Statistical Analysis Plan Approval

[blackhuski]

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 "The statistical analysis plan (see Glossary) may be written as a separate document to be completed after finalising the protocol." but also on the other hand "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

[a123456]

I don't see a problem. 5.1 of E9 requires The statistical analysis plan ... to be completed after finalising the protocol.... and should be finalised before breaking the blind. So between those two dates. I'm sure that inspectors would like to see the drafts created and would look for sound rationales for any dramatic changes in the SAP. The SAP will always be reviewed to see if it is; fit-for-purpose , unbiased, fair, scientifically appropriate and statistically sound.