Glossary entry (derived from question below)
French term or phrase:
attributaire
English translation:
beneficiary, recipient
Added to glossary by
joanna menda
Mar 5, 2022 16:15
2 yrs ago
35 viewers *
French term
attributaire
French to English
Medical
Medical (general)
Incident report
Hi,
I am translating an ANSM form reporting an incident or risk of incident of a medical device.
At the top of the page there is a box "Cadre réservé à l'ANSM" and in this box there is:
Numéro
Attributaire
Sous-commission
Date d'attribution
All these categories are blank. Would "attributaire" in this case be "assignee" or "recipient"?
This is for the USA
Thanks
Joanna
I am translating an ANSM form reporting an incident or risk of incident of a medical device.
At the top of the page there is a box "Cadre réservé à l'ANSM" and in this box there is:
Numéro
Attributaire
Sous-commission
Date d'attribution
All these categories are blank. Would "attributaire" in this case be "assignee" or "recipient"?
This is for the USA
Thanks
Joanna
Proposed translations
(English)
3 +1 | beneficiary, recipient | Nikki Scott-Despaigne |
3 | supplier/contractor | Barbara Cochran, MFA |
3 | allocated by | Daryo |
References
CPP attributaire | ph-b (X) |
Proposed translations
+1
2 days 5 hrs
Selected
beneficiary, recipient
I see this the other way round to the previous two posters, thus rather as the entity to whom something has been attributed not the entity that is attributing something.
Having the full Cerfa reference is essential context here. ;-) It enables one to check the legal source which you can see here: https://www.legifrance.gouv.fr/codes/section_lc/LEGITEXT0000...
Scan for "attrib..." and you'll get three hits. From how I understand this, the meaning of "attributaire" is to describe the entity receiving not the one handing out. Thus "beneficiary" or "recipient".
This might be further supported by the ordinary dictionary definiton of the term according to Larousse: https://www.larousse.fr/dictionnaires/francais/attributaire/... : "attributaire
1. Personne à qui a été attribué un lot, une gratification, un héritage, etc.
Synonyme : bénéficiaire"
Having the full Cerfa reference is essential context here. ;-) It enables one to check the legal source which you can see here: https://www.legifrance.gouv.fr/codes/section_lc/LEGITEXT0000...
Scan for "attrib..." and you'll get three hits. From how I understand this, the meaning of "attributaire" is to describe the entity receiving not the one handing out. Thus "beneficiary" or "recipient".
This might be further supported by the ordinary dictionary definiton of the term according to Larousse: https://www.larousse.fr/dictionnaires/francais/attributaire/... : "attributaire
1. Personne à qui a été attribué un lot, une gratification, un héritage, etc.
Synonyme : bénéficiaire"
Peer comment(s):
neutral |
Daryo
: makes no sense - the ANSM is the "recipient" of this report and also the one filing this box, so just putting their own name???// WHO could "the beneficiary" of an "incident report" regarding a medical device??? Doesn't fit to context.
3 days 5 hrs
|
agree |
ph-b (X)
: Not for me to discuss a native speaker's choice of words, but aire definitely points to a "receiving party" (cf. destinataire vs. expéditeur). Sorry, I thought I'd sent this message eons ago.
6 days
|
4 KudoZ points awarded for this answer.
Comment: "Thanks Nikki!"
51 mins
supplier/contractor
The entity that supplied the device, is the way I interpret it.
https://dictionary.reverso.net/french-english/attributaire
https://dictionary.reverso.net/french-english/attributaire
Peer comment(s):
neutral |
Daryo
: that meaning would be fine in the context of a tender, but this ST is not about any tender.// once you have the blank form, you can see it can't be that as there is another box for that info
12 hrs
|
1 day 6 hrs
allocated by
At which stage this box will be filled gives a clue about the intended meaning.
