13:57 Aug 24, 2015 |
German to English translations [PRO] Medical - Medical: Health Care / BfArM letter | |||||||
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| Selected response from: Carola Lange United Kingdom | ||||||
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Summary of answers provided | ||||
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4 | Change index |
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1 +1 | amendment level |
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Discussion entries: 6 | |
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amendment level Explanation: Well, all we know here is that the S is "regarding a substantial amendment" " in a clinical trial context", so this would be my best guess. amendment level + clinical trial https://goo.gl/jmg4hq |
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Change index Explanation: Index, certainly rather than level in this context, what is asked is an overview of the changes Often also termed Revision index for documents, but in this case felt 'change' was more apt - see also relevant terminology in the link https://www.gov.uk/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues |
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