Data Management for Clinical Research

Data Management for Clinical Research

Instructors: Stephany Duda, PhD

Access provided by Department of State OIG/INV

140,323 already enrolled

6 modules

Gain insight into a topic and learn the fundamentals.

1,864 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.

1,864 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

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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 videos Total 69 minutes

How the Course Works 7 minutes
Course Introduction 6 minutes
Defining the Space 10 minutes
Research Data Planning 1 13 minutes
Research Data Planning 2 24 minutes
Approaches to Data Collection 8 minutes

1 reading Total 10 minutes

Course Logistics 10 minutes

1 assignment Total 30 minutes

Quiz 1 30 minutes

1 peer review Total 120 minutes

Assignment 1 - Survey Question Critique 120 minutes

1 discussion prompt Total 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 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

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

What's included

9 videos1 assignment1 discussion prompt

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

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 videos Total 99 minutes

Walkthrough: Creating Visit Forms 8 minutes
Walkthrough: Copying Variables, Renaming Forms 8 minutes
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

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 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

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 videos Total 73 minutes

Benefits, Scope, and Validated Instruments 12 minutes
Survey Design 14 minutes
Survey Procedures and Implementation 12 minutes
Survey Testing, Administration, and Analysis 11 minutes
Survey Overview and REDCap Setup 12 minutes
Survey Testing and Distribution 11 minutes
Thank you for participating! 1 minute

1 assignment Total 30 minutes

Week 6 Quiz 30 minutes

1 peer review Total 60 minutes

Assignment 3 - Build, Deploy, and Report on a Survey 60 minutes

1 discussion prompt Total 10 minutes

Share Assignment 3 survey links (optional) 10 minutes

Instructors

Instructor ratings

(610 ratings)

Stephany Duda, PhD

Vanderbilt University

1 Course 140,323 learners

Paul Harris, PhD

Vanderbilt University

1 Course 140,323 learners

Offered by

Vanderbilt University

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Learner reviews

5 stars
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4 stars
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3 stars
1.66%
2 stars
0.64%
1 star
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Showing 3 of 1864

Reviewed on Jun 22, 2020

This course is very carefully designed to give a moderate idea how the eCRFs are made in RedCap database system.It gives you a fair background of clinical research processes and database designing.

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 Nov 9, 2024

Very detailed lecture with hands-on experience in one of the software for managing clinical research - REDCap

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