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Good Documentation Practices (GDP) in Clinical Research

Categories: Good Practices
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About Course

This course offers a deep dive into Good Documentation Practices (GDP) essential for clinical research and pharmaceutical industries. Participants will learn how to maintain clear, accurate, and traceable documentation following ALCOA+ principles. The course emphasizes compliance, audit-readiness, and real-world documentation scenarios—empowering learners to avoid regulatory pitfalls and maintain data integrity at every stage of a clinical trial.

What Will You Learn?

  • Understand the international ICH-GCP guidelines
  • Learn how to apply ethical principles in clinical research
  • Ensure compliance with subject safety and data integrity
  • Prepare for audits and inspections

Course Content

Introduction to GCP

  • What is Good Clinical Practice?
  • Historical Background of GCP
  • Scope and Application

GCP Principles

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