09:06 Oct 21, 2014 |
English to Dutch translations [PRO] Medical - Medical: Pharmaceuticals / toelating | |||||||
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| Selected response from: Catharina Adams Belgium Local time: 05:20 | ||||||
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Summary of answers provided | ||||
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4 | registeronderzoeken |
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3 | postmarketingonderzoek |
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Discussion entries: 5 | |
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registeronderzoeken Explanation: Er wordt onderzoek gedaan met behulp van gegevens uit een register Reference: http://www.ntvg.nl/artikelen/pati%C3%ABnt-cross-overstudies |
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postmarketingonderzoek Explanation: Dit lijkt te gaan om postmarketingonderzoeken: - “real world data” - our new product - with real world insights into the general treatment of ... Het gaat dan om het verzamelen van gegevens gedurende een van te voren vastgelegde tijd over het 'gedrag' van het geregistreerde, goedgekeurde product in the 'real world' in plaats van onder de gecontroleerde omstandigheden van een klinisch onderzoek. Er wordt daarbij dan primair nagegaan hoe het zit met de veiligheid en effectiviteit van het product in de 'real world' (i.p.v. wat gebleken is in klinische onderzoeken). Also see: Registry: a 'registry' is a list or dataset of records about something, a 'patient registry' is a dataset of records about patients. Registry study: usually an observational study on a post-approval device, also known as a post-market study. FDA has no role or reason to set forth guidance documents, expect in the rare cases when they have legislative authority under Section 522, because the studies are conducted on 510(k) cleared or IDE approved devices. The registry can be as small or large as your pocketbook will allow, it can be single-armed or comparative depending on how you contrast your technology the standard of practice, it can be monitored or not monitored depending on how much you care about the quality of the data you collect. http://clinicaldevice.typepad.com/cdg_whitepapers/registry-s... |
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