Bioequivalence and Bioavailability Forum

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.