Bioequivalence and Bioavailability Forum

Hi,

thanks for telling this story.
I would consider it a potentially serious issue. Did the PI or delegates note anything about protocol deviations or AEs necessitating parenteral fluids?
If no, then I'd say here a big issue (big as in major or critical).
I would collect immediately (copies of):

1. The delegation logs
   
2. Source docs for AEs and PDs, and any forms documenting the administration of the fluids and the reason for doing so.
   
3. CRFs

And I would note down for posterity in writing, if written docs (in the form of PDs or AEs) do not exist just in case you worry about post-hoc back-dating of documentation.

I am not so worried about the BE proof itself, but about the ethics, just like Hötzi points out. The sponsor is in a serious regulatory/ethical and possible legal limbo if a subject has, say, a case of fever and septicemia after the parenteral administration (this will likely end up as a discussion where the trial insurer and the doctor's / clinic's insurer are pointing at each other, and the subjects will accordingly suffer).