ethical considerations, and reporting standards.

Translating Research to Patients

Explore clinical trials, ethical research practices, and regulatory processes in translating scientific discoveries to patient care. Gain insights into human subjects research and its role in advancing medical knowledge.

  • 6 hours 18 minutes

Clinical Trials Operations

Develop essential skills for designing, managing, and analyzing clinical trials, covering ethics, safety, recruitment, compliance, and reporting standards in healthcare research.

  • 17 weeks, 3 hours a week
  • Paid Course

Design and Conduct of Clinical Trials

Comprehensive guide to designing and conducting clinical trials, covering bias control, trial stages, outcome definition, ethical considerations, and participant recruitment and retention strategies.

  • 4 hours 12 minutes

Clinical Trials Data Management and Quality Assurance

Learn to manage clinical trial data, ensure quality, and maintain integrity through effective collection, organization, monitoring, and quality assurance practices for successful research outcomes.

  • 6 hours 35 minutes

Clinical Trials Management and Advanced Operations

Explore advanced clinical trial management, covering protocol events, regulatory compliance, standardization, transparency, evidence synthesis, and essential study documentation for effective research conduct.

  • 4 hours 58 minutes

Clinical Trials Analysis, Monitoring, and Presentation

Learn advanced skills for clinical trial management, including sample size calculation, statistical monitoring, result reporting, and the analyst's role throughout the process.

  • 4 hours 42 minutes

Data Management for Clinical Research

Learn critical concepts and practical methods for planning, collecting, storing, and disseminating data in clinical research. Covers electronic data capture, regulatory compliance, and best practices for effective data management.

  • 17 hours 25 minutes

Partnering with the Public and Patients in Medical Research

Explore patient-researcher partnerships in medical research, learning strategies for inclusivity, trust-building, and mutual benefit to enhance research outcomes and patient empowerment.

  • 5 weeks, 1-2 hours a week

Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers

Developed by leading researchers and clinicians from across Canada, this course will enhance knowledge and skills for clinicians who are using or beginning to use a biosimilar or biologic medicine in their professional practice setting.

  • 16 weeks, 3-6 hours a week

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About the Clinical Trials Certificate Program

Clinical Trials are a key tool in the evaluation of new strategies for prevention and treatment of disease. This certificate program focuses primarily on the design and analysis of randomized clinical trials for evaluation of licensed and non-licensed medical products and other health interventions, the regulatory framework for the conduct and evaluation of data from clinical trials, and ethical principles for the conduct of clinical trials.

Educational Objectives

After completing the certificate, students will be able to:

  • Summarize the history of clinical trials and describe the role they play in evaluation of health interventions;
  • Explain the key differences, advantages and disadvantages of experimental versus observational study designs;
  • Develop a protocol, consent statement, monitoring plan and data collection plan for a clinical trial;
  • Review and critique manuscripts presenting the results of clinical trials using CONSORT guidelines; and 
  • Explain the key ethical principles regarding the design, conduct and analysis of clinical trials

Curriculum for the Clinical Trials Certificate Program

Please visit our Academic Catalogue to see the full certificate curriculum requirements. Please also review the certificate completion requirements .

Admissions Requirements

Degree students.

The certificate program is open to graduate students currently enrolled in any division of the Johns Hopkins University, with the exception of MAS students, who are not eligible to apply until they have completed their primary degree program. 

Applying to the certificate program as a JHU graduate student:

Applicants who are already enrolled in graduate programs at JHU must submit a short letter of interest and CV/resumé to the Certificate Program Contact, and complete a Declaration of Intent form  prior to starting coursework. 

Eligible Start Terms :

Email Certificate Program Contact

Non-Degree Students

Students with at least a baccalaureate degree from an accredited college or university and a strong academic record are eligible for admission to this certificate program.

1st and 3rd

Applying to the certificate program as a non-degree student:

Applicants who are not currently enrolled in a graduate program at JHU are required to apply to certificate programs using SOPHAS Express . All non-degree applicants should review the general Certificates Admissions page for instructions on how to apply to a certificate program.

Prerequisites or special requirements

Application for Non-Degree Students

Information regarding the cost of tuition and fees can be found on the Bloomberg School's Certificate Programs Tuition page .

Financial Aid Eligibility: U.S. citizens and U.S. permanent residents enrolled in this certificate program may be eligible to apply for Title IV financial aid. Please contact the  JHU Office of Student Enrollment and Account Management (SEAM) for more information.

Questions about the program? We're happy to help.

Sponsoring Departments Epidemiology

Certificate Program Contact Sheila Small [email protected]

Faculty Sponsor Ann-Margret Ervin

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OCRECO Home > Courses > Courses in Clinical Research

OFFICE OF CLINICAL RESEARCH EDUCATION AND COLLABORATION OUTREACH

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Courses in Clinical Research

Principles of clinical pharmacology.

The Principles of Clinical Pharmacology course is a lecture series covering the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The course focuses on the following core principes of pharmacology: pharmacokinetics; drug metabolism and transport; drug therapy and special populations; assessment of drug effects; drug discovery and development; pharmacogenomics and pharmacotherapy.

