deviation reporting standards – Clinical Research Made Simple

ICH-GCP Expectations for Deviation Categorization

August 17, 2025

ICH-GCP Expectations for Deviation Categorization What ICH-GCP Guidelines Say About Categorizing Clinical Trial Deviations Overview of ICH-GCP Deviation Principles The International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines serve as the global foundation for conducting clinical trials ethically and scientifically. While ICH-GCP does not provide a rigid definition of “major” and “minor” protocol deviations,…

Major vs Minor Deviations, Protocol Deviation and CAPA Management

Regulatory Perspectives on Deviation Severity

August 16, 2025

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Regulatory Perspectives on Deviation Severity How Regulatory Authorities View and Evaluate Protocol Deviation Severity Why Regulatory Classification of Deviations Matters Protocol deviations are a routine part of clinical trial conduct. However, how these deviations are classified—as major or minor—has critical implications under the scrutiny of regulatory bodies such as the FDA, EMA, MHRA, and others….

Major vs Minor Deviations, Protocol Deviation and CAPA Management