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Session 3 Track 3 - Update on Status of PhUSE – Inspection Site Selection Standard Data Elements Working Group
Session Chair(s)
Betsy Fallen, RN
Consultant
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 FDA published a Draft Guidance in 2012 and is working on an update.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.
Speaker(s)
Office of Scientific Investigations - Bioresearch Monitoring (BIMO) Selection of Clinical Sites for Inspection - Sponsor Perspective
Colleen Davenport, PHD
Radius Health, United States
Vice President Regulatory Affairs
CDISC Perspective
Nate Freimark
Theorem Clinical Research, United States
Senior Director, Biometrics Operating Standards Group
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