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

posted by ElMaestro  – Denmark, 2023-02-16 07:55 (874 d 21:43 ago) – Posting: # 23468
Views: 4,182

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!
ElMaestro

Complete thread:

UA Flag
Activity
 Admin contact
23,428 posts in 4,929 threads, 1,687 registered users;
55 visitors (0 registered, 55 guests [including 17 identified bots]).
Forum time: 06:39 CEST (Europe/Vienna)

To know that we know what we know,
and to know that we do not know what we do not know,
that is true knowledge.    Nicolaus Copernicus

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5