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

posted by ElMaestro  – Denmark, 2023-02-16 07:55 (461 d 10:54 ago) – Posting: # 23468
Views: 1,864

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!

Complete thread:

UA Flag
 Admin contact
23,035 posts in 4,835 threads, 1,643 registered users;
24 visitors (0 registered, 24 guests [including 6 identified bots]).
Forum time: 19:49 CEST (Europe/Vienna)

Satisfaction of one’s curiosity is one of the greatest sources
of happiness in life.    Linus Pauling

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