ICH E6(R3) - Good Clinical Practice
Introduction and the Principles of ICH GCP – ICH E6(R3) - Good Clinical Practice

ICH E6(R3) - Good Clinical Practice P8: Describe the trial in a clear, concise, scientifically sound and feasible protocol with explicit objectives and equally clear execution plans

What does P8 require?

A well-designed protocol underpins participant protection and reliable results; it should state scientific objectives clearly and explicitly, and the protocol and its execution documents (for example the statistical analysis, data management and monitoring plans) should be clear, short and workable in practice.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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