Confidentiality (regarding trial subjects)

Confidentiality (regarding trial subjects)
Конфиденциальность (в отношении испытуемых)
Сохранение в тайне информации об испытуемых, включая идентифицирующие их данные и всю персональную медицинскую информацию. Если при проверке данных необходим доступ к такой информации, она может проводиться только уполномоченным лицом. Данные, позволяющие идентифицировать испытуемого, должны всегда оставаться конфиденциальными. Перед началом клинического испытания необходимо получить согласие испытуемого на использование его медицинских записей при проверке данных; при этом должны быть даны заверения, что будет соблюдаться конфиденциальность. При сообщении информации о побочных явлениях либо любой другой информации спонсору и/или соответствующим инстанциям исследователь должен гарантировать, что тайна личной информации сохранена. Должно быть указано имя исследователя, сообщившего о побочном явлении.

English-Russian glossary of clinical practice. 2002.

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