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

posted by ElMaestro  – Denmark, 2023-02-16 07:55 (867 d 12:49 ago) – Posting: # 23468
Views: 4,156

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
23,425 posts in 4,928 threads, 1,684 registered users;
31 visitors (0 registered, 31 guests [including 10 identified bots]).
Forum time: 21:44 CEST (Europe/Vienna)

No problem can stand the assault of sustained thinking.    Voltaire

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