Informed consent [GxP / QC / QA]

posted by ElMaestro  – Denmark, 2015-07-20 14:07 (3637 d 02:50 ago) – Posting: # 15108
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Hi Krish,

❝ If suppose any of the essential elements of informed consent is missed during preparation and was identified after the study execution, what action shall be taken, I request you all to let me know the applicable steps to be taken as per GCP.


For one subject or for all subjects in a trial?
—
Pass or fail!
ElMaestro

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