
About Course
This course provides a comprehensive overview of the Clinical Data Management process, focusing on data collection, validation, analysis, and regulatory compliance in clinical trials.
Course Content
Introduction to Clinical Data Management
Developing a Data management plan
Data Collection and Validation Techniques
Electronic Data Capture (EDC) Systems
Regulatory Compliance in Clinical Trials (GxP, FDA, ICH)
Safety data management
Data closure, archiving
Data Analysis and Reporting
Emerging trends
Cumulative Quiz
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