Risk-based monitoring: Review of the current perceptions and toward effective implementation

The United States Food and Drug Administration issued a guidance to industry in August 2013 on risk-based approach to monitoring. This prompted industry (sponsors and contract research organizations) to brainstorm, conceptualize, and implement risk-based monitoring (RBM) in their clinical studies an...

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Bibliographic Details
Main Author: Veena Shridhar Jaguste
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2019-01-01
Series:Perspectives in Clinical Research
Subjects:
Online Access:http://www.picronline.org/article.asp?issn=2229-3485;year=2019;volume=10;issue=2;spage=57;epage=61;aulast=Jaguste