Introduction to the Principles and Practice of Clinical Research

Clinical research training on-line course for principal investigators (continuous open registration), ethical and regulatory aspects of clinical research.

The Ethical and Regulatory Aspects of Clinical Research course is offered to anyone interested or involved in clinical research involving human subjects.

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Programs in Clinical Research

1 year | full-time, 2 years | part-time, boston university medical campus.

Boston University’s programs in Clinical Research aim to meet the needs of health professionals engaged in the full-spectrum of patient-oriented research. We offer both master’s degree and certificate programs to individuals seeking careers in clinical research in industry or academic settings.

Clinical Research program offerings:

  • Master of Science in Clinical Research (MSCR)
  • Online Graduate Certificate 
  • Dual Degree in Medical Sciences and Clinical Research
  • Dual Degree in Medicine and Clinical Research

About the MS in Clinical Research Program (MSCR)

Located in Boston’s South End at the Boston University Chobanian & Avedisian School of Medicine, the Master of Science in Clinical Research Program (MSCR) has been in existence since 2001 and is ranked #1   by College Choice among universities that offer an MS in Clinical Research.  As an entity of BU CAMED, students are provided with opportunities and are exposed to resources that are part of the Chobanian & Avedisian School of Medicine , the School of Public Health , the Goldman School of Dental Medicine , Boston Medical Center , two VA Administrations, and BioSquare.  All of this offers students endless opportunities for personal, academic and professional development.

The Master’s in Clinical Research program, which is a STEM program, teaches students the scientific fundamentals of human research. Courses in our curriculum provide an in-depth look at all of the key elements in clinical research, including: trial design, trial management, biostatistics, ethical issues, and clinical research regulations. Other courses cover how basic science discoveries translate into clinical research and new therapies. The total course requirement is 32 credit hours: 22 hours are required curriculum, including practicum and research credits; 10 hours are elective courses. Students will also complete a research “practicum”; a hands-on involvement in a clinical research project under a scientific mentor. The final requirement for the degree is to conduct clinical research, write, and present a capstone project.

Who is this program designed for?

The Master’s in Clinical Research program is designed for anyone interested in a career in clinical research. This includes those with MD or PhD degrees interested in becoming independent principal investigators, as well as those with bachelors or masters degrees who seek advancement in a research career in industry or academic settings.

Online Graduate Clinical Research Certificate

If you are not ready to commit to our Master’s program, we also offer an Online Graduate Certificate in Clinical Research.   This certificate program involves 4 courses across two semesters, and can be completed in one academic year.

Learning Objectives

Upon completion of the Master’s in Clinical Research program, students are expected to:

  • Demonstrate the ability to design and conduct clinical research, analyze results and answer a research question.
  • Demonstrate the ability to read and critique the clinical research literature.
  • Present clinical research findings (from literature or their own research) to peers.

Our Mission

Inspire, Instruct, Innovate … The MS in Clinical Research program is dedicated to the discovery, development, and application of knowledge as it pertains to all areas of clinical research. Our mission is to foster an engaging and effective educational environment that promotes the pursuit of outstanding teaching and learning through formal classroom and practical training. With established collaborative relationships with pharmaceutical, biotech, and academic institutions, students are provided with unique opportunities to pursue clinical research in areas that are of personal and professional interest.

We hope that the information you receive about our program encourages you to pursue your graduate degree in clinical research with us. If you are interested, click here to get your application started.

If you would like to visit our campus or have any questions about our program, please contact Stacey Hess Pino at [email protected] . We look forward to meeting and/or speaking with you!

Janice Weinberg, ScD Director, MS in Clinical Research; P rofessor, Department of Biostatistics

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I wanted to progress in my career, as I already was working in the field of clinical research. For me the course was a great experience, I learned a lot. I was able to broaden my knowledge about clinical trials and now

I feel prepared for the interviews and career steps to come! The teachers were extremely good trained and it was a pleasure to learn from them.

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and all the great tutors: Eric Klaver, Gavin Chait and Gabriele Disselhoff.

The VIARES Clinical Research Talent Program provided me a great opportunity to refresh and rebuild my clinical research skills and competencies. The program was well structured and covered the key aspects related to clinical research, drug

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VIARES Academy supported me at every step in my course and answered my questions instantly. Moreover the platform is very organized and I could find my way around very fast.

The course content provided by the courses at VIARES have helped me to improve my knowledge at my current job as a clinical trials assistant.

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ACRP Course Catalog

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How to Make Soft Skills Your Superpower

August 14, 2024—With such an emphasis on the importance of soft skills, this live webinar will provide attendees with tools to assess the maturity of their soft skills.

Contact Hours

Who’s in Charge When AI is Let Loose on Clinical Research?

September 13, 2024—Artificial intelligence (AI) has been touted as holding the solutions to a variety of vexing challenges in healthcare, but is it possible that there’s a downside to integrating what some might call an ungovernable technology into the clinical research arena? This live webinar ponders the issue of who’s making sure this power is being used to benefit everyone fairly.

