дополнительные документы по проведению клинического испытания
English translation: supporting/supplemental documentation on/relating to clinical trial [conduct]
| 16:04 Dec 3, 2016 |
| Russian to English translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Evgeni Kushch Ukraine Local time: 12:52 | ||||||
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| 4 | additional documents for the conduct of a clinical trial |
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| 3 | supporting/supplemental documentation on/relating to clinical trial [conduct] |
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Answers
14 mins confidence: 
supporting/supplemental documentation on/relating to clinical trial [conduct] Explanation: Я обычно встречаю в этот контексте supporting documentation. Но думаю еще можно supplemental documentation. Перевод для проведения я думаю можно смело опустить. -------------------------------------------------- Note added at 21 mins (2016-12-03 16:25:31 GMT) -------------------------------------------------- Обычно supporting, правда, это перевод для "сопроводительной документации", но если я не ошибаюсь, здесь он тоже вполне применим к "дополнительным документам" |
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1 day 1 hr confidence:
additional documents for the conduct of a clinical trial Explanation: Even when using the TMF reference model, the specific details of a trial might result in the need for additional documents to allow conduct or reconstruction of the trial. The best place to determine this is when conducting the trial’s risk assessment before the trial begins. http://www.wingspan.com/how-do-you-determine-essential-docum... -------------------------------------------------- Note added at 1 day3 hrs (2016-12-04 19:22:16 GMT) -------------------------------------------------- В документе "НАЦИОНАЛЬНЫЙ СТАНДАРТ РОССИЙСКОЙ ФЕДЕРАЦИИ НАДЛЕЖАЩАЯ КЛИНИЧЕСКАЯ ПРАКТИКА GOOD CLINICAL PRACTICE (GCP)" понятия "дополнительные документы" нет, есть "основные документы", и сгруппированы они в три раздела в зависимости от стадии клинического исследования. В NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE(CPMP/ICH/135/95), следовательно, аналога этому понятию тоже нет. Поэтому я предложила вольный перевод термина. |
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