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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 3 Track 3 - Update on Status of PhUSE – Inspection Site Selection Standard Data Elements Working Group

Session Chair(s)

Betsy  Fallen, RN

Betsy Fallen, RN


BAFallen Consulting LLC, United States

In order to verify the integrity of data submitted to the FDA, CDER has developed a risk-based inspection site selection tool that combines data from both Sponsor and FDA databases to evaluate clinical site level data for selection of clinical sites for inspection. FDA published a Draft Guidance in 2012 and is working on an update. A voluntary working group, the Inspection Site Selection Standard Data Elements Working Group, is currently evaluating how to incorporate site selection data set variables into existing standards (CDISC). The group will provide an update on their efforts which include a gap analysis to compare FDA requirements and CDISC standards.


Radius  Davenport, PhD

Office of Scientific Investigations - Bioresearch Monitoring (BIMO) Selection of Clinical Sites for Inspection - Sponsor Perspective

Radius Davenport, PhD

Radius Health, United States

Vice President Regulatory Affairs

Nate  Freimark

CDISC Perspective

Nate Freimark

Theorem Clinical Research, United States

Senior Director, Biometrics Operating Standards Group

Jean M. Mulinde, MD

FDA Update on CDER’s Clinical Investigator Site Selection Tool

Jean M. Mulinde, MD

FDA, United States

Associate Director, Division of Clinical Compliance Evaluation, OSI

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