GCP inspection by Roszdravnadzor

State institutions determine the rules for conducting clinical trials of drugs; therefore, they must directly monitor their conduct. The main form of control over clinical trials of drugs by the state is the inspection. This is article describes the types of inspections, the main identified violatio...

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Bibliographic Details
Main Authors: E. S. Rogov (Author), D. Yu. Belousov (Author), S. K. Zyryanov (Author), A. S. Kolbin (Author), L. I. Karpenko (Author)
Format: Book
Published: Izdatelstvo OKI, 2018-06-01T00:00:00Z.
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700 1 0 |a S. K. Zyryanov  |e author 
700 1 0 |a A. S. Kolbin  |e author 
700 1 0 |a L. I. Karpenko  |e author 
245 0 0 |a GCP inspection by Roszdravnadzor 
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520 |a State institutions determine the rules for conducting clinical trials of drugs; therefore, they must directly monitor their conduct. The main form of control over clinical trials of drugs by the state is the inspection. This is article describes the types of inspections, the main identified violations, proposed further actions and consequences. 
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690 |a инспекция клинического исследования 
690 |a клинические исследования 
690 |a росздравнадзор 
690 |a надлежащая клиническая практика 
690 |a Medical technology 
690 |a R855-855.5 
690 |a Pharmacy and materia medica 
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655 7 |a article  |2 local 
786 0 |n Качественная клиническая практика, Vol 0, Iss 1, Pp 66-76 (2018) 
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787 0 |n https://doaj.org/toc/2618-8473 
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