ICH E6
In Good Clinical Practice & ethics
Also known as: E6 guideline, ICH GCP
ICH E6 is the specific ICH guideline that sets out Good Clinical Practice. It describes the duties of sponsors, investigators, and ethics committees, what a protocol must contain, and which essential documents a trial must keep. When people say "GCP", they usually mean ICH E6.
Why it matters
E6 is the document your employer's SOPs are written against. Knowing where a requirement comes from makes it much easier to explain a decision to a monitor or an inspector.
Related terms
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Get your free roadmap →Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.