This course is designed to teach important concepts related to research data planning, collection, storage and dissemination. Instructors will offer information and best-practice guidelines for 1) investigator-initiated & sponsored research studies, 2) single- & multi-center studies, and 3) prospective data collection & secondary-reuse of clinical data for purposes of research. The curriculum will balance theoretical guidelines with the use of practical tools designed to assist in planning and conducting research. Real-world research examples, problem solving exercises and hands-on training will ensure students are comfortable with all concepts.
Data Management for Clinical Research will balance best-practice guidelines and hands-on demonstrations & exercises in covering important concepts related to research data collection and management. We will focus primarily on data management for patient-centered (clinical) research, but core data management principles are applicable across all research domains. Clinical research is an essential part of all medical advances and directly impacts our societal ability to prevent, detect and treat medical conditions as well improve the quality of life for individuals with need for medical devices.
The course is organized as follows:Week 1
Course Introduction, Mechanics and Broad Coverage (what topics are in/out with respect to data management principles covered by the course)
Planning a Data Collection StrategyWeek 2
Standardizing Operations and Procedures
Electronic Data Capture SystemsWeek 3
Practicing What We Have Learned - Working Through Planning, EDC Setup and Study LaunchWeek 4
Data Management Considerations Once a Study Is Launched (Mid-Study Operations and Challenges)
Data Management Considerations Once a Study Is Finished
Special Topic: Regulatory Requirements and ComplianceWeek 5
Special Topic: Collecting Information Directly From Research Participants (Surveys)
Special Topic: Imaging Data
Special Topic: Multi-Center and Network Studies
Special Topic: Resource-Limited Settings and Global Health Studies
Special Topic: Using Data Standards
A general interest in medical research (any scientific domain) and basic computer skills.
The class will consist of lecture videos, which are between 10 and 20 minutes in length with integrated quiz questions. There will also be standalone quizzes and assignments that are not part of video lectures.