Vanderbilt University

Data Management for Clinical Research

Vanderbilt University

Data Management for Clinical Research

Stephany Duda, PhD
Paul Harris, PhD

Instructors: Stephany Duda, PhD

Access provided by Signature Performance, Inc.

141,943 already enrolled

Gain insight into a topic and learn the fundamentals.

1,881 reviews

Beginner level
No prior experience required
Flexible schedule
2 weeks at 10 hours a week
Learn at your own pace
94%
Most learners liked this course
Gain insight into a topic and learn the fundamentals.

1,881 reviews

Beginner level
No prior experience required
Flexible schedule
2 weeks at 10 hours a week
Learn at your own pace
94%
Most learners liked this course

What you'll learn

  • How to collect and manage data for clinical research studies  

  • How to build an Electronic Data Capture (EDC) instrument using REDCap software  

Details to know

Shareable certificate

Add to your LinkedIn profile

Assessments

9 assignments¹

AI Graded see disclaimer
Taught in English

See how employees at top companies are mastering in-demand skills

 logos of Petrobras, TATA, Danone, Capgemini, P&G and L'Oreal

There are 6 modules in this course

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.

What's included

6 videos1 reading2 assignments

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.

What's included

9 videos1 assignment1 discussion prompt

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.

What's included

9 videos1 assignment1 discussion prompt

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.

What's included

9 videos2 assignments1 discussion prompt

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.

What's included

12 videos1 assignment1 discussion prompt

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.

What's included

7 videos2 assignments

Instructors

Instructor ratings
(615 ratings)
Stephany Duda, PhD
Vanderbilt University
1 Course141,943 learners
Paul Harris, PhD
Vanderbilt University
1 Course141,943 learners

Offered by

Why people choose Coursera for their career

Felipe M.

Learner since 2018
"To be able to take courses at my own pace and rhythm has been an amazing experience. I can learn whenever it fits my schedule and mood."

Jennifer J.

Learner since 2020
"I directly applied the concepts and skills I learned from my courses to an exciting new project at work."

Larry W.

Learner since 2021
"When I need courses on topics that my university doesn't offer, Coursera is one of the best places to go."

Chaitanya A.

"Learning isn't just about being better at your job: it's so much more than that. Coursera allows me to learn without limits."

Learner reviews

  • 5 stars

    79.53%

  • 4 stars

    17.33%

  • 3 stars

    1.64%

  • 2 stars

    0.63%

  • 1 star

    0.85%

Showing 3 of 1881

AA

Reviewed on Aug 4, 2024

JL

Reviewed on May 15, 2019

MG

Reviewed on May 27, 2019

Explore more from Health

¹ Some assignments in this course are AI-graded. For these assignments, your data will be used in accordance with Coursera's Privacy Notice.