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...
Main Author: | |
---|---|
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 |