This session dives into the U.S. Food and Drug Administration (FDA) policies, guidance, and expectations regarding the collection, creation, and storage of electronic source documentation at study sites. An experienced FDA Investigator will share examples of modern electronic record creation tools, programs, and devices alongside real-world examples of deficiencies observed on inspections and how the deficiencies could be prevented at a clinical site.

CEU: 1.00 ACRP

Speaker:

Richard Berning, Foreign Cadre Investigator / Specialist, U.S. Food and Drug Administration

Watch a Sneak Peek into the Session Content: