Data Management for Clinical Research

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.

• 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.
• Electronic Data Capture Fundamentals
• This module covers standards for study processes, concepts for regulatory compliance, and electronic data capture fundamentals.
• Planning a Data Strategy for a Prospective Study
• This module reviews the process of planning data elements for a real-world research study.
• 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.
• 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!
• 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.