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Data Validation and Quality Control in CDM

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About Course

Focus on ensuring data integrity and validation. This course teaches practical approaches to data quality, edit checks, audit trails, discrepancy resolution, and QC reports for regulatory submission.

What Will You Learn?

  • Role of CDM in clinical research
  • CRF (Case Report Form) design basics
  • Data validation workflows
  • ICH-GCP and regulatory compliance
  • Introduction to EDC systems (e.g., REDCap, Oracle Clinical)

Course Content

Introduction to CDM
What is Clinical Data Management? Role of CDM in Clinical Trials Key Terminology (CRF, EDC, DCF, GCP)

Clinical Trial Phases and Regulatory Overview

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