Action Steps for FDA Diversity Action Plans

September 25, 2024—In this live webinar, industry experts will offer examples of how diversity action plans vary among therapeutic areas — and why one size does not fit all. They also will explain why it’s important to incorporate action plans earlier in the clinical trial process, as well as consequences for failing to follow a submitted plan.

Facilitating Understanding in Informed Consent

October 9, 2024—Have you read the new draft Guidance from FDA for Sponsors, Investigators and IRBs on Key Information and Facilitating Informed Consent? Join this live webinar as our speaker discusses this guidance.

ACRP and the Academy Annual Membership Meeting

October 16, 2024—Join ACRP and the Academy leadership to explore highlights of ACRP’s year and what’s planned for 2025.

NIH Partnering with ACRP to Address Challenges Related to Implementing Trials (ACRP 2024 Recording)

Leaders at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognized that in recent years, a large proportion of National Institutes of Health (NIH) funded clinical trials have not achieved target enrollment within the allotted time or budget, and some have been terminated early for futility.¹ Based on a retrospective review of National Heart, Lung, and Blood Institute (NHLBI) funded trials, only 26% were successfully defined as achieving 100 percent enrollment in the target time allowed.

Deepening Diversity: LGBTQIA+ Diversity in Clinical Research

In this webinar, expert panelists discussed how sponsors can smooth the LGBTQIA+ patient journey for clinical trials, starting with gender-neutral protocols, making trial communication more inclusive, the FDA’s draft guidance on diversity plans and data collection, and the roles that sites/investigators can play.

Merck Journeys: Career Conversations within Clinical Research

Discover the exciting world of clinical research at Merck during this informative event. Hear from professionals from Clinical Data Management, Clinical Science and Study Management, and Clinical Research Associate roles as they discuss their careers, the industry, and their experiences at Merck.

The Future of Home Health Care in Clinical Trials

This session provided insights into the presenters experience with home health visits to-date and prompted site and investigator attendees to understand what works and doesn’t work for sites when offered home health options in trial protocols.

ACRP 2024 Full Program – Replay

A replay package of 86 on-demand session recordings and presentation slides from the ACRP 2024 Conference, May 3 – 6, Anaheim, California. It includes content from the six educational tracks, the Signature Series sessions, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2027.

ACRP 2024 Study & Site Management – Replay

This package is a replay of 26 on-demand session recordings and presentation slides from the Study & Site Management Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Learn practical, proven ways to maximize study and site performance.

ACRP 2024 Regulatory & Compliance – Replay

This package is a replay of 13 on-demand session recordings and presentation slides from the Regulatory & Compliance Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Hear tips and strategies to mitigate risk and keep your studies in compliance.

ACRP 2024 Clinical Trial Design – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Clinical Trial Design Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Explore the fundamental considerations for effective clinical trial design.

ACRP 2024 Leadership & Professionalism – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Leadership & Professionalism Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Get the insights you need to advance your career and grow as a leader.

ACRP 2024 Workforce Development – Replay

This package is a replay of 11 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Understand the workforce landscape and gain strategies to build smarter teams.

ACRP 2024 Technology & Future Trends – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2024 Conference, May 3 – 6, Anaheim, California. Gain strategies to optimize technology and move your studies into the future.

Improving the Understanding of Informed Consent Among Vulnerable Populations

This webinar addressed practical ways stakeholders in research can help improve the creation of ICFs and better the overall process to ensure patients have a fuller understanding of the risks, commitment, and cost of agreeing to participate in a clinical trial.

Employee Development and Succession Planning

This webinar targets site and organizational leaders with the kinds of details they need to pay attention to in order to develop the framework for an employee development program which will support succession planning.

Intro to In Vitro Diagnostics (IVDs): The Path to Working Together Globally and More Efficiently

This webinar addressed the pressing need for standardized regulatory practices in the field. With advancements in in-vitro diagnostics (IVD), an increasingly interconnected global healthcare landscape, and the growing demand for precise diagnostics, the need for harmonized regulations is paramount.

Clinical Trial Process History and Overview

This webinar covered phases of drug development, the history of regulatory development of human research protection, various types of research study designs, conducting a clinical trial, and generic name and trade name of the medicine.

Efficiency Unleashed: Optimizing Clinical Research Onboarding and Education

Clinical trial professionals with an interest or role in the onboarding and education of new staff can learn valuable best practices from the steps taken, barriers encountered, and resources available during one clinical trial site’s journey toward realizing its goal for optimal efficiency.

Building Your Team Through Transformational Leadership in Clinical Research

This webinar challenged attendees to self-reflect on their own leadership practices and how those might have been in need of transformation

ISO 14155 and FDA Requirements – Trials Conducted at the Research Site

This program explored medical devices and investigational medical devices.

Unlearn to Learn: The Evolution of Clinical Research/Trial Training

This session discussed the current way clinical trial training is implemented and ways that it could potentially be done more effectively and efficiently by industry stakeholders.

A Review of Medical Record Data Extraction and Adverse Event Reporting

This informative session explores some of the tools of the clinical research trade including data extraction and adverse event reporting.

Broadening Your Approach to Trial Diversity on a Global Scale

This live webinar explored diversity through a global lens by tapping into the perspectives of industry leaders who addressed how we can broaden access to a wide range of underrepresented groups, including those who possess attributes linked to troubling and challenging health disparities.

