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Schmiggins

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Schmiggins

Re: None

Thursday, 09/21/2023 1:47:19 AM

Thursday, September 21, 2023 1:47:19 AM

Post# of 463809
Statistical Analysis Plan (SAP)...."The Statistical Analysis Plan (SAP) Sample Template for Clinical Trials is a technical document that describes in detail the planned statistical analysis of a clinical trial as outlined in the protocol."

Special Protocol Assessment: ...(SPA)
"An SPA agreement indicates concurrence by FDA on the acceptability of the overall protocol design to ensure that it will be considered adequate"

I never saw these two acronyms defined here, so ....
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