Data Management for Clinical Research

Vanderbilt University

Acerca de este Curso

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.

Curso 100 % en línea

Comienza de inmediato y aprende a tu propio ritmo.

Nivel principiante

Aprox. 25 horas para completar

Sugerido: 6 weeks of study, 2-4 hours per week

English

Subtítulos: English

Habilidades que obtendrás

Data ManagementData CollectionClinical Data ManagementSurvey Design

Curso 100 % en línea

Comienza de inmediato y aprende a tu propio ritmo.

Nivel principiante

Aprox. 25 horas para completar

Sugerido: 6 weeks of study, 2-4 hours per week

English

Subtítulos: English

Syllabus - What you will learn from this course

1

Section

4 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....

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 readings

Course Logistics10m

1 practice exercises

Quiz 116m

2

Section

3 hours to complete

Electronic Data Capture Fundamentals

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

9 videos (Total 130 min), 1 quiz

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 exercises

Quiz 220m

3

Section

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....

9 videos (Total 92 min), 1 quiz

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 exercises

Quiz 314m

4

Section

4 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....

9 videos (Total 101 min), 2 quizzes

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 exercises

Quiz 414m

5

Section

3 hours to complete

Post-Study Activities and Other Considerations

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!...

12 videos (Total 149 min), 1 quiz

12 videos

Wrapping Up Your Study8m

Sharing Your Work13m

De-identifying Data8m

De-identifying Dates12m

Common Information Systems Used in Health Care13m

Neuroimaging Data Management15m

mHealth in Developing Countries19m

Data Management for Multi-Center or Network Studies10m

Resource-Limited Settings and Global Health13m

Challenges of Collecting Data in Resource-Constrained Settings13m

Data Privacy in Global Research11m

International Data Sharing7m

1 practice exercises

Quiz 516m

6

Section

4 hours to complete

Data Collection with Surveys

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....

7 videos (Total 75 min), 2 quizzes

7 videos

Benefits, Scope, and Validated Instruments12m

Survey Design13m

Survey Procedures and Implementation12m

Survey Testing, Administration, and Analysis10m

Survey Overview and REDCap Setup12m

Survey Testing and Distribution12m

Thank you for participating!0m

1 practice exercises

Week 6 Quiz12m

Instructors

Stephany Duda, PhD

Associate Professor

Paul Harris, PhD

Professor

About Vanderbilt University

Vanderbilt University, located in Nashville, Tenn., is a private research university and medical center offering a full-range of undergraduate, graduate and professional degrees....

Frequently Asked Questions

When will I have access to the lectures and assignments?
Once you enroll for a Certificate, you’ll have access to all videos, quizzes, and programming assignments (if applicable). Peer review assignments can only be submitted and reviewed once your session has begun. If you choose to explore the course without purchasing, you may not be able to access certain assignments.
What will I get if I pay for this course?
If you pay for this course, you will have access to all of the features and content you need to earn a Course Certificate. If you complete the course successfully, your electronic Certificate will be added to your Accomplishments page - from there, you can print your Certificate or add it to your LinkedIn profile. Note that the Course Certificate does not represent official academic credit from the partner institution offering the course.
What is the refund policy?
Is financial aid available?
Yes! Coursera provides financial aid to learners who would like to complete a course but cannot afford the course fee. To apply for aid, select "Learn more and apply" in the Financial Aid section below the "Enroll" button. You'll be prompted to complete a simple application; no other paperwork is required.

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Data Management for Clinical Research