Bekanntwerden
English translation: Incident reporting
| 19:33 Aug 17, 2017 |
| German to English translations [PRO] Medical - Medical (general) / Surgical outcomes | |||||||
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|  Selected response from: Michael Martin, MA United States Local time: 21:42 | ||||||
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| Summary of answers provided | ||||
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| 3 | Incident reporting |
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| 3 | (public) notice |
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| 3 | disclosure of adverse event reports ( as the heading) |
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| Discussion entries: 8 | |
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Answers
1 hr confidence: 
Incident reporting Explanation: Incidents become known when they're reported. Boy, that was insightful..:) |
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45 mins confidence:
(public) notice Explanation: Ein Angestellter der Organisation hat Informationen erworben, die die Vermutung zulassen, dass ein meldepflichtiges unerwünschtes Ereignis stattgefunden hat. An FDA employee has received information that does not rule out (the possibility) that a reportable adverse event has occurred. -------------------------------------------------- Note added at 48 mins (2017-08-17 20:22:09 GMT) -------------------------------------------------- a linguee ref so alwazs has to be taken with a pinch of salt but ok IMO Auf diese Weise kann ein öffentliches Bekanntwerden des Konflikts unterbunden werden und damit zugleich ein möglicher Imageschaden [...] pfk.at Consequently public notice of the conflict together with possible damage for the image of the involved person or company can be prevented. -------------------------------------------------- Note added at 51 mins (2017-08-17 20:24:26 GMT) -------------------------------------------------- "unerwünschtes Ereignis" is "adverse event" in FDA-speak -------------------------------------------------- Note added at 52 mins (2017-08-17 20:25:56 GMT) -------------------------------------------------- and not only FDA: https://de.wikipedia.org/.../Schwerwiegendes_unerwünschtes_E... Traducir esta página Ein schwerwiegendes unerwünschtes Ereignis (SUE) (von englisch serious adverse event, SAE) ist ein schwerwiegender Vorfall, der im Rahmen einer ... Rechtliche Vorgaben · Bekannte ... [PDF]Meldung von Serious Adverse Events (SAE ... - CAO/ARO/AIO-04 www.rektumkarzinom.med.uni-erlangen.de/.../Vortrag_SAE.pdf Begrifflichkeiten 3. Schwerwiegendes Unerwünschtes Ereignis /. Serious Adverse Event / SAE nach GCP-V § 3 (8):. Schwerwiegendes unerwünschtes Ereignis ... -------------------------------------------------- Note added at 55 mins (2017-08-17 20:28:25 GMT) -------------------------------------------------- https://www.accessdata.fda.gov/scripts/cdrh/.../CFRSearch.cf... (a) Definitions. The following definitions of terms apply to this section: Adverse drug experience. Any adverse event associated with the use of a drug in humans, ... -------------------------------------------------- Note added at 1 hr (2017-08-17 20:33:46 GMT) -------------------------------------------------- and back to "die die Vermutung zulassen" could be rendered as "allow the presumption" ... lots of wazs to do this bit, so up to you -------------------------------------------------- Note added at 1 hr (2017-08-17 20:34:43 GMT) -------------------------------------------------- with Phil and Kim on this too, we'll get there :) -------------------------------------------------- Note added at 1 hr (2017-08-17 20:37:23 GMT) -------------------------------------------------- sorry about the zzzs, was on German keyboard -------------------------------------------------- Note added at 1 hr (2017-08-17 20:59:46 GMT) -------------------------------------------------- if "Bekanntwerden" is a heading, ok but we would really need the full context -------------------------------------------------- Note added at 1 hr (2017-08-17 21:09:54 GMT) -------------------------------------------------- maybe "announcement" but hard to say |
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Notes to answerer
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4 days confidence:
disclosure of adverse event reports ( as the heading) Explanation: see the Transparency Report 2010-05-19 pdf, page 18, #3. "...if preliminary event information from adverse event reports is disclosed..." -------------------------------------------------- Note added at 5 days (2017-08-22 20:58:13 GMT) -------------------------------------------------- My apologies, I hadn't seen the discussion before I posted this. Herbalchemist had already pointed out the link and wording. The downside of checking this stuff on the mobile app is that you don't see everything. At least I don't, or I'm just not so savvy. Example sentence(s):
Reference: http://https://google2.fda.gov/search?q=Public+notice+of+pos... |
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Notes to answerer
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