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.
Data Management for Clinical Research
Offered By
Data Management for Clinical Research
Vanderbilt University
About this Course
4.7
425 ratings
Skills you will gain
Survey DesignData CollectionData ManagementClinical Data Management
Syllabus - What you will learn from this course
Week
1Research 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
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 116m
Week
2Electronic 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
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 220m
Week
3Planning 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
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 314m
Week
4Practicing 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: 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 414m
4.7
39%
83%
20%
Top Reviews
By NS•Mar 1st 2017
I find the course helpful and a good introduction into data management. I'm hoping that there is a follow up course to take us further and deeper in planning for a study and data analysis.
By PM•Oct 11th 2017
I enjoyed the course very much and I learned a lot! I would definitely recommend it to someone that wants to get some background knowledge about clinical research and data management.
Instructors
Stephany Duda, PhD
Associate ProfessorDepartment of Biomedical Informatics
Paul Harris, PhD
ProfessorBiomedical Informatics and Biomedical Engineering
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 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.
What is the refund policy?
Is financial aid available?
More questions? Visit the Learner Help Center.
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