EU, method C preference [Two-Stage / GS Designs]

posted by ElMaestro  – Belgium?, 2019-10-11 10:25 (416 d 17:48 ago) – Posting: # 20683
Views: 2,688

Hi all,

I remember having heard EU regulators mention preference for method C out of consideration for the type I error. But I can't seem to find a presentation from anyone saying so. Do you know, do one of you experts have a link or a presentation by a regulator where this was stated?

Many thanks.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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