Initiation of the Study

Initiation of the Study
Начало (исследования)
Процедура "открытия" исследовательского центра для набора пациентов. В зависимости от ситуации может проводится в ходе одного или нескольких визитов монитора (CRA) в исследовательский центр после получения всех разрешительных документов официальных инстанций и одобрения этического комитета. В ходе этой процедуры исследователям передаются все материалы клинического исследования, включая лекарственный препарат, детально обсуждаются процедуры протокола, требования к заполнению ИРК, ведению первичной документации. После того, как CRA убедится в том, что исследователю понятны предъявляемые требования и центр готов к исследованию, исследователи могут начинать набор пациентов.

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

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