Feb 1, 2021 11:03
3 yrs ago
21 viewers *
Italian term

presa in carico dei validatori

Italian to English Medical Medical: Pharmaceuticals clinical trial
Ai fini della validazione della documentazione in oggetto in accordo alla normativa vigente (DM 21/12/2007 e successive modifiche, DM 27/04/2015, comunicati AIFA del 24/06/2015, 30/06/2015, 15/07/2015, 06/08/2015, 29/01/2016, 11/05/2016, 21/12/2016, 24/04/2017 e 01/08/2019 pubblicati sul Portale AIFA), si fa presente che lo studio è stato caricato in OsSC come sola Fase II, cosa che ha creato disguidi nella presa in carico dei validatori all’interno dell’Ufficio, mentre nella lettera di trasmissione si dichiara che trattasi di una Fase Ib/II.

Discussion

JudyC Feb 2, 2021:
possible interpretation The discrepancy in trial classification between what was entered in the OsSC online system (Phase II trial) and what was stated in the accompanying letter (PhaseIb/II) ("lettera di trasmissione", normally paper-based or only since Covid to be uploaded as an attachment in OsSC or sent by certified email) caused delays in processing the application by the validators of the Ufficio [Sperimentazioni Cliniche], the AIFA office that receives and processes clinical trial applications.

My only problem with this interpretation is the preposition "dei" before "validatori", as it would have worked better with "da parte dei validatori".


Proposed translations

9 mins

taking over the validators' accounts

.
Peer comment(s):

neutral philgoddard : No, it's the validators who are taking over, and it doesn't say anything about accounts.
2 hrs
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+1
3 hrs

when the study was referred to the validators

Or was received by, or anything along those lines. I assume the "ufficio" is the OsSC, Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali.
Peer comment(s):

agree pennylyd : yes, something along those lines
5 hrs
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