Clinical Data Management
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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.
Clinical data management transforms raw trial data into reliable evidence, ensuring that regulatory submissions withstand scrutiny and that patient outcomes are accurately measured.
What You Will Learn
- 1 Understand the fundamentals of clinical data management and its role in clinical research.
- 2 Explore the regulatory landscape governing clinical data including ICH-GCP, FDA, and HIPAA.
- 3 Learn the process of clinical trial data collection and case report form design.
- 4 Understand data entry, validation, and quality assurance procedures.
- 5 Apply concepts of database design and management for clinical data.
- 6 Analyze data coding and standardization using MedDRA, WHO Drug, and CDISC.
- 7 Implement data query management and discrepancy resolution.
- 8 Develop skills in clinical data reporting and statistical analysis preparation.
- 9 Evaluate the role of technology and emerging trends in clinical data management.
- 10 Synthesize knowledge into a comprehensive data management plan.
What's Included
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Clinical Data Management