most updated AE reporting period language

Russian translation: новейшие формулировки по НЯ за отчетный период

18:14 Mar 8, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: most updated AE reporting period language
8.4.1 Adverse Event Reporting Period
After informed consent has been signed but prior to the administration of the study drug, only AEs and SAEs caused by the protocol-required intervention (eg, biopsy) should be reported.
Rationale for change
To be consistent with other protocols based on the most updated AE reporting period language.
Anastasia Serdyukova
Russian Federation
Local time: 01:41
Russian translation:новейшие формулировки по НЯ за отчетный период
Explanation:
*
Selected response from:

Natalie
Poland
Local time: 00:41
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4самые последние формулировки/определения для периода уведомления о НЯ
Margarita Vidkovskaia
4новейшие формулировки по НЯ за отчетный период
Natalie


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
most updated ae reporting period language
новейшие формулировки по НЯ за отчетный период


Explanation:
*

Natalie
Poland
Local time: 00:41
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 9043
Login to enter a peer comment (or grade)

12 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
most updated ae reporting period language
самые последние формулировки/определения для периода уведомления о НЯ


Explanation:
8.4.1 Период уведомления о нежелательных явлениях
После подписания информированного согласия и до начала применения исследуемого препарата следует уведомлять только о тех НЯ и СНЯ, которые обусловлены выполнением вмешательств согласно протоколу (например, биопсии).
Обоснование внесенных изменений: обеспечить соответствие другим протоколам, в которых используются самые последние формулировки/определения для периода уведомления о НЯ.

Margarita Vidkovskaia
Russian Federation
Local time: 01:41
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 757
Login to enter a peer comment (or grade)



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