Randomization access [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2015-08-10 11:51 (3472 d 09:28 ago) – Posting: # 15208
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Hi bkrao,

❝ My question is whether the treatment randomization is accessable to the bioanalytical persons before the intioation of the bioanalytial phase.


Usually, BE studies are open-label and control of the rand. code is thus not extremely crucial, but it is a good habit in the industry to keep the rand. code away from bioanalysts. Most companies I know of state that bioanalysts are actually kept blind, both in protocols and SOPs. I think this is a very healthy principle but it is not specifically regulated by a guideline.

Pass or fail!
ElMaestro

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