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Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
Session Chair(s)
Kay Weiler, BSN, JD, MA, RN
Vice President
CompleWare Corporation, United States
Innovative methods to detect potential GCP noncompliance before, during and/or after clinical trial execution have been developed. This forum discussion will present approaches from FDA and a sponsor.
This forum has been developed by the Good Clinical Practices and Quality Assurance Community.
Learning Objective : Describe an overview on the use of analytical methods to detect and monitor GCP noncompliance; Discuss FDA risk-based signal detection methods used for inspection site selection.
Speaker(s)
FDA Point of View
Ann Meeker-O'Connell, MS
FDA, United States
Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
Sponsor Perspective
C. Grant Simmons, MSc
Novartis Pharmaceuticals Corporation, United States
Head, ClinOps Analytics and Systems, Global Operations Services, IDFR
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