Стандарты

Опубликовано Ksenia-Polo - пт, 10/22/2021 - 16:52

ICH E9 https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials

https://zdrav.expert/index.php/%D0%9A%D0%BE%D0%BC%D0%BF%D0%B0%D0%BD%D0%B8%D1%8F:Clinical_Data_Interchange_Standards_Consortium_(CDISC)

http://lib.uniyar.ac.ru/edocs/iuni/20190302.pdf#:~:text=%D0%A1%D1%82%D0%B0%D0%BD%D0%B4%D0%B0%D1%80%D1%82%20GCP%20(%C2%ABGood%20Clinical%20Practice%C2%BB%2C,%D0%B2%20%D0%BA%D0%B0%D1%87%D0%B5%D1%81%D1%82%D0%B2%D0%B5%20%D0%B8%D1%81%D0%BF%D1%8B%D1%82%D1%83%D0%B5%D0%BC%D0%BE%D0%B3%D0%BE%20(%D0%BA%D0%BB%D0%B8%D0%BD%D0%B8%D1%87%D0%B5%D1%81%D0%BA%D0%B8%D0%B5%20%D0%B8%D1%81%D1%81%D0%BB%D0%B5%D0%B4%D0%BE%D0%B2%D0%B0%D0%BD%D0%B8%D1%8F)

 

http://astgmu.ru/wp-content/uploads/2020/04/08.05.2020_10_Pravila-GLP-GCP-I-GMP.pdf

 

https://rusregister.ru/standards/good-practice-gxp/