In this form there are 3 main parts to fill by whoever submits the report:
- info about who is submitting the incident report
- info about the medical device (including the info about the supplier/manufacturer)
- info about the incident itself
the box "Cadre réservé à l'ANSM" is for internal use by ANSM, so it would contain ***ONLY information added by ANSM*** about how the submitted incident report is being processed within this organisation.
IOW that box would include information purely internal to ANSM such as to who this case (report) was allocated for examination / processing, when, by who to who and similar info.
So
"Numéro" would be an internal reference number given to this incident report (for sure)
"Attributaire" would the one deciding to who to allocate this case - "l'attribution de tâches" (that would make most sense ***in this form***)
"Sous-commission" would be one of many sub-committee of the ANSM to which this incident report was allocated to for analysis/examination (can't see what else would make sense)
"Date d'attribution" would be the date when this incident report was allocated for to this specific committee (for sure)
To make things "simpler", in the relevant REGULATION (EU) 2017/745 of 5 April 2017 on medical devices, etc "l'attribution" is used in several different meanings, of which "l'attribution de tâches" would be most relevant as far as this indicent report form is concerned.
the whole form
https://ansm.sante.fr/uploads/2020/10/09/20201009-cerfa-1024...
the form being part of the procedure for testing medical devices:
https://ansm.sante.fr/uploads/2021/05/21/2021-05-21-tableau-...
--------------------------------------------------
Note added at 1 day 6 hrs (2022-03-06 23:13:28 GMT)
--------------------------------------------------
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CEL...
https://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CEL...
https://dicom-portail-sante-preprod.cegedim.cloud/IMG/pdf/ta...
--------------------------------------------------
Note added at 5 days (2022-03-11 03:11:36 GMT)
--------------------------------------------------
"attributaire" is used in several different meanings in the relevant legislation.
"CPP attributaires" are only mentioned in the stage of approving the trial of some medical device, can't see anywhere that these CCP are in charge of examining "incident reports" - that's the competence of L' Agence nationale de sécurité du médicament et des produits de santé (ANSM)
I can hardly imagine the ANSM passing "incident reports" to any "Comité de Protection des Personnes (CPP)" whose role, as far the available information shows, is limited to giving their approval BEFORE testing of medical devices can begin, and nothing else.
Les Comités de Protection des Personnes (CPP) sont chargés d’émettre un avis préalable sur les conditions de validité de toute recherche impliquant la personne humaine, au regard des critères définis par l’article L 1123-7 du Code de la Santé Publique (CSP).
WHERE does it say that these CCP have anything to do with "incident reports"?
--------------------------------------------------
Note added at 5 days (2022-03-11 03:25:25 GMT)
--------------------------------------------------
You have to take into account the context:
1 - at which point in the life cycle of a medical device this form gets to be used: after incidents happening with medical devices already approved for use (IOW none of the CPP's business)
2- which part of the form it is - the one for internal use by the recipient of the form - the "Sous-commission" to which the case is "attributed" is one internal to the AMSM (bureaucracy 101: they (AMSM) are not going to decide for another body which "Sous-commission" of that other body will take the case)
In this form there are 3 main parts to fill by whoever submits the report:
- info about who is submitting the incident report
- info about the medical device (including the info about the supplier/manufacturer)
- info about the incident itself
the box "Cadre réservé à l'ANSM" is for internal use by ANSM, so it would contain ***ONLY information added by ANSM*** about how the submitted incident report is being processed within this organisation.
IOW that box would include information purely internal to ANSM such as to who this case (report) was allocated for examination / processing, when, by who to who and similar info.
