TITLE

USING ePRO SOLUTIONS TO COMPLY WITH THE FDA GUIDANCE ON PROSPECTIVE ASSESSMENT OF SUICIDALITY

PUB. DATE
July 2011
SOURCE
Pharma Magazine;Jul/Aug2011, Vol. 7 Issue 4, p26
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article focuses on the guidance document which was released by the U.S. Food and Drug Administration (FDA) on suicidality monitoring. It says that the Columbia-Suicide Severeity Rating Scale (C-SSRS) was identified by the FDA as an acceptable prospective assessment instrument that demonstrated clinical reliability and validity in more than 30,000 applications. It adds that C-SSRS has various benefits such as the identification of suicidality risks with timely feedback.
ACCESSION #
64156871

 

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