Missing samples [Study As­sess­ment]

posted by ElMaestro  – Belgium?, 2020-04-29 17:21 (213 d 02:09 ago) – Posting: # 21367
Views: 2,256

Hi Amira Gouda,

» he did not attend the samples collection for 24,48 and 72 hours intervals (as the study protocol stated that the hospitalization lasts only for 12 hours)

BE is generally done on the PP population, not on the ITT.
This guy is clearly not participating PP, his AUC is not outright a meaningful indicator of product performance, so out he goes, I think.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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