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RegisterAre Statistical Analysis Plans “required” for Pivotal Studies? [General Statistics]
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.
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
Pass or fail!
ElMaestro
Complete thread:
- Are Statistical Analysis Plans “required” for Pivotal Studies? Sereng 2023-02-08 18:23 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- SAP vs. part of the clinical protocol Helmut 2023-02-09 09:49
- SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
- Traceability Helmut 2023-02-11 13:22
- SAP vs. part of the clinical protocol Sereng 2023-02-10 23:34
- Are Statistical Analysis Plans “required” for Pivotal Studies? Achievwin 2023-02-15 12:07
- Are Statistical Analysis Plans “required” for Pivotal Studies?ElMaestro 2023-02-16 06:55
- SAP vs. part of the clinical protocol Helmut 2023-02-09 09:49
Ing. Helmut Schütz