00:54 May 28, 2020 |
Spanish to English translations [PRO] Medical - Medical (general) / Health Research Register Form | |||||
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| Selected response from: Michael Grabczan-Grabowski Canada Local time: 05:11 | ||||
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3 +2 | NOT FOR REGISTRATION PURPOSES |
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3 | without registration purposes |
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NOT FOR REGISTRATION PURPOSES Explanation: In the province of Córdoba, Argentina, there are certain kinds of clinical trials that need to be registered with the Registro Provincial de Investigaciones en Salud (RePIS), particularly if they deal with clinical pharmacological studies, where the purpose is to register a particular pharmacological intervention. In the link https://www.cba.gov.ar/wp-content/4p96humuzp/2012/07/DISPOSI... the following are deemed to be con fines registrales y/o reguladores: "a) Estudios de Fases I, II y III; b) Estudios de productos ya registrados en ANMAT que evalúen una nueva indicación, nueva concentración si es mayor a la ya registrada, nueva posología o nueva forma farmacéutica con propósito de registro; c) Todos los estudios de farmacocinética, biodisponibilidad y bioequivalencia." The US Food and Drug Administration works similarly; it's necessary to submit clinical studies of drugs for them to be considered for registration and listing. I would translate the whole line as follows: UNREGULATED RESEARCH REGISTRY – NOT FOR REGISTRATION PURPOSES |
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12 hrs confidence:
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