Data Management for Clinical Research

Data Management for Clinical Research

Instructors: Stephany Duda, PhD

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

Details to know

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Assessments

6 assignments

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 minutesPreview module
Course Introduction5 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 60 minutes

Assignment 1 - Survey Question Critique60 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 129 minutes

Standardization of Study Processes14 minutesPreview module
Validated Instruments13 minutes
Data Standards: What Can Standards Do for You?15 minutes
Data Standards: Basic Concepts and Overview15 minutes
IRB, HIPAA, and FISMA14 minutes
GCP and 21 CFR Part 1111 minutes
Introduction to Electronic Data Capture (EDC)17 minutes
EDC Concepts: Data Exports, Logging, User Rights, Project Creation12 minutes
EDC Concepts: Data Imports, Scheduling, Reports, Internationalization14 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 90 minutes

Overview of the Study10 minutesPreview module
Study Procedures10 minutes
Baseline Data and Demographics13 minutes
Visit Data5 minutes
Review of Variables and Forms9 minutes
Logging in to REDCap2 minutes
Walkthrough: Creating a Project and Adding the First Variables15 minutes
Walkthrough: Adding Fields to the Baseline Form13 minutes
Walkthrough: Adding File Fields and Formatting9 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 minutesPreview module
Walkthrough: Copying Variables, Renaming Forms8 minutes
Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights17 minutes
Walkthrough: Testing the REDCap Project7 minutes
Example Study Wrap-Up3 minutes
Mid Study Activities 112 minutes
Mid Study Activities 215 minutes
Data Quality11 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 148 minutes

Wrapping Up Your Study8 minutesPreview module
Sharing Your Work13 minutes
De-identifying Data8 minutes
De-identifying Dates12 minutes
Common Information Systems Used in Health Care13 minutes
Neuroimaging Data Management15 minutes
mHealth in Developing Countries19 minutes
Data Management for Multi-Center or Network Studies10 minutes
Resource-Limited Settings and Global Health13 minutes
Challenges of Collecting Data in Resource-Constrained Settings13 minutes
Data Privacy in Global Research11 minutes
International Data Sharing7 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 minutesPreview module
Survey Design13 minutes
Survey Procedures and Implementation12 minutes
Survey Testing, Administration, and Analysis10 minutes
Survey Overview and REDCap Setup12 minutes
Survey Testing and Distribution10 minutes
Thank you for participating!0 minutes

1 assignmentTotal 30 minutes

Week 6 Quiz30 minutes

1 peer reviewTotal 60 minutes

Assignment 3 - Build, Deploy, and Report on a Survey60 minutes

1 discussion promptTotal 10 minutes

Share Assignment 3 survey links (optional)10 minutes

Instructors

Instructor ratings

4.7 (527 ratings)

Stephany Duda, PhD

Vanderbilt University

1 Course125,001 learners

Paul Harris, PhD

Vanderbilt University

1 Course125,001 learners

Offered by

Vanderbilt University

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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

Reviewed on Jul 30, 2023

I could not find a better course than this. The most interesting course in my career. I listened to every word of it. Special thanks to Mr. Paul Harris and his team for this masterpiece. Thank you.

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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