Online Program

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Thursday, September 13
Thu, Sep 13, 2:45 PM - 4:00 PM
Lincoln 5
Investigating Data Anomalies

Data Anomaly Detection in CDER: An Overview of Efforts and Methods (300735)

*Paul H Schuette, FDA/CDER 

Keywords: data quality, data integrity, signal detection

In this talk, we will provide an overview of data anomaly detection efforts in the Center for Drug Evaluation and Research (CDER), with an emphasis on the available tools. We discuss why such tools are necessary and some of their inherent limitations. We also discuss some ongoing concerns with data quality and integrity and how sponsors and contract research organizations can help address those concerns.