So
"Numéro" would be an internal reference number given to this incident report (for sure)
"Attributaire" would the one deciding to who to allocate this case - "l'attribution de tâches" (that would make most sense ***in this form***)
"Sous-commission" would be one of many sub-committee of the ANSM to which this incident report was allocated to for analysis/examination (can't see what else would make sense)
"Date d'attribution" would be the date when this incident report was allocated for to this specific committee (for sure)
To make things "simpler", in the relevant REGULATION (EU) 2017/745 of 5 April 2017 on medical devices, etc "l'attribution" is used in several different meanings, of which "l'attribution de tâches" would be most relevant as far as this indicent report form is concerned.
the whole form
https://ansm.sante.fr/uploads/2020/10/09/20201009-cerfa-1024...
the form being part of the procedure for testing medical devices:
https://ansm.sante.fr/uploads/2021/05/21/2021-05-21-tableau-...
--------------------------------------------------
Note added at 1 day 6 hrs (2022-03-06 23:13:28 GMT)
--------------------------------------------------
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CEL...
https://eur-lex.europa.eu/legal-content/FR/TXT/HTML/?uri=CEL...
https://dicom-portail-sante-preprod.cegedim.cloud/IMG/pdf/ta...
--------------------------------------------------
Note added at 5 days (2022-03-11 03:11:36 GMT)
--------------------------------------------------
"attributaire" is used in several different meanings in the relevant legislation.
"CPP attributaires" are only mentioned in the stage of approving the trial of some medical device, can't see anywhere that these CCP are in charge of examining "incident reports" - that's the competence of L' Agence nationale de sécurité du médicament et des produits de santé (ANSM)
I can hardly imagine the ANSM passing "incident reports" to any "Comité de Protection des Personnes (CPP)" whose role, as far the available information shows, is limited to giving their approval BEFORE testing of medical devices can begin, and nothing else.
Les Comités de Protection des Personnes (CPP) sont chargés d’émettre un avis préalable sur les conditions de validité de toute recherche impliquant la personne humaine, au regard des critères définis par l’article L 1123-7 du Code de la Santé Publique (CSP).
WHERE does it say that these CCP have anything to do with "incident reports"?
--------------------------------------------------
Note added at 5 days (2022-03-11 03:25:25 GMT)
--------------------------------------------------
You have to take into account the context:
1 - at which point in the life cycle of a medical device this form gets to be used: after incidents happening with medical devices already approved for use (IOW none of the CPP's business)
2- which part of the form it is - the one for internal use by the recipient of the form - the "Sous-commission" to which the case is "attributed" is one internal to the AMSM (bureaucracy 101: they (AMSM) are not going to decide for another body which "Sous-commission" of that other body will take the case)
Reference comments
1 day 21 hrs
Reference:
CPP attributaire
3) La recherche
Les principaux acteurs de la recherche publique fondamentale sont, pour leur part, les laboratoires des centres hospitaliers universitaires et les grands organismes publics de recherche comme le CNRS, l'Inserm, l'INRETS, l'INRA ou l'ANRS. Les projets de recherche initiés par ces structures doivent recueillir l'autorisation de l'ANSM et, dans les cas où ils intégreraient des interventions sur la personne humaine, l'avis favorable d'un comité de protection des personnes (CPP).
http://www.senat.fr/rap/l20-172/l20-1726.html
Les Comités de Protection des Personnes (CPP) sont chargés d’émettre un avis préalable sur les conditions de validité de toute recherche impliquant la personne humaine, au regard des critères définis par l’article L 1123-7 du Code de la Santé Publique (CSP).
https://www.iledefrance.ars.sante.fr/comites-de-protection-d...
More information here: https://solidarites-sante.gouv.fr/IMG/pdf/guide-faq_deposant... esp. Pour ces projets de recherche, dans l’attente du système d’information européen Eudamed, il
convient, lorsque le dossier a été soumis sur le SIRIPH2G, de le soumettre ensuite le même jour à l’ANSM en lui précisant le nom du CPP tiré au sort pour ce projet.
I understand that these CPP attributaires are public "committees" (?) tasked by French health authorities with assessing if the piece of research they've been assigned (attribuée) can be conducted safely on human beings.
Good luck with the actual translation!
