Clinical Research: Mastering Good Clinical Practices (GCP)

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• Articulate the definition, purpose, and historical context of GCP.
• Explain the importance of GCP in protecting human subjects and ensuring data integrity.
• Identify key international organizations involved in establishing GCP standards.
• Apply ethical principles and informed consent procedures in clinical research.
• Understand the ICH E6(R2) guidelines on Integrated Addendum to Good Clinical Practice.
• Design and conduct clinical trials according to ICH E8 and E9 guidelines.
• Manage and report clinical trial data in compliance with ICH E6(R2) guidelines.
• Implement safety monitoring and adverse event reporting procedures as per ICH E6(R2) and E6(R3) guidelines.

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