Создание архива исследователя

English translation: archiving of investigator's documentation

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16:01 Jun 10, 2018
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals
Russian term or phrase: Создание архива исследователя
«Правила проведения клинических испытаний лекарственных средств в соответствии с требованиями GCP»
Вопросы, рассмотренные на семинаре:
История развития и основные положения правил надлежащей клинической практики (GCP).
Разработка новых лекарственных средств, основные принципы проведения клинических испытаний.
Этические вопросы проведения клинических испытаний.
Контроль за проведением клинических испытаний.
Файл исследователя.
Основные понятия.
Категории и функции документов клинического испытания.
Создание архива исследователя.
Требования к мониторингу безопасности в ходе клинических испытаний.
Anastasia Serdyukova
Russian Federation
Local time: 09:15
English translation:archiving of investigator's documentation
Explanation:
Например:

Archiving
www.gcphelpdesk.com/faqs/37-archiving
Common practice is for sponsors to archive the investigator documents on behalf of the ...
Selected response from:

Natalie
Poland
Local time: 08:15
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1archiving of investigator's documentation
Natalie
4archive construction of the clinical trial investigator
Vladys


  

Answers


2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
archive construction of the clinical trial investigator


Explanation:
Certain aspects of archive construction and operation may be affected by local or ... Investigator Site: Institution or facility where the clinical trial, or part of a trial is ... https://the-hsraa.org/wp-content/uploads/2017/12/GCPArchiveG...



    https://en.wikipedia.org/wiki/Clinical_investigator
Vladys
Ukraine
Local time: 09:15
Works in field
Native speaker of: Native in RussianRussian
PRO pts in category: 78
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4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
archiving of investigator's documentation


Explanation:
Например:

Archiving
www.gcphelpdesk.com/faqs/37-archiving
Common practice is for sponsors to archive the investigator documents on behalf of the ...

Natalie
Poland
Local time: 08:15
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 504

Peer comments on this answer (and responses from the answerer)
agree  Andrey Svitanko
1 day 3 hrs
  -> Спасибо!
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