As technology advances, the electronic data flow between systems is more efficient and more prevalent. Understanding the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important. 21 CFR 11 helps ensure the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions. In this webinar, FDA will present the current thinking regarding 21 CFR 11 and its application to electronic records, electronic systems and electronic signatures during a clinical investigation.