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Reliability of Data Results in Clinical Trials (ICH E6 (R2)): What Does it Mean and How Can it be Accomplished?
Session Chair(s)
Nathaniel P. Katz, MD, MS
Chief Science Officer, WCG Analgesic Solutions, United States
The purpose of this session is to delve into the meaning behind the ICH E6 (R2) goal of “reliability of data” and to present methods to measure, monitor, and improve the reliability of clinical trials and their component processes.
Learning Objective : Describe the ICH E6 (R2) guidance that states a sponsor must “ensure the reliability of study results”; Discuss how to improve the reliability and accuracy of clinical trial data through the application of scientific principles.
Speaker(s)
Jean M. Mulinde, MD
Associate Director, Division of Clinical Compliance Evaluation, OSI, FDA, United States
FDA Update
Emanuel S Troullos, DDS, MPH
Global Medical Affairs, Contract Employee, Belcan, United States
Reliability of Data Results in Clinical Trials
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