Data Management for Clinical Research

Data Management for Clinical Research

Instructors: Stephany Duda, PhD

140,955 already enrolled

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6 modules

Gain insight into a topic and learn the fundamentals.

1,868 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

6 modules

Gain insight into a topic and learn the fundamentals.

1,868 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

Skills you'll gain

Tools you'll learn

Electronic Data Capture (EDC)

Details to know

Shareable certificate

Add to your LinkedIn profile

Assessments

6 assignments¹

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Taught in English

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There are 6 modules in this course

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.

What's included

6 videos1 reading1 assignment1 peer review1 discussion prompt

6 videosTotal 69 minutes

How the Course Works7 minutes
Course Introduction6 minutes
Defining the Space10 minutes
Research Data Planning 113 minutes
Research Data Planning 224 minutes
Approaches to Data Collection8 minutes

1 readingTotal 10 minutes

Course Logistics10 minutes

1 assignmentTotal 30 minutes

Quiz 130 minutes

1 peer reviewTotal 120 minutes

Assignment 1 - Survey Question Critique120 minutes

1 discussion promptTotal 10 minutes

What is your background in this area?10 minutes

This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.

What's included

9 videos1 assignment1 discussion prompt

9 videosTotal 130 minutes

Standardization of Study Processes15 minutes
Validated Instruments14 minutes
Data Standards: What Can Standards Do for You?16 minutes
Data Standards: Basic Concepts and Overview16 minutes
IRB, HIPAA, and FISMA14 minutes
GCP and 21 CFR Part 1111 minutes
Introduction to Electronic Data Capture (EDC)18 minutes
EDC Concepts: Data Exports, Logging, User Rights, Project Creation12 minutes
EDC Concepts: Data Imports, Scheduling, Reports, Internationalization15 minutes

1 assignmentTotal 30 minutes

Quiz 230 minutes

1 discussion promptTotal 10 minutes

What standards have you used?10 minutes

This module reviews the process of planning data elements for a real-world research study.

What's included

9 videos1 assignment1 discussion prompt

9 videosTotal 91 minutes

Overview of the Study10 minutes
Study Procedures10 minutes
Baseline Data and Demographics14 minutes
Visit Data6 minutes
Review of Variables and Forms9 minutes
Logging in to REDCap2 minutes
Walkthrough: Creating a Project and Adding the First Variables16 minutes
Walkthrough: Adding Fields to the Baseline Form13 minutes
Walkthrough: Adding File Fields and Formatting10 minutes

1 assignmentTotal 30 minutes

Quiz 330 minutes

1 discussion promptTotal 10 minutes

How have you assembled a study data management plan?10 minutes

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.

What's included

9 videos1 assignment1 peer review1 discussion prompt

9 videosTotal 99 minutes

Walkthrough: Creating Visit Forms8 minutes
Walkthrough: Copying Variables, Renaming Forms8 minutes
Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights17 minutes
Walkthrough: Testing the REDCap Project8 minutes
Example Study Wrap-Up3 minutes
Mid Study Activities 112 minutes
Mid Study Activities 215 minutes
Data Quality12 minutes
Data Quality Monitoring15 minutes

1 assignmentTotal 30 minutes

Quiz 430 minutes

1 peer reviewTotal 120 minutes

Assignment 2 - First REDCap Assignment120 minutes

1 discussion promptTotal 10 minutes

What data quality challenges have you encountered?10 minutes

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

12 videosTotal 149 minutes

Wrapping Up Your Study9 minutes
Sharing Your Work13 minutes
De-identifying Data9 minutes
De-identifying Dates13 minutes
Common Information Systems Used in Health Care13 minutes
Neuroimaging Data Management16 minutes
mHealth in Developing Countries19 minutes
Data Management for Multi-Center or Network Studies11 minutes
Resource-Limited Settings and Global Health14 minutes
Challenges of Collecting Data in Resource-Constrained Settings13 minutes
Data Privacy in Global Research12 minutes
International Data Sharing8 minutes

1 assignmentTotal 30 minutes

Quiz 530 minutes

1 discussion promptTotal 10 minutes

What health care information systems have you worked with?10 minutes

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.

What's included

7 videos1 assignment1 peer review1 discussion prompt

7 videosTotal 73 minutes

Benefits, Scope, and Validated Instruments12 minutes
Survey Design14 minutes
Survey Procedures and Implementation12 minutes
Survey Testing, Administration, and Analysis11 minutes
Survey Overview and REDCap Setup12 minutes
Survey Testing and Distribution11 minutes
Thank you for participating!1 minute

1 assignmentTotal 30 minutes

Week 6 Quiz30 minutes

1 peer reviewTotal 120 minutes

Assignment 3 - Build, Deploy, and Report on a Survey120 minutes

1 discussion promptTotal 10 minutes

Share Assignment 3 survey links (optional)10 minutes

Instructors

Instructor ratings

(613 ratings)

Stephany Duda, PhD

Vanderbilt University

1 Course140,955 learners

Paul Harris, PhD

Vanderbilt University

1 Course140,955 learners

Offered by

Vanderbilt University

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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.

Reviewed on Jan 17, 2024

This course was a fantastic, comprehensive overview of data management for clinical research. The opportunities built in for practice and application of the principles were quite helpful.

Reviewed on May 15, 2019

A great course for someone who needs to learn about the people, process, and technology used in clinical research. It helped me to transfer my expertise from one industry to another.

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