Data Query Found by the Monitor
- Data Query Found by the Monitor
Проблемные данные (выявленные монитором)
Данные, вызывающие у монитора сомнения в их достоверности, либо допускающие неоднозначную интерпретацию.
Большинство вопросов по поводу проблемных данных должны быть разрешены монитором исследования непосредственно в исследовательском центре. Эти вопросы разрешаются в процессе обсуждения с исследователем, который и вносит все необходимые исправления в ИРК, датирует их и подписывает своими инициалами. Если проблемные данные были выявлены монитором после того, как ИРК были доставлены в офис КИО, то они заносятся в список проблемных данных, который направляется вместе с фотокопией соответствующей страницы ИРК исследователю для прояснения.
English-Russian dictionary of terms used in the conduct of clinical trials on medicinal products.
2013.
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