"Removal" of an outlier: subject vs period [Outliers]

posted by ElMaestro  – Denmark, 2013-08-07 13:09 (3590 d 08:29 ago) – Posting: # 11230
Views: 9,763

Hi Mac,

❝ The question is, should this subject be removed completely from the study or just the period in question?

Where do you intend to submit?
What does your protocol say about outlier issues?
What do CRFs and raw data tell about the subject in question (or possibly: the subject in question compared to subjects you consider more normal or clustered around a mean of sorts)?

❝ (...) since we don't know what caused the "unusual" profile in the Test 2 profile, perhaps it's better to remove the subject altogether.

Or perhaps it is better not to remove any data at all in order to make sure that the true product performances are reflected in the CIs.

Pass or fail!

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