IRB reserves [Design Issues]

posted by ElMaestro  – Denmark, 2018-01-16 23:16 (2379 d 16:43 ago) – Posting: # 18187
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Hi Relaxation,

❝ As far as I know (better "remember", my training on the protocol template was admittedly not recent), there is only one relevant reason for drug screening: to have a test for subjects with an increased risk of non-compliance to study conditions. It's not fair to assume that all drug users are unreliable (and for me a little bit inadequate), but it is a point.


It goes beyond that.
WHO is defining substance abuse and alcoholism as disease in its own right. Many if not most countries assign a psychiatric diagnosis to people with substance abuse.
If you are positive for the drug screen/alcohol test you are potentially not healthy (as in a healthy adult volunteer, which coincidentially fits the description of the typical BE subject quite well). A regulator who hasn't slept well would also throw the term "vulnerable" at you - check the definition in ICH E6, along with the regard to "well-being".
Checking for these things really isn't something you do for the sake of the trial or for the sponsor or for the CRO's smooth operation - it is first and foremost something you do in the interest of the subject.

Pass or fail!
ElMaestro

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