Re: FR > EN vérificateur de l’organisme d’enregistrement

[Guest guest]

Thank you to Dorothy, e and . As there was not 100%

agreement and as consent forms should not be ambiguous, I've put a

note to the client on that one and will post if I get an answer.

Cheers,

Helen

>

> Hello everyone,

> This is from the French version of a consent form for use in a

Belgian

> centre. I am not sure whether the " enrégistrement " is " recording "

of

> data (so the data management centre/clinical research organisation)

> or " registration " as in licensing and referring to the agency in

charge

> of marketing authorisation for medical devices. I'm used to France

and

> UK and wonder if these are US or Belgian terms.

>

> " À l'exception de votre médecin, du personnel de la société [uS-

based

> medical devices manufacturer], de son représentant, du vérificateur

de

> l'organisme d'enregistrement et du comité d'éthique, aucune

personne

> n'aura accès à ces informations.

>

> Any enlightenment would be appreciated,

> Helen (Genevier)

>