Impact of Parenteral hydration in a BE study [Study As­sess­ment]

posted by ElMaestro  – Denmark, 2019-11-15 21:51 (615 d 18:17 ago) – Posting: # 20810
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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).

Pass or fail!
ElMaestro

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