About this Course

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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.

Learner Career Outcomes

35%

started a new career after completing these courses

30%

got a tangible career benefit from this course

18%

got a pay increase or promotion

Shareable Certificate

Earn a Certificate upon completion

100% online

Start instantly and learn at your own schedule.

Flexible deadlines

Reset deadlines in accordance to your schedule.

Beginner Level

Approx. 17 hours to complete

English

Subtitles: Arabic, French, Portuguese (European), Chinese (Simplified), Italian, Vietnamese, Korean, German, Russian, Turkish, English, Spanish

Skills you will gain

Survey DesignData CollectionData ManagementClinical Data Management

Learner Career Outcomes

35%

started a new career after completing these courses

30%

got a tangible career benefit from this course

18%

got a pay increase or promotion

Shareable Certificate

Earn a Certificate upon completion

100% online

Start instantly and learn at your own schedule.

Flexible deadlines

Reset deadlines in accordance to your schedule.

Beginner Level

Approx. 17 hours to complete

English

Subtitles: Arabic, French, Portuguese (European), Chinese (Simplified), Italian, Vietnamese, Korean, German, Russian, Turkish, English, Spanish

Instructors

Instructor rating

4.6/5 (147 Ratings)

Stephany Duda, PhD

Associate Professor

Department of Biomedical Informatics

58,626 Learners

1 Course

Paul Harris, PhD

Professor

Biomedical Informatics and Biomedical Engineering

58,626 Learners

1 Course

Syllabus - What you will learn from this course

Content Rating93%(5,971 ratings)

Week

1

Week 1

3 hours to complete

Research Data Collection Strategy

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.

3 hours to complete

6 videos (Total 69 min), 1 reading, 2 quizzes

6 videos

How the Course Works7m

Course Introduction5m

Defining the Space10m

Research Data Planning 113m

Research Data Planning 224m

Approaches to Data Collection8m

1 reading

Course Logistics10m

1 practice exercise

Quiz 130m

Week

2

Week 2

3 hours to complete

Electronic Data Capture Fundamentals

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

3 hours to complete

9 videos (Total 130 min)

9 videos

Standardization of Study Processes14m

Validated Instruments13m

Data Standards: What Can Standards Do for You?15m

Data Standards: Basic Concepts and Overview15m

IRB, HIPAA, and FISMA14m

GCP and 21 CFR Part 1111m

Introduction to Electronic Data Capture (EDC)17m

EDC Concepts: Data Exports, Logging, User Rights, Project Creation12m

EDC Concepts: Data Imports, Scheduling, Reports, Internationalization14m

1 practice exercise

Quiz 230m

Week

3

Week 3

2 hours to complete

Planning a Data Strategy for a Prospective Study

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

2 hours to complete

9 videos (Total 92 min)

9 videos

Overview of the Study10m

Study Procedures10m

Baseline Data and Demographics13m

Visit Data5m

Review of Variables and Forms9m

Logging in to REDCap2m

Walkthrough: Creating a Project and Adding the First Variables16m

Walkthrough: Adding Fields to the Baseline Form12m

Walkthrough: Adding File Fields and Formatting10m

1 practice exercise

Quiz 330m

Week

4

Week 4

3 hours to complete

Practicing What We've Learned: Implementation

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.

3 hours to complete

9 videos (Total 101 min)

9 videos

Walkthrough: Creating Visit Forms8m

Walkthrough: Copying Variables, Renaming Forms9m

Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights17m

Walkthrough: Testing the REDCap Project7m

Example Study Wrap-Up3m

Mid Study Activities 112m

Mid Study Activities 215m

Data Quality11m

Data Quality Monitoring15m

1 practice exercise

Quiz 430m

Frequently Asked Questions

When will I have access to the lectures and assignments?
Access to lectures and assignments depends on your type of enrollment. If you take a course in audit mode, you will be able to see most course materials for free. To access graded assignments and to earn a Certificate, you will need to purchase the Certificate experience, during or after your audit. If you don't see the audit option:
The course may not offer an audit option. You can try a Free Trial instead, or apply for Financial Aid.
The course may offer 'Full Course, No Certificate' instead. This option lets you see all course materials, submit required assessments, and get a final grade. This also means that you will not be able to purchase a Certificate experience.
What will I get if I purchase the Certificate?
When you purchase a Certificate you get access to all course materials, including graded assignments. Upon completing the course, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. If you only want to read and view the course content, you can audit the course for free.
Is financial aid available?
Yes, Coursera provides financial aid to learners who cannot afford the fee. Apply for it by clicking on the Financial Aid link beneath the "Enroll" button on the left. You’ll be prompted to complete an application and will be notified if you are approved. Learn more.

More questions? Visit the Learner Help Center.

Data Management for Clinical Research