CDM: Clinical Data Management Certification Course

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CDM: Clinical Data Management Certification Course

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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.

What Will You Learn?

  • 1. Understanding of Clinical Data Management (CDM) processes in clinical trials.
  • 2. Knowledge of regulatory compliance (GxP, FDA, ICH).
  • 3. Skills in data collection, validation, and cleaning techniques.
  • 4. Familiarity with Electronic Data Capture (EDC) systems.
  • 5. Proficiency in handling clinical trial data and reporting.
  • 6. Insight into clinical trial phases and data monitoring.
  • 7. Ability to manage data security and privacy (GDPR, HIPAA).
  • 8. Understanding of data analysis and statistical tools used in CDM.

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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