Draft Principles of ICH E6 Good Clinical Practice (GCP) now Available

On 19 April 2021 the ICH announced the availability of the draft principles of ICH E6 GCP.

The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. This guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality is needed for each clinical trial.

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