Pivotal and pilot BE Study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2017-07-07 14:05 (2773 d 04:09 ago) – Posting: # 17518
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Hi K Vishal,

there could be a ton of reasons.

But the one thing I'd check first and above all in exactly this situation is if the right randomization code was applied in the pilot (i.e. was the (single) generated code used for dispensing? Was the code used for stats?

Go onsite to check it yourself. Don't ask the CRO to send you the documentation.

Pass or fail!
ElMaestro

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