Sep 5, 2020 15:51
3 yrs ago
36 viewers *
French term

le courriel de recevabilité

Non-PRO French to English Medical Medical (general) Application for a grant from the ANSM for an authorisation to modify a trial of a drug
Comme on vous a expliqué dans le courriel de recevabilité, je vous informe que notre décision est différée.
Votes to reclassify question as PRO/non-PRO:

PRO (1): Cyril Tollari

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Discussion

SafeTex Sep 5, 2020:
@ Thomas and all Yes, that makes sense. I didn't like "email of eligibility or inclusion" and I did also wonder if it was indeed a letter attached to the email but "notification" is a possibility.
Thomas Miles Sep 5, 2020:
Notification of ... Suggested generalisation as this is not a printed letter.
Suzie Withers Sep 5, 2020:
Isn't this about an application to make an amendment to a clinical trial? And in this case, the body has deferred their decision as to whether the amendment is acceptable? I don't think it's about the eligibility of participants in the trial? I don't know what the term is, though. Something like the "Acceptance decision letter".

Proposed translations

+1
1 hr

Letter of eligibility

Or alternatively, “eligibility letter”
Peer comment(s):

agree philgoddard : The latter :-)
4 hrs
thanks Phil
Something went wrong...
1 hr

letter of eligibility or inclusion

See references please and loads of Ghits
Something went wrong...
3 hrs

Approval Letter / / [Notification of Decision on Admissibility]

These are two separate possiblities depending on whether or not the trial has been approved by the Ethics Review Board.

Option 1
MODÈLE DE LETTRE DE RECEVABILITÉ DE L’ALLÉGATION DES FONDS DE
RECHERCHE DU QUÉBEC

https://uqo.ca/sites/default/files/fichiers/9051-politique-c...

Recevabilité = admissibility, elegibility

This would be a [Decision on] Elegibility/Admissibility Letter.

If the trial has yet to be approved and has not yet obtained a "Certificate of Approval" it must undergo an Initial Review. In this case it would be a "Decesion on Admissibility for Initial Review".

"Before this they must submit a Decision on Admissibility
If a submission is deemed to be an appropriate candidate, the Project Lead will be established. They will request a formal letter from the applicant seeking a joint review.

Based on the information gathered through the pre-submission discussions and the formal request from the applicant, the partner regulators will consider a variety of factors before deciding to proceed with a joint review. The partner regulators will communicate the decision on admissibility to the applicant via formal letter from the Project Lead."
https://www.canada.ca/en/health-canada/services/drugs-health...

However, with the Asker's context it sounds as though in this case it is not an application for funds, but a request for the board to "approve" the change to their study and include it in their "Certificate of Approval", which is regularly reviewed and the board will give their approval or not.

To submit a proposal to modify a drug trial is to propose an amendment to the Ethics Review Board which requires their "approval".

This is communicated with a "Formal Approval Letter"

https://www.uwo.ca/research/ethics/human/Resources/Post-Appr...
http://www.rqhealth.ca/service-lines/master/files/9008576_8_...
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