Electronic Data Capture
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Table of Contents
Table of Contents
This course provides educational information and does not replace professional medical advice, diagnosis, treatment, or clinical judgment.
Transform clinical research data management from paper-based inefficiency to streamlined electronic collection, ensuring accuracy and speed.
What You Will Learn
- 1 Learn the fundamentals and evolution of Electronic Data Capture in clinical research.
- 2 Understand the architecture and core components of modern EDC systems.
- 3 Explore data standards and interoperability principles for seamless data exchange.
- 4 Discover the process of designing and building EDC studies including form creation and edit checks.
- 5 Apply data quality and validation techniques to ensure clean clinical data.
- 6 Recognize regulatory compliance requirements including 21 CFR Part 11 and Good Clinical Practice.
- 7 Develop implementation strategies and user training programs for EDC systems.
- 8 Analyze data management and monitoring workflows within EDC platforms.
- 9 Evaluate integration capabilities with external systems like ePRO, eCOA, and CTMS.
- 10 Identify future trends and advanced topics such as risk-based monitoring and artificial intelligence.
What's Included
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Electronic Data Capture