About 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.
Created by: Vanderbilt University
Taught by: Stephany Duda, PhD, Assistant Professor
Department of Biomedical Informatics
Taught by: Paul Harris, PhD, Professor
Biomedical Informatics and Biomedical Engineering
| Level | Beginner |
| Commitment | 6 weeks of study, 2-4 hours per week |
| Language | English |
| How To Pass | Pass all graded assignments to complete the course. |
| User Ratings |
Syllabus
WEEK 1
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, 1 reading
- Video: How the Course Works
- Video: Course Introduction
- Video: Defining the Space
- Reading: Course Logistics
- Discussion Prompt: What is your background in this area?
- Video: Research Data Planning 1
- Video: Research Data Planning 2
- Video: Approaches to Data Collection
Graded: Quiz 1
Graded: Assignment 1 - Survey Question Critique
WEEK 2
Electronic Data Capture Fundamentals
This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.
9 videos
- Video: Standardization of Study Processes
- Video: Validated Instruments
- Video: Data Standards: What Can Standards Do for You?
- Video: Data Standards: Basic Concepts and Overview
- Discussion Prompt: What standards have you used?
- Video: IRB, HIPAA, and FISMA
- Video: GCP and 21 CFR Part 11
- Video: Introduction to Electronic Data Capture (EDC)
- Video: EDC Concepts: Data Exports, Logging, User Rights, Project Creation
- Video: EDC Concepts: Data Imports, Scheduling, Reports, Internationalization
Graded: Quiz 2
WEEK 3
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
- Video: Overview of the Study
- Video: Study Procedures
- Video: Baseline Data and Demographics
- Video: Visit Data
- Video: Review of Variables and Forms
- Discussion Prompt: How have you assembled a study data management plan?
- Video: Logging in to REDCap
- Video: Walkthrough: Creating a Project and Adding the First Variables
- Video: Walkthrough: Adding Fields to the Baseline Form
- Video: Walkthrough: Adding File Fields and Formatting
Graded: Quiz 3
WEEK 4
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
- Video: Walkthrough: Creating Visit Forms
- Video: Walkthrough: Copying Variables, Renaming Forms
- Video: Walkthrough: Using the Shared Library, Longitudinal Events, Optional Modules, and User Rights
- Video: Walkthrough: Testing the REDCap Project
- Video: Example Study Wrap-Up
- Video: Mid Study Activities 1
- Video: Mid Study Activities 2
- Video: Data Quality
- Video: Data Quality Monitoring
- Discussion Prompt: What data quality challenges have you encountered?
Graded: Assignment 2 - First REDCap Assignment
Graded: Quiz 4
WEEK 5
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
- Video: Wrapping Up Your Study
- Video: Sharing Your Work
- Video: De-identifying Data
- Video: De-identifying Dates
- Video: Common Information Systems Used in Health Care
- Video: Neuroimaging Data Management
- Video: mHealth in Developing Countries
- Discussion Prompt: What health care information systems have you worked with?
- Video: Data Management for Multi-Center or Network Studies
- Video: Resource-Limited Settings and Global Health
- Video: Challenges of Collecting Data in Resource-Constrained Settings
- Video: Data Privacy in Global Research
- Video: International Data Sharing
Graded: Quiz 5
WEEK 6
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
- Video: Benefits, Scope, and Validated Instruments
- Video: Survey Design
- Video: Survey Procedures and Implementation
- Video: Survey Testing, Administration, and Analysis
- Video: Survey Overview and REDCap Setup
- Video: Survey Testing and Distribution
- Discussion Prompt: Share Assignment 3 survey links (optional)
- Video: Thank you for participating!
Graded: Week 6 Quiz
Graded: Assignment 3 - Build, Deploy, and Report on a Survey
FAQs
How It Works
Coursework
Each course is like an interactive textbook, featuring pre-recorded videos, quizzes and projects.
Help from Your Peers
Connect with thousands of other learners and debate ideas, discuss course material, and get help mastering concepts.
Certificates
Earn official recognition for your work, and share your success with friends, colleagues, and employers.
Creators
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.
Ratings and Reviews
Very interesting and useful course for people that are thinking a career in clinical research. I enjoyed the courses and I found the assessments challenging.
Excellent overview of Clinical data management and an introduction to basic concepts in the field.
I would recommend this to anyone who is new to clinical research! After completing this course, I feel more confident in my understanding of the logistics of clinical research and the intricacies of clinical data.
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