Merck Journeys: Elevating your Career within Clinical Research

This webinar offered a unique opportunity to learn about the rewarding career paths in CSSM. Experienced professionals from Merck shared insights into the innovative clinical research strategies, and discussed how your transferable skills can be leveraged in this field.

ACRP Annual Membership Meeting

ACRP and The Academy leadership joined together to explore highlights of the past year and see what was planned for 2024. Attendees heard how ACRP is working for them and the clinical research profession.

Investigator-Initiated Trial Tips and Tricks

This webinar highlighted best practices in various areas of clinical research management of investigator-initiated trials (IITs) and detailed how to navigate common challenges. The information included in this comprehensive review of IIT operations is experience-based and built upon good clinical research practices in alignment with NIH Regulations.

Good Clinical Practice (GCP) Simulation Renewal

The New Standard in GCP Training. This interactive simulation-powered training course helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

Home Study: August 2023

Supplement more rigorous training, stay informed of the latest trends and developments in clinical research, and earn points for Maintenance of Certification with Home Study tests offered through ACRP’s flagship journal, Clinical Researcher.

  • BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Introduction to Decentralized Clinical Trials (DCTs)

Gain the foundational knowledge clinical research professionals need to implement digital health components in clinical trials.

Investigational Drug Services Pharmacists: What They Wish You Knew

How the Investigational Drug Services (IDS) Pharmacy utilized by your clinical trials team works shouldn’t be a mystery, when it can instead be one of your biggest allies in research. This webinar provides “insider insights” from an IDS pharmacist on facts you should have at hand about IDS services when sponsors are considering your site for studies, or are sending monitors to keep track of ongoing projects.

How Do IRBs Review Virtual Trial Technology?

How will institutional review boards (IRBs) review study protocols involving the ever-increasing array of mobile health (mHealth) technologies and virtual trial apps on the market? This webinar helps clinical research professionals to understand the regulations and how the oversight of virtual trials might differ from what they have traditionally been used to.

ACRP 2023 Full Program – Replay

A replay package of 62 on-demand session recordings and presentation slides from the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. It includes content from the five educational tracks, the Signature Series sessions, Rapid-Fire session, and techXpo sessions, presented by a variety of clinical research service providers. Replay sessions will expire on May 31, 2026.

ACRP 2023 Workforce Development – Replay

This package is a replay of 8 on-demand session recordings and presentation slides from the Workforce Development Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Understand the workforce landscape and gain strategies to build smarter teams.

ACRP 2023 Technology & Future Trends – Replay

This package is a replay of 7 on-demand session recordings and presentation slides from the Technology & Future Trends Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Gain strategies to optimize technology and move your studies into the future.

ACRP 2023 Leadership & Career Growth – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Leadership & Career Growth Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Get the insights you need to advance your career and grow as a leader.

ACRP 2023 Regulatory Trends & Compliance – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Regulatory Trends & Compliance Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Hear tips and strategies to mitigate risk and keep your studies in compliance.

ACRP 2023 Study Management & Conduct – Replay

This package is a replay of 17 on-demand session recordings and presentation slides from the Study Management & Conduct Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Learn practical, proven ways to maximize study and site performance.

2022 Site Perceptions Industry Survey Results: Actionable Insights for Sites, Sponsors, and CROs

Site leaders often feel their voices are not heard during the planning and conduct of sponsored clinical trials, while sponsors and contract research organization representatives feel at odds struggling to enhance relationships with those same sites. This webinar focuses on the results of an industry survey conducted by the Tufts Center for the Study of Drug Development on site perceptions, preparedness, and experiences with new clinical research execution solutions, and offers lessons learned on how you can improve site sustainability and lead more effective collaborations.

I Need a Mentor: Where Do I Start?

Career success shouldn’t be measured solely by how far one is able to climb the organizational ladder, especially when reaching career goals depends on so much more than mere effort. In an environment where achievement may rely less on “what you know” than on “who you know,” identifying the right individuals to be part of your knowledge bank and support squad can become crucial.

Building a More Equitable Future Together by Driving Inclusion in Clinical Trials

This webinar targets professionals across the clinical trial ecosystem with best practices learned about taking collective action to drive improvements focused on diversity, equity, and inclusion (DEI) issues. You will learn about building trust within historically underrepresented racial and ethnic minority communities, making clinical trials inclusive by design, and fostering partnership to address DEI-related issues in an integrated and sustainable manner.

Building Clinical Trial Diversity Action Plans for the Future, Now

Dive into the key elements of a diversity action plan for Phase III clinical trials, as explained in the latest recommendations and requirements from the U.S. Food and Drug Administration (FDA), including considerations of race, ethnicity, age, sex, gender, geographic location, and socioeconomic status. Learn how these diversity action plans contribute to the study site’s delivery of meaningful data on drug safety and efficacy from to sponsors.

