Enrollment when exclusion criteria are met [GxP / QC / QA]
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.
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"(...) 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.