Are Statistical Analysis Plans “required” for Pivotal Studies? [General Sta­tis­tics]

posted by ElMaestro  – Denmark, 2023-02-16 07:55 (108 d 20:37 ago) – Posting: # 23468
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Hi Sereng,

to the best of my knowledge and experience, in practice no SAP is generally required but you are expected to have a description prior to reconciliation with the RC which describes everything you will do in sufficient detail that you do not have degrees of freedom after the point when the reconciliation is done.

It is not formulated this way in any guidance document.

Pass or fail!

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