Risk evaluation and mitigation strategy assessments: Social science methodologies to assess goals related to knowledge

Abstract

This PDF document was made available from www.rti.org as a public service of RTI International. More information about RTI Press can be found at http://www.rti.org/rtipress. RTI International is an independent, nonprofit research organization dedicated to improving the human condition by turning knowledge into practice. The RTI Press mission is to disseminate information about RTI research, analytic tools, and technical expertise to a national and international audience. RTI Press publications are peer-reviewed by at least two independent substantive experts and one or more Press editors. All rights reserved. This report is protected by copyright. Credit must be provided to the author and source of the document when the content is quoted. Neither the document nor partial or entire reproductions may be sold without prior written permission from the publisher. This paper provides a brief background and presents the written responses that RTI-HS submitted to the FDA, with modest revisions to add context and clarity to the response for a wider readership. We also briefly discuss upcoming US and European steps in this field.