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.
This introductory module reviews the course structure and basic concepts in clinical research. We also discuss best practices for designing your clinical research data collection.
This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.
What's included
9 videos1 assignment1 discussion prompt
Show info about module content
9 videos•Total 130 minutes
Standardization of Study Processes•15 minutes
Validated Instruments•14 minutes
Data Standards: What Can Standards Do for You?•16 minutes
Data Standards: Basic Concepts and Overview•16 minutes
IRB, HIPAA, and FISMA•14 minutes
GCP and 21 CFR Part 11•11 minutes
Introduction to Electronic Data Capture (EDC)•18 minutes
EDC Concepts: Data Exports, Logging, User Rights, Project Creation•12 minutes
EDC Concepts: Data Imports, Scheduling, Reports, Internationalization•15 minutes
1 assignment•Total 30 minutes
Quiz 2•30 minutes
1 discussion prompt•Total 10 minutes
What standards have you used?•10 minutes
Planning a Data Strategy for a Prospective Study
Module 3•2 hours to complete
Module details
This module reviews the process of planning data elements for a real-world research study.
What's included
9 videos1 assignment1 discussion prompt
Show info about module content
9 videos•Total 91 minutes
Overview of the Study•10 minutes
Study Procedures•10 minutes
Baseline Data and Demographics•14 minutes
Visit Data•6 minutes
Review of Variables and Forms•9 minutes
Logging in to REDCap•2 minutes
Walkthrough: Creating a Project and Adding the First Variables•16 minutes
Walkthrough: Adding Fields to the Baseline Form•13 minutes
Walkthrough: Adding File Fields and Formatting•10 minutes
1 assignment•Total 30 minutes
Quiz 3•30 minutes
1 discussion prompt•Total 10 minutes
How have you assembled a study data management plan?•10 minutes
Practicing What We've Learned: Implementation
Module 4•4 hours to complete
Module details
This week, we set up an Electronic Data Capture (EDC) instrument in REDCap for the Morphine vs. Marinol Study. We also review data processes that occur during the running of a study, including an overview of key data quality operations.
Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights•17 minutes
Walkthrough: Testing the REDCap Project•8 minutes
Example Study Wrap-Up•3 minutes
Mid Study Activities 1•12 minutes
Mid Study Activities 2•15 minutes
Data Quality•12 minutes
Data Quality Monitoring•15 minutes
1 assignment•Total 30 minutes
Quiz 4•30 minutes
1 peer review•Total 120 minutes
Assignment 2 - First REDCap Assignment•120 minutes
1 discussion prompt•Total 10 minutes
What data quality challenges have you encountered?•10 minutes
Post-Study Activities and Other Considerations
Module 5•3 hours to complete
Module details
In this week, we cover activities to wrap up your study and share data and results, as well as two lectures on other electronic sources of data that can be used in research. In response to learner requests, we've also added several lectures on clinical data management in resource-limited settings, in collaboration with research colleagues from Indiana University. This is a long week of videos, but next week will be short on videos in exchange!
What's included
12 videos1 assignment1 discussion prompt
Show info about module content
12 videos•Total 149 minutes
Wrapping Up Your Study•9 minutes
Sharing Your Work•13 minutes
De-identifying Data•9 minutes
De-identifying Dates•13 minutes
Common Information Systems Used in Health Care•13 minutes
Neuroimaging Data Management•16 minutes
mHealth in Developing Countries•19 minutes
Data Management for Multi-Center or Network Studies•11 minutes
Resource-Limited Settings and Global Health•14 minutes
Challenges of Collecting Data in Resource-Constrained Settings•13 minutes
Data Privacy in Global Research•12 minutes
International Data Sharing•8 minutes
1 assignment•Total 30 minutes
Quiz 5•30 minutes
1 discussion prompt•Total 10 minutes
What health care information systems have you worked with?•10 minutes
Data Collection with Surveys
Module 6•4 hours to complete
Module details
In the final week, we cover how to collect data using surveys and review an example together. This week's assignment includes designing, distributing, and reporting on your own survey.
Vanderbilt University, located in Nashville, Tenn., is a private research university and medical center offering a full-range of undergraduate, graduate and professional degrees.
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AA
5·
Reviewed on Aug 4, 2024
The course is very informative and interactive. some questions popping up in between the lectures, really kept me alert. The REDcap tool is also very good and working on it felt like a accomplishment
R
RD
5·
Reviewed on Dec 6, 2020
Instructors were very good. I actually enjoyed my learning. I really appreciate the efforts in building this course. Looking forward for more such relevant courses from Vanderbilt University.
V
VN
5·
Reviewed on Nov 9, 2024
Very detailed lecture with hands-on experience in one of the software for managing clinical research - REDCap
Thanks to the team of lecturers that delivered this masterpiece.
What will I actually learn in this clinical data management course?
You'll learn how study data are planned, collected, managed, and shared in clinical research, and why those choices affect data quality and trust in the results. It starts with core research and data collection decisions, then moves into electronic data capture, compliance, and what happens to data during and after a study. You'll also practice by reviewing form design and building data collection instruments for example studies.
Do I need any clinical research or REDCap background?
No, you don't need prior clinical data management or REDCap experience to start. The course assumes very little technical knowledge beyond using a web browser, and it introduces key clinical research ideas along the way. You'll use REDCap during the course, but the lessons walk you through logging in, creating projects, and adding fields step by step.
Is this course beginner-friendly for clinical data management?
Yes, it's beginner-friendly if you're new to clinical data management and want a guided introduction. The course uses short lessons, quizzes, and hands-on exercises to explain the basics of study planning, data collection, compliance, and data quality without assuming advanced technical skills. It's especially well suited to people working in or entering clinical research, since the examples stay grounded in real study workflows.
How long does it take to complete this course?
Expect about 20 hours in total, which is roughly two weeks at about 10 hours a week. The pace is manageable because the work is spread across lessons, readings, quizzes, and applied assignments instead of one continuous build. The course includes guided walkthroughs, peer-reviewed assignments, and quizzes, so steady weekly progress tends to work well.
Are there hands-on exercises or projects in this course?
Yes, there is meaningful hands-on work, but it's mostly guided rather than open-ended. You'll build electronic data capture instruments in REDCap, test study forms, critique a poorly designed survey, and create a de-identified survey of your own. That practice helps you apply each idea as you learn it, instead of only reading about clinical data workflows.
What topics are covered in this clinical data management course?
The course covers the main parts of clinical research data management, from planning variables and collection methods to organizing forms and study procedures. It also looks at standards, regulatory compliance, data quality, de-identification, data sharing, and survey-based data collection. Overall, you'll see how good data management supports a study from setup through close-out.
What can I actually do after finishing this course?
After finishing, you should be able to plan a basic data collection strategy for a clinical study and make better decisions about how data should be captured and organized. You'll also be able to build or review simple REDCap forms, spot common data quality issues, and understand core compliance and privacy considerations. For example, you could outline baseline and visit forms for a prospective study or design a cleaner survey for participant data collection.
Is this course more theory or hands-on?
It's more concept-first than project-heavy, with guided practice throughout. The course spends a lot of time explaining why good data planning, compliance, and quality matter, then reinforces that through walkthroughs, quizzes, and assignments.
Why choose this course over other clinical data management courses?
This course stands out if you want clinical data management taught across the life of a study, not just as software training or a rules overview. It connects study planning, form design, electronic data capture, mid-study data quality work, and post-study sharing and de-identification in one continuous learning flow. If you want a beginner-level course that stays practical and closely tied to real clinical research tasks, this is a strong fit.