open-label BE trials maintain blindness [Study Per­for­mance]

posted by kimhuang – China, 2023-10-18 02:50 (130 d 14:33 ago) – Posting: # 23762
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❝ So there are no SOP w.r.t. pre-dose concentration, abnormal PK concentration, λz estimation? Generally QA goes ahead with protocol inclusion/exclusion criteria and SOP of BA.

there's no SOP about handing these cases, case-by-case discuss in blinded data review meeting.

❝ Does BA team also have access to CRF? Then how it is blinded?

BA is blinded.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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