A Review of ICH E8 (R1) General Considerations for Clinical Trials

The ICH E8(R1) Guideline on General Considerations for Clinical Studies from the International Council for Harmonization guides the clinical development lifecycle for experimental therapies, including quality requirements for clinical study designs and data sources. Principles and practices for the conduct of clinical trials tied to this guideline, already in effect in such regions as the U.S., Canada, and Europe and forthcoming elsewhere, will be reviewed.

Achieving Global Health Equity Through More Diverse and Inclusive Trials

Ensuring a more equitable and accessible healthcare system starts with the healthcare professionals engaged for pre-drug launch and marketing, with the site investigators recruited by sponsors to run clinical trials, and with the location and availability of the study in terms of diverse and underrepresented populations of potential participants. Here’s a historic overview of what has been lacking in clinical trials when it comes to diversity and inclusion, how federal guidelines are beginning to turn the conversation within big pharma toward health equity, and more.

2022 ACRP/Academy Annual Membership Meeting

Join ACRP/Academy leadership to explore highlights of ACRP’s year and what’s planned for 2023 in the areas of membership, certification, and finances.

Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 1): Theoretical Foundations and Core Competencies of Self-Leadership

Learn how to use self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world.

Ensuring Quality in Fast Enrolling Trials

Are new trials coming at you with break-neck speed? This webinar reviews a case study from a fast-enrolling trial and offers strategies for maintaining high quality standards and recognizing and mitigating the risks of accelerated enrollment.

Webinar—Self-Leadership: Winning Strategies for Fulfilling Work and Life (Part 2)

Learn even more about using self-leadership strategies to survive and thrive in today’s volatile, uncertain, complex, and ambiguous world, in part two of this webinar. 

In the DCT Journey, Every Cloud Has a Silver Lining

This webinar focuses on some of the advantages and takeaways learned so far from the introduction, implementation, and adoption of decentralized clinical trials (DCTs). Panelists explore how they operationalized best practices in the areas of budgeting, contract language, remote monitoring practices, virtual visits, and more.

ICH E9: A Review and a Look Into the Addendum (R1)

Dive into an overview of both the ICH E9 Guideline on Statistical Principles for Clinical Trials from the International Council for Harmonization and the ICH E9(R1) Addendum, exploring how clinical trials are based on statistical principles and how treatment effects are measured.

Understanding the Role of DMCs and EACs in Research Oversight

Take a deep dive into the roles and functions of Data Monitoring Committees/Data Safety Monitoring Boards (DMCs/DSMBs) and Endpoint Adjudication Committees/Clinical Events Committees (EACs/CECs) in the lifecycle of clinical trials. These committees are increasingly tasked with providing independent, expert evaluations of clinical trial events and unbiased adjudications to determine if the definitions of certain clinical trial events have been met.

Everything You Need to Know About Holding an IND

This webinar provides a review of the purpose of and expectations set for holding an Investigational New Drug (IND) application through the U.S. Food and Drug Administration, explores common IND-related errors and how to avoid them, and outlines related requirements found in 21 CFR 312 of the Code of Federal Regulations for IND maintenance.

Deconstruct Your Clinical Trial to Plan a Positive Outcome: Effective Planning and Communication Strategies

This webinar examines the communication of intent and expectations to stakeholders in clinical trials to minimize risk and gain fluidity in operations, along with key elements behind planning a clinical trial and best practices for budgeting a study.

Streamline Your Clinical Research Organization’s Processes with End-to-End Promotions

Presenting a discussion on how consolidating the processes involved in the phases of drug discovery, pre-clinical research, clinical trials, and post-approval expectations on a single platform drives efficiencies, margin improvements, and real-time collaborations internally and externally. The result is better top- and bottom-line financial performance and consistency in process outcomes during trial execution.

Best of ACRP 2022

The “Best of ACRP 2022” package offers recordings from 25 of the most popular sessions from our most recent in-person event, along with seven techXpo sessions, presented by a variety of clinical research service providers.

Eliminating Barriers to Careers in Clinical Research

A perfect storm of negative trends is putting immense pressure on entry-level hiring, retention, and overall satisfaction and growth in the clinical research workforce. This webinar focuses on recognizing and overcoming the challenges that are unnecessary barriers to greater participation in the workforce by promising talent from a range of backgrounds and experiences.

The New Work Life Balance in Clinical Research

There’s no denying that “work as usual” has gone out the window in recent years–in the clinical research workforce as well as in most other settings. This webinar explores strategies for juggling a career in clinical research and your personal life in the “new normal,” including in the arenas of excelling at time management in the office and at home, reaching an ideal work/life balance, and acquiring tools to help make your goals a reality.

Investigative Site Diversity: Tufts CSDD Study on Staff Diversity at Clinical Research Sites

In this webinar, the Tufts Center for the Study of Drug Development team shares survey results on staff diversity at clinical research sites, with an emphasis on the impact diversity has on site performance and its practical implications, the major factors noted for diversity-related success and their associated barriers, and the relationship between site diversity and patient diversity.

The Push for Technology: A Discussion of Implementation Struggles, Strategies, and Lessons Learned

This webinar features a panel discussion on how the pandemic pushed the implementation of new technologies for clinical trials, with a site-centric focus on the struggles overcome and lessons learned, along with the impact on the workforce and how we all may want to prepare for the future.

