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

posted by ElMaestro  – Denmark, 2019-11-15 22:51 (1115 d 16:06 ago) – Posting: # 20810
Views: 2,193

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

Complete thread:

UA Flag
Activity
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
25 visitors (0 registered, 25 guests [including 9 identified bots]).
Forum time: 14:57 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5