Bioequivalence and Bioavailability Forum 05:12 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Enrollment when exclusion criteria are met [GxP / QC / QA]

posted by ElMaestro - Denmark, 2017-10-13 20:29  - Posting: # 17895
Views: 1,474

Hi all,

I have a question about a recent warning letter posted here.

Long story short: a subject had a long QTc interval which should imply exclusion and the investigator included the subject anyway.
Then FDA write: "(...) you should have received permission from the sponsor before enrolling the subject."

Can someone explain this principle in slow motion to me?

I am not aware ever of exclusion criteria being dismissable by Sponsor's decree. I am not aware of anyone other than the PI or her/his delegated colleagues who can take decisions about enrolling or not in cases of doubt about fitness for the trial so I would be surprised if the protocol makes provisions for such a thing.
Please educate me here. Do you think FDA meant the investigator should have conferred with the PI (and not the sponsor) or what on Earth am I overlooking?

Many thanks for educating me.:ok:

if (3) 4

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:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,698 posts in 3,983 threads, 1,237 registered users;
online 5 (0 registered, 5 guests [including 4 identified bots]).

When puzzled, it never hurts to read the primary documents –
a rather simple and self-evident principle that has, nonetheless,
completely disappeared from large sectors
of the American experience.    Stephen Jay Gould

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