Best Practices for Communicating Benefit, Risk, and Uncertainty in Medical Device Clinical Trials

This webinar focuses on how research participants cannot make an informed decision to participate in a clinical trial without clear communications from the research professionals supporting the trial. Evidence-based practices are covered to help you conduct patient education and informed consent tied to the benefits, risks, uncertainties, and patient preferences for using new medical technologies.

Using Agile Strategies to Solve Challenges in Research Operations

This webinar looks at how being agile in research settings is becoming a key performance indicator that partners and sponsors are seeking and expecting from sites, with a focus on techniques and strategies you can use to address and solve administrative and operational challenges at a faster rate via pragmatic and thoughtful “big swings of bold.”

Clinical Research Staffing Reprioritizations and Resourcing Strategies

This webinar presents lessons learned from a survey on the impacts of the pandemic on staffing at research sites, and discusses implications for the future of clinical research workflows from the current shift to remote operations. When should you look for help or change your staffing approach?

The Future of DCTs: Are You Prepared?

This webinar is tailored for research professionals in sponsor, contract research organization, and study site settings who wonder how to embrace the challenges and benefits of decentralized clinical trials (DCTs), and includes a practical guide for what DCTs really are, how there is no going back, and how it is up to the research professional to adapt to change.

Research Ready: Leveraging Technology in the New Research Landscape

Join Advarra experts in a discussion on how to leverage technology in the new research landscape

Working with Site-Based Paperless Solutions and Ensuring Audit Readiness

Join RealTime experts for an overview of site-based electronic systems that the research industry is rapidly adopting.

Achieving Regulatory Compliance via Collaboration: Technology and Site Perspectives

Join experts from WCG Velos and the University of Kansas Medical Center to learn top practices and processes sites follow to meet compliance standards.

Communication Strategies for Conflict Resolution in Clinical Research Teams

This webinar examines group dynamics, team function, and how conflicts arise within the research team, and considers how specific communication behaviors can foster effective conflict resolution that facilitates team growth.

Career Paths in Clinical Research: Sharing the Journey and Providing Insight

Join a panel of clinical research professionals as they discuss their career paths into and through the clinical research industry, consider the future of their roles, and share advice with those wanting to join the industry. You will gain an understanding of the different research roles, areas that are ripe for career growth and development, and how you can prepare to thrive amidst future trends.

Good Clinical Practice (GCP) Simulation

Informed consent simulation.

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

ACRP Clinical Research Knowledge Assessment™ (CRKA)

Whether you’re an emerging professional looking to demonstrate your foundational knowledge to prospective employers or an organizational leader looking for an efficient, effective way to vet new hires, ACRP’s new Entry-Level Knowledge Assessment (ELKA) is for you.

Certified Quality Manager Training

Increase your influence and expand your career opportunities by validating your commitment to quality. The Quality Management Institute and ACRP have partnered in a program of education for individual professionalism and the quality management of clinical research sites.

  • BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, PMs, QCS, RS, RM, RTA, SSSU, Statistician, , Trainer

Clinical Trial Monitoring Basics

Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?

  • Entry Level , Intermediate
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Ethics and Human Subject Protection: A Refresher Course

When in need of a comprehensive refresher, this on-demand eLearning course provides a consolidated overview on the history and importance of ethical conduct in clinical trials involving human subjects.

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Investigator Responsibilities

Learn the various responsibilities of clinical investigators based on FDA Regulations, ICH Guidance Documents, and international standards.

Improving Recruitment, Accrual, and Retention in Clinical Trials

Explore best practices to improve recruitment and retention with a focus on operational efficiency, cultural competency, and patient centricity. Included tools will help you assess how to better communicate with potential participants and begin a critical reflection of your own skills and organizational practices.

Trial Feasibility and Selection: Their Impact on Accrual

Selecting the right trial for your clinical research site is key to the success of your accrual for the trial. This eLearning course will discuss how the menu or portfolio of studies offered at a site has an important impact on accrual and how research professionals can become part of the process.

  • CRC, CRN, Investigator, PR, RM

Implementing a Patient-Centered Informed Consent Process

Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.

Using Metrics to Improve Subject Recruitment and Retention

Overcome challenges in subject recruitment and retention by learning how to leverage the metrics critical to success. This eLearning course will teach site personnel assess current site performance and readiness for action, and to implement appropriate metric measurement and monitoring.

  • BCO, BD, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, FA, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Introduction to Clinical Trials

Fundamental education about the role clinical research plays in advancing medical knowledge and the work conducted by clinical research professionals. This free eLearning course details how medical products are developed, how volunteer patients are protected, and key roles in the development, research, review, and approval of medical products.

  • Intermediate , Senior

Site Quality Management Tools: SOPs, Metrics and Training

Master quality-related processes and procedures required to ensure trial compliance. This eLearning course is a comprehensive training program that prepares you for the next step of setting up a quality management system– essential information for site personnel involved in quality management and improvement.

  • BCO, CDC, CRC, CRN, CRS, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

Reduce your anxiety by being prepared for clinical trial inspections. This eLearning course takes you through the full cycle of a regulatory authority GCP inspection and answers key questions including: Why, when and where are regulatory inspections performed? Who can be inspected? And more.

