le courriel de recevabilité
| 15:51 Sep 5, 2020 |
| French to English translations [Non-PRO] Medical - Medical (general) / Application for a grant from the ANSM for an authorisation to modify a trial of a drug | |||||||
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| Summary of answers provided | ||||
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| 4 +1 | Letter of eligibility |
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| 4 | letter of eligibility or inclusion |
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| 4 | Approval Letter / / [Notification of Decision on Admissibility] |
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| Discussion entries: 3 | |
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Answers
1 hr confidence: 
peer agreement (net): +1
peer agreement (net): +1Letter of eligibility Explanation: Or alternatively, “eligibility letter” |
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1 hr confidence:
letter of eligibility or inclusion Explanation: See references please and loads of Ghits Reference: http://www.ecranproject.eu/en/content/who-can-participate-cl... https://www.fda.gov/media/134754/download |
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3 hrs confidence:
Approval Letter / / [Notification of Decision on Admissibility] Explanation: 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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