--------------------------------------------------
Note added at 1 jour 21 heures (2022-03-07 13:50:11 GMT)
--------------------------------------------------
Just in case my penultimate sentence is not clear - doesn't sound like good English to me! - these CPP don't actually carry out the research. However, they check, presumably on the basis of the docs they are shown, that that research is safe for human beings if using them is part of the procedure.
Les principaux acteurs de la recherche publique fondamentale sont, pour leur part, les laboratoires des centres hospitaliers universitaires et les grands organismes publics de recherche comme le CNRS, l'Inserm, l'INRETS, l'INRA ou l'ANRS. Les projets de recherche initiés par ces structures doivent recueillir l'autorisation de l'ANSM et, dans les cas où ils intégreraient des interventions sur la personne humaine, l'avis favorable d'un comité de protection des personnes (CPP).
http://www.senat.fr/rap/l20-172/l20-1726.html
Les Comités de Protection des Personnes (CPP) sont chargés d’émettre un avis préalable sur les conditions de validité de toute recherche impliquant la personne humaine, au regard des critères définis par l’article L 1123-7 du Code de la Santé Publique (CSP).
https://www.iledefrance.ars.sante.fr/comites-de-protection-d...
More information here: https://solidarites-sante.gouv.fr/IMG/pdf/guide-faq_deposant... esp. Pour ces projets de recherche, dans l’attente du système d’information européen Eudamed, il
convient, lorsque le dossier a été soumis sur le SIRIPH2G, de le soumettre ensuite le même jour à l’ANSM en lui précisant le nom du CPP tiré au sort pour ce projet.
I understand that these CPP attributaires are public "committees" (?) tasked by French health authorities with assessing if the piece of research they've been assigned (attribuée) can be conducted safely on human beings.
Good luck with the actual translation!
--------------------------------------------------
Note added at 1 jour 21 heures (2022-03-07 13:50:11 GMT)
--------------------------------------------------
Just in case my penultimate sentence is not clear - doesn't sound like good English to me! - these CPP don't actually carry out the research. However, they check, presumably on the basis of the docs they are shown, that that research is safe for human beings if using them is part of the procedure.
Note from asker:
Thanks ph-b! That's very helpful! |
Peer comments on this reference comment:
agree |
Nikki Scott-Despaigne
: Yes, the receiver not the giver.
7 hrs
|
neutral |
Daryo
: wrong stage of the whole procedure - these CCP are involved in a preliminary step in approving trials NO MENTION ANYWHERE of these CCP being involved in what happens after trials like these "indicent reports"
3 days 13 hrs
|
Discussion
Scan for "attrib..." and you'll get three hits. From how I understand this, the meaning of "attributaire" is to describe the entity receiving not the one handing out. Thus "beneficiary" or "recipient".
THis might be further supported by the ordinary dictionary definiton of the term according to Larousse: https://www.larousse.fr/dictionnaires/francais/attributaire/... : "attributaire
nom
1. Personne à qui a été attribué un lot, une gratification, un héritage, etc.
Synonyme :
bénéficiaire"
At the top of the page there is a box "Cadre réservé à l'ANSM" and in this box there is:
Numéro
Attributaire
Sous-commission
Date d'attribution
are we talking of this form?
https://ansm.sante.fr/uploads/2020/10/09/20201009-cerfa-1024...
Seems to fit the bill.
Knowing for sure that it's about THAT form would cut out a lot of avoidable guessing .. and wandering in all sort of directions except the right one.
Seems like it might refer to the date when the contract (see the translation I offered) was awarded.
"Début de
l’IC
Modalités
dépôt
Dépôt le même jour au CPP puis à l’ANSM, en
informant l’ANSM du CPP attributaire
Dépôt le même jour au CPP puis à
l’ANSM, en informant l’ANSM du CPP
attributaire
Dépôt le même jour au CPP puis à l’ANSM, en informant
l’ANSM du CPP attributaire "
(Last section on page 2.)
https://ansm.sante.fr/uploads/2021/05/21/2021-05-21-tableau-...