Protocol Deviation

Protocol Deviation
Отклонение от протокола
Отклонение от протокола по-разному определяется на различных компаниях и противопоставляется его нарушению.
В общем и целом, под отклонением от протокола понимается происшедшее в ходе исследования событие, вступающие в противоречие с требованиями протокола и для которого не предусмотрено специальной поправки, однако менее серьёзное, чем нарушение.
Основная разница между отклонением от протокола и его нарушением заключается в том, что пациенты-нарушители протокола не могут быть включены в анализ эффективности, в то время как пациенты, у которых имеются отклонения от протокола, включаются в этот анализ.

English-Russian dictionary of terms used in the conduct of clinical trials on medicinal products. 2013.

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