About The Course
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
The course is organized as follows:
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 Strategy
Standardizing Operations and Procedures
Electronic Data Capture Systems
Practicing What We Have Learned - Working Through Planning, EDC Setup and Study Launch
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 Compliance
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
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.
A general interest in medical research (any scientific domain) and basic computer skills.
- What resources will I need for this class?
For this course, you will need: 1) an Internet connection; 2) software package capable of generating table-based CSV files (e.g. Microsoft Excel, Google Docs, Numbers);
- Why should I take this class?
Data drives medical research and medical research drives scientific findings that ultimately result in improving human health. This course will enable you to be play an integral part in the process.