Adverse event [Regulatives / Guidelines]

posted by ElMaestro  – Denmark, 2013-10-30 14:27 (4620 d 07:52 ago) – Posting: # 11815
Views: 3,261

Hi Rameswari jena,

❝ So can you plz give the exact reason that the AE is related to the drug.


I absolutely can't. The staff, incl. notably PI and MD's, know the drug, they screened and interviewed the volunteers, they know and documented all the circumstances. Only they are the ones who can and must provide the argumentation.

Pass or fail!
ElMaestro

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