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

[Guest guest]

Hello,

I'd say " competent authority " as in the EU Directive on clinical trials.

Best regards,

e

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helengenevier a écrit :

>

> 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)

>

>

[Guest guest]

You have registers for clinical trials (cancer registers, etc) and I think

the " organisme d'enrég " is the register.

Dorothy

2008/1/15, helengenevier :

>

> 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)

>

>

>

--

bien cordialement

Dorothée White

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