When the the infusion speed deviate from the protocol specified [Study As­sess­ment]

posted by ElMaestro  – Belgium?, 2018-02-07 13:20  – Posting: # 18370
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Hi ssussu,

this is a very simple problem, and yet with no clear answer.
I find it highly interesting.

I think Helmut has some very valid good points still. Infusion stopping implies a perturbation on your data.
I would like to add one thought:
ICH E6, §2.13 "Systems with procedures that assure the quality of every aspect of the trial should be implemented (...and added recently...) Aspects of the trial that are essential to ensure human subject protection and reliability of trial results should be the focus of such systems."
My interpretation is that the Investigator (or her/his delegate) should be able to tell if this perturbation affects reliability / renders any data extracted from the subject unusable. If it does, then the ethical action is to discontinue the subject (e.g. §2.3, look also at protocol deviations). A soft scenario is to keep the subject but only using the data for tolerability, so if there was a PK, PD or efficacy component then exclude the subject from the dataset. At any rate (no pun intended), whether to include the subject or not requires sound healthy judgement and a signature so that it is clear someone actually has deliberated the issue and taken a decision - ideally then and there.

I could be wrong, but...
Best regards,
ElMaestro

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