U.S. Food and Drug Administration (FDA) Investigators have uncovered data integrity issues related to electronic data in clinical trials, resulting in regulatory actions and/or FDA withholding of approval. This presentation will provide insight into electronic data on efficacy and safety and some real-world examples of questionable validity that the FDA has seen recently.

CEU: 1.00 ACRP

Speaker:

Craig Garmendia, PhD, MS, Investigator, International Inspection Cadre, U.S. Food and Drug Administration

Related Blog Content:

Getting Ahead of Tech-Related Data Integrity Challenges

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