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,