Data Management Report

Data Management Report
Отчёт о менеджменте данных
Отчет, который пишется в конце процесса обработки данных. Он должен содержать следующую информацию о данных проведенного исследования:
● местонахождение данных;
● структура данных;
● нарушения протокола исследования;
● специфические и общие комментарии к исследованию или ИРК;
● все справочные значения, которые использовались в связи с данными;
● описания любых проверок достоверности, предпринятых с целью проверки данных;
● программы, которые были использованы для анализа данных, вместе с информацией, касающейся использовавшихся путей обработки данных;
● информацию об использованных кодирующих словарях (названия и местоположение);
● резюме отчёта отдела по контролю за качеством;
● перечень всех сомнительных данных, выявленных при проверке.

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

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