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 P4: Make trials scientifically sound, supported by adequate nonclinical and clinical data and current knowledge, and review new scientific information periodically for needed modifications

What does P4 require?

Trials should be scientifically valid for their purpose and rest on adequate, current knowledge: the nonclinical and clinical data available on the product should support the trial, the design should reflect what is known about the product, the condition, the underlying biology and the intended population, and current science should be reviewed periodically because new information during the trial may call for changes.

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

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