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Vanderbilt University

Data Management for Clinical Research

Vanderbilt University via Coursera

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Overview

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This course presents critical concepts and practical methods to support planning, collection, storage, and dissemination of data in clinical research. Understanding and implementing solid data management principles is critical for any scientific domain. Regardless of your current (or anticipated) role in the research enterprise, a strong working knowledge and skill set in data management principles and practice will increase your productivity and improve your science. Our goal is to use these modules to help you learn and practice this skill set. This course assumes very little current knowledge of technology other than how to operate a web browser. We will focus on practical lessons, short quizzes, and hands-on exercises as we explore together best practices for data management.

Syllabus

  • Research Data Collection Strategy
    • This introductory module orients learners to the course and defines the scope of data management in clinical research. It introduces core concepts such as clinical research, clinical trials, observational studies, IRB review, and data collection instruments, then presents practical best practices for planning research data collection, structuring variables, choosing data collection approaches, documenting procedures, and protecting data quality and confidentiality.
  • Electronic Data Capture Fundamentals
    • This module introduces foundational concepts in electronic data capture for clinical research, including standardizing study processes, selecting and using validated instruments, understanding data standards and terminology, recognizing key regulatory considerations, and identifying essential features of electronic data capture systems such as REDCap. It focuses on how these elements support compliant, efficient, and high-quality data collection and management.
  • Planning a Data Strategy for a Prospective Study
    • This module examines how to plan a data strategy for a prospective research study by translating study procedures into structured, measurable data elements and organizing them into forms for electronic data capture. Using a real-world study example, it emphasizes identifying baseline and visit-level variables, accounting for confounding factors and exclusion criteria, and preparing an EDC workflow that supports accurate and consistent data collection.
  • Practicing What We've Learned: Implementation
    • This module focuses on implementing a prospective study in REDCap by building visit-level forms, configuring longitudinal events and user roles, using shared library instruments, and testing the project before launch. It also introduces essential mid-study data processes, including managing study changes, supporting interim reporting and safety monitoring, and conducting data quality assessment and auditing to maintain complete, accurate, and usable research data.
  • Post-Study Activities and Other Considerations
    • This module examines key post-study data management activities, including study closeout, record retention, data destruction, and sharing research results, methods, and data. It also introduces practical approaches to de-identifying research data, explores healthcare information systems and neuroimaging data sources used in research, and addresses data management considerations for multi-center studies, global research, mHealth, and resource-limited settings.
  • Data Collection with Surveys
    • This final module focuses on collecting research data through surveys by covering survey design principles, questionnaire development, testing, administration, and analysis. It also demonstrates how to build, test, distribute, and review a survey project in REDCap, helping learners translate survey design decisions into practical data collection workflows.

Taught by

Paul A. Harris, Stephany Duda and Firas Wehbe

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Reviews

4.2 rating, based on 5 Class Central reviews

4.7 rating at Coursera based on 1882 ratings

Start your review of Data Management for Clinical Research

  • Profile image for Bruce Thompson
    Bruce Thompson @Bruce
    25
    This course was a great introduction to making electronic forms and surveys. Very practical and based on the ubiquitous REDCap. I thoroughly recommend this course to anyone beginning a career that involves collecting clinical data electronically.
  • Anonymous
    Sir,
    I am very happy to see vedio about clinical data management course .ihave done P G in advance clinical research from Guj.Uni. Ahmedabad Gujarat - india,completed last 2012.
    I have more than 34 + year experience as a senior pharmacy manager.
    I am interested to join this course free online.
    Please guid me.

    Regards,
    JAYSHRIKRISHNA KHATRI
    [contact details detracted]
  • Abdiqani
    8
    I am take this course for understanding the clinical management in the future
    because I interest the issues related with the management of the hospitals .
  • Anonymous
    I medical doctor , graduate from Amoud university for five year ago
    I work on ministry of health in Somaliland
    With highly committed on going studying with exceptional institutions like this ,university university.
  • Phoeun Chandara
    1
    I would like to study this course because it is vitally important to me for my future work and I would like to improve my capacity as well.
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