Mastering the Event Reporting Cycle: Understanding Adverse Events (AEs)

Efficiently identify and report safety events in your clinical trials. This eLearning course, appropriate for all clinical research professionals, guides you through the complete event reporting cycle and critical timelines, as defined in ICH E2a and E6 Guidelines.

  • BCO, BD, CDC, CRC, CRN, CRS, DM, Investigator, MA, MD, MRS, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review

Expand your knowledge and skills in study protocol design and review. This e-Learning course covers the anatomy of a protocol, hypothesis development, study design, subject safety and data integrity risk considerations, protocol feasibility and protocol amendments.

Statistical Principles for Clinical Trials: Overview of ICH E9

Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data. This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials.

  • BCO, CRC, CRN, DMCTO, Executive, FA, Investigator, MCRA, PMs, RM, RTA, SSSU, Trainer

Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense

An essential course for all clinical research professionals involved in the clinical trial agreement and/or budget process for industry-initiated trials.

Risk-Based Decisions: Key Skills for Ensuring Quality Control

Gain confidence in making risk-based decisions and implementing actions related to quality control initiatives. This eLearning course covers key aspects related to risks in clinical trials, including: identification, analysis, planning, communication, change management and much more.

  • CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Investigator, MA, MD, MRS, MSO, MW, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Statistician, Trainer

ICH Gap Analysis

Assess your and your team’s training needs quickly by conducting an ICH gap analysis. This eLearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines.

  • Investigator, MCRA, PMs

Form FDA 1572: Get it Right the First Time

The Statement of Investigator (Form FDA 1572) doesn’t have to be complicated – let us help you get it right the first time. This eLearning course answers the questions of why, when and how to complete the FDA 1572 to make everyone’s jobs easier.

Ethics and Human Subject Protection: A Comprehensive Introduction

Explore the ethical considerations facing clinical research professionals and learn to put the rules into practice to ensure human subject safety and well-being. This eLearning course provides in-depth training on the importance of ethical conduct in clinical trials involving human subjects.

The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials

Develop a better understanding of the overall drug development process and how each study fits into the “big picture” of the development life cycle. This eLearning course puts into practice the ICH E8 guidance document General Considerations for Clinical Trials.

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance. This eLearning course will teach you risk management strategies to avoid inaccurate trial data, regulatory non-compliance and more.

  • BCO, CDC, CRC, CRN, CRS, CTMS Admin, DM, DoP, DoSA, DMCTO, DMRA, DSM, DSP, Executive, Investigator, MA, MD, MRS, MSO, MCRA, PR, Pharmacist, PMs, QCS, RS, RM, RTA, SSSU, Trainer

eResearch: Managing Clinical Trials in an Electronic Environment

Learn how to set up and manage electronic clinical research documents in compliance with U.S. and EU regulations, and current trends from both the site and sponsor perspectives. This eLearning course examines the challenges of working with electronic documents and how to overcome them.

Clinical Research Fastrack

Start Your Clinical Research Career. Advance Faster. Empower Your Team.

Accelerated online clinical research training courses..

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Learn the day-to-day skills and best practices of a Clinical Research professional.

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Receive career coaching that will prepare and support you as you enter the Clinical Research industry.

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Become a part of a global initiative to advance medical innovation and impact patients lives.

With accelerated training, mentoring, and career coaching you can develop the necessary skills, not only to get hired in Clinical Research quickly but also to advance faster and build a thriving career. Training can be completed online in under six weeks.

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Read Student Reviews

Hear what former graduates from all backgrounds have to say about their training experience at Clinical Research Fastrack.

I hope this message finds you well! I want to express my deep gratitude for your invaluable support and guidance throughout my job search. I am thrilled to share the news that I have successfully landed a job at James J. Peters VA Hospital in the Bronx, and I couldn't have done it without your expertise and encouragement. Your insights into the job market, your advice on crafting a compelling resume and cover letter, and your coaching on interview techniques were instrumental in helping me secure this position. [...] I look forward to staying in touch and updating you on my progress in this new role. Please let me know if there is anything you need from my end as well. I am always looking to learn more and go further in this career path so any resource, guidance, or opportunities would be greatly appreciated.

I want to send my sincere thank you to the entire team at Clinical Research Fastrack. Your dedication and constant support to our class was amazing. I went into this course with no specific expectations of what it would be like, and I was blown away with the classroom experience. With all of my new education, it is now clear to me why I was not the best candidate for jobs I have previously applied to. I have also learned that I was not presenting myself and the skills I bring effectively. These realizations are an important step in the growth I have and need to continue making for success in this industry. I know that I still have a lot of work to do but I feel encouraged and hopeful about the future. I wish you all the very best and I hope you too pursue the goals and dreams of your own lives.

Fastrack is exceptional and amazing. To be honest I never expected this high quality support and training from all the Instructors. This is more than just training. I think its the drive to see someone getting better and getting what he/she desires. Thank you David and Team.

