Bioequivalence and Bioavailability Forum • TEAE

TEAE [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2014-03-12 18:17 (4493 d 18:46 ago) – Posting: # 12610
Views: 4,245

Hi Hötzi,

❝ You have to report all AEs, expected or not, drug-related or not. Once in our studies a volunteer was bitten by a dog in the washout period. Since he had to visit the next ambulance to get some stitches, it was even an SAE. Drug-related? No way. Reported? Sure.

What if a volunteer eats a psychotropic drug and then bites a dog? Who can hold who legally responsible if the investigator considers this occurrence of aggression drug related? - What if the drug was T? What if it was R? Who must pay the vet's fee when the dog needs stitches?

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Pass or fail!
ElMaestro

Complete thread:

Drowsiness Rajdoc 2014-03-11 12:08
- TEAE Helmut 2014-03-11 13:40
  - TEAE Rajdoc 2014-03-12 07:06
    - TEAE Ohlbe 2014-03-12 14:17
    - TEAE Helmut 2014-03-12 16:53
      - TEAEElMaestro 2014-03-12 17:17
        
        OT Helmut 2014-03-12 17:38
  - AE definition in BEQ study mittyri 2014-03-13 20:40
    - Great post! Helmut 2014-03-14 14:39