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

posted by ElMaestro  – Denmark, 2018-02-07 13:20  – Posting: # 18370
Views: 5,473

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.

if (3) 4

x=c("Foo", "Bar")
b=data.frame(x)
typeof(b[,1]) ##aha, integer?
b[,1]+1 ##then let me add 1


Best regards,
ElMaestro

“(...) targeted cancer therapies will benefit fewer than 2 percent of the cancer patients they’re aimed at. That reality is often lost on consumers, who are being fed a steady diet of winning anecdotes about miracle cures.” New York Times (ed.), June 9, 2018.

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,437 posts in 4,125 threads, 1,325 registered users;
online 8 (1 registered, 7 guests [including 7 identified bots]).
Forum time (Europe/Vienna): 01:54 CEST

On two occasions I have been asked,—“Pray, Mr. Babbage,
if you put into the machine wrong figures,…
will the right answers come out?”

I am not able rightly to apprehend the kind of confusion of ideas
that could provoke such a question.    Charles Babbage

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5