Lauren!!! I'm reading my first protocol to prep for my first SIV next week! My manager and team are amazing and I already am loving this job 🙂 I did a ton of online trainings these past two weeks and honestly CRF was a better / much more engaging way for me to learn all this stuff and have it actually stick. Just wanted to send my many thanks to you and the CRF team again

Lauren T-W.

Hello David and Julia,I trust all is well and more people are getting enrolled in clinical trials training to make the world a better place! I am currently in Rwanda where I am contributing to shape the national clinical research enterprise, and I have to say I am so glad I took the CRC course. The Clinical Research Fast Track helped me understand how the industry functions and with further reading, I am able to provide informed guidance to the national team enhancing the clinical trials environment/ecosystem. This note is to thank you and may be if need arise, I may reach out for support in local training!Kind regards, Kathy

Had an amazing experience with fastrack. The boot camp was very engrossing. The speakers each one of them were so much full of motivation and openness to share their experiences. All in all a very good programme to be in.

An outstanding Clinical Research Training experience! I am an IMG and was wondering on how I could grow my career within the U.S. with my previous medical experience. Throughout this course I gained confidence about my medical knowledge and learned different ways that I can be a great asset within the Research Community. The interactive classes were absolutely empowering. You get the chance to give your intake about different topics. There was always a positive energy throughout the entire course. Besides gaining knowledge about how clinical trials are conducted I but also gained an amazing mentorship that helped me out to obtain an amazing position within the Clinical Research community.

I really recommend Clinical Research Fastrack to anyone who is trying to get into clinical research and do not know where to start. I have been applying for entry level jobs in research for the past two years, getting interviews but couldn't ace them because I did not know the lingo of clinical research. This gives you a broad overview and will prepare you for those interviews!The team is amazing, they are so very kind and are there for you every step of the way!

The best decision i ever made was enrolling with Clinical Research fastrack. As a Graduate nurse, my wish is to move forward into a fulfilling career that will allow me improve on my skills and applicable knowledge.Clinical Research gave me the require foundation to start working confidently in the field as Clinical Research Analyst. what stood out to me ,was the dedication, commitment and positive learning environment as well as insightful guidance from all the instructors. CRF is the best!

Designed with careers in mind, our industry-leading courses have helped hundreds of aspiring Clinical Research professionals begin rewarding careers in this field.

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Lives changed through clinical research, i've hired multiple clinical research fastrack graduates and each one has been highly motivated, well-trained, and thoroughly prepared for success in this field., kenyetta sims, our career mentors specialize in you., become a diversity partner.

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Home   >   Education & Training  > Essentials of Clinical Research Course

Essentials of Clinical Research Course

The Essentials of Clinical Research course is designed for Stanford and CTSA-affiliated faculty and staff engaged in clinical research and consists of 10 sessions. 

Email our Education & Training team

Registration for 2024 On-Demand Essentials of Clinical Research will be available starting June 1.

Register Here

2025 LIVE Course Thursday, 4 – 6pm, Jan. 10- Mar. 21, 2025

This course provides an overview of basic principles of clinical research design, including biostatistics; study design and interpretation of diagnostic and predictive test studies; and required and desired elements of clinical trial protocols. Participants will be introduced to the regulatory aspects of clinical research conduct and oversight, Good Clinical Practice (GCP) principles, and ethical dimensions of clinical research.

Course Details

The On-Demand Essentials of Clinical Research will be available starting May 6, 2024. These are the recorded seminars from Jan – Mar 2024. This information is for learning purposes only. An evaluation is requested at the end of the course. Presentations and resources are available. A certificate will not be issued.

Registration open for the 2024 Essentials of Clinical Research  The course will be held in person with zoom option for our out-of-state participants. Note, the course takes place from 4:00 – 6:00p pacific time. While the course is recorded for course participant viewing, participants should plan to attend the LIVE sessions. Enrolled participants may be dropped from the course if there are more than 3 absences. Please complete the knowledge tests and evaluations within the allotted time frame to receive a course completion certificate, and CME credit, if offered. Continuing Medical Education (CME) credit is applicable towards clinician and nurse license renewals. 

Find Syllabus here

Faculty Director

Steve Goodman, MD, MHS, PhD Professor (Epidemiology and Population Health) Associate Dean of Clinical and Translational Research

Certification of Completion (Live Course)

A Certificate of Completion is available to those who meet the following requirements:

  • Attend a minimum of 8 sessions
  • Complete a minimum of 8 session evaluations
  • Take post-course knowledge assessment  

Essentials of Clinical Research Course Syllabus

Sessions are taught by Stanford faculty and staff who are experts in the field of clinical research.

Upon course completion, attendees will have an understanding of how to:

  • Design and analyze clinical research protocols.
  • Comply with “Good Clinical Practice” guidelines for study conduct, data management, and relevant regulations.
  • Apply the principles and practices underlying ethical and reproducible research.

If you have any questions, please contact Research Office Training 

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    Registration open for the 2024 Essentials of Clinical Research The course will be held in person with zoom option for our out-of-state participants. Note, the course takes place from 4:00 - 6:00p pacific time. While the course is recorded for course participant viewing, participants should plan to attend the LIVE sessions.

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