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Back to the forum  Query: 2018-02-24 01:02 CET (UTC+1h)

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

posted by ElMaestro - Denmark, 2017-10-13 20:29  - Posting: # 17895
Views: 982

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:

I could be wrong, but…

Best regards,

- Bootstrapping for dissolution data is a relatively new hobby of mine.

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