Risks of clinical trial protocol amendments according to duration of the trial

Background. No clinical trial could be initiated and conducted without appropriate clinical trial protocol. Any change in information relating to patients’ safety and health during the trial must be recorded and approved by a form of amendment to the clinical trial protocol, which is a time-consumin...

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Bibliographic Details
Main Authors: A. A. Eleskina, N. V. Pyatigorskaya, O. V. Filippova
Format: Article
Language:Russian
Published: Izdatelstvo OKI 2023-07-01
Series:Качественная клиническая практика
Subjects:
Online Access:https://www.clinvest.ru/jour/article/view/662