Study population in biostudies in the EU: mixed or not? [Regulatives / Guidelines]
Dear marcel,
As far as I have been told this is a slight anomaly related to some rules that have little to do with GCP or regulatory science. If I got it right it is an equal opportunity issue. I was told CRO's in Jordan cannot in a straightforward and legal manner go out and invite only male participants for a study on a drug taken by both genders. Something like that.
“A customer can have a car painted any color he wants as long as it’s black” [H. Ford.]
No, not Harrison.
❝ My question is: do you know if there has been any regulatory change on that field which could explain such a question?
As far as I have been told this is a slight anomaly related to some rules that have little to do with GCP or regulatory science. If I got it right it is an equal opportunity issue. I was told CRO's in Jordan cannot in a straightforward and legal manner go out and invite only male participants for a study on a drug taken by both genders. Something like that.
“A customer can have a car painted any color he wants as long as it’s black” [H. Ford.]
No, not Harrison.

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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Study population in biostudies in the EU: mixed or not? Marcel-Duclos Efoudebe 2017-09-14 16:31 [Regulatives / Guidelines]
- ♂ ¬ ♀ Helmut 2017-09-15 15:26
- Study population in biostudies in the EU: mixed or not?ElMaestro 2017-09-15 18:46