Statistical Analysis Plan Approval
Dear Experts,
Can you give me hint by when a SAP needs to be finalized and approved during the conduct of a clinical Trial?
Or the other way round, is it possible to have a SAP in a draft stage, prior to unblind the data?
5.1 of E9 talks about "[FONT=TimesNewRoman][SIZE=3][FONT=TimesNewRoman][SIZE=3]The statistical analysis plan (see Glossary) may be written as a separate document to be completed after finalising the protocol.[/SIZE][/FONT][/SIZE][/FONT]" but also on the other hand [FONT=TimesNewRoman][SIZE=3][FONT=TimesNewRoman][SIZE=3]"The plan should be reviewed and possibly updated as a result of the blind review of the data (see 7.1 for definition) and should be finalised before breaking the blind."
There could be a huge time differnce by when a protocol is finalized and the time when the blind will be broken.
What is the Industry standard there?
Thanks a million,
Andreas[/SIZE][/FONT][/SIZE][/FONT]