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adverse events with prespecified monitoring documentation and reporting

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14:29 Dec 5, 2010
This question was closed without grading. Reason: No acceptable answer

English to Russian translations [PRO]
Medical - Medical (general) / Clinical trials
English term or phrase: adverse events with prespecified monitoring documentation and reporting
Добрый вечер!
Кто-нибудь знает, как это перевести?
Буду благодарен за любую помощь.
These monitoring visits will include but not be limited to review of the following aspects:
patient’s informed consent, patient recruitment and follow-up, serious adverse event documentation and reporting, adverse events with prespecified monitoring documentation and reporting, adverse event documentation, investigational product allocation, patient compliance with the investigational products regimen, investigational products accountability, concomitant therapy use, and quality of data.
Alieksei Seniukovich
Belarus
Local time: 02:01
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Summary of answers provided
3 +3нежелательные явления, для которых специально предусмотрена регистрация в документации и отчетность
Maksym Nevzorov
4нежелательные явления с особыми требованиями по мониторингу
Eric Candle
2 -1документация и отчетность по серьезным противопоказаниям
erika rubinstein


  

Answers


5 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): -1
документация и отчетность по серьезным противопоказаниям


Explanation:
...

erika rubinstein
Local time: 00:01
Native speaker of: Native in RussianRussian, Native in GermanGerman
PRO pts in category: 159

Peer comments on this answer (and responses from the answerer)
disagree  Natalie: Здесь не говорится о противопоказаниях
3 hrs
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23 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
нежелательные явления, для которых специально предусмотрена регистрация в документации и отчетность


Explanation:
Возможны небольшие коррекции исходя из общего контекста - поищите по тексту, есть ли где еще упоминания "prespecified" в этом отношении.

Maksym Nevzorov
Ukraine
Local time: 01:01
Specializes in field
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 1053

Peer comments on this answer (and responses from the answerer)
agree  Pavel Nikonorkin
2 hrs

agree  Igor_2006
10 hrs

agree  Natalie
20 hrs
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4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
нежелательные явления с особыми требованиями по мониторингу


Explanation:
Monitoring covers documentation and reporting,
http://cra-club.ru/index2.php?option=com_docman&task=doc_vie...

Eric Candle
Local time: 18:01
Works in field
Native speaker of: Russian
PRO pts in category: 24
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