Today’s FDA perspective on the role of electronic source data used in eClinical Systems

Communicate todays FDA compliance expectation with respect to the use of eSource Data in eClinical systems within the regulated pharmaceutical industry. Compare todays (draft) FDA standpoint with the current expectations defined by the European Union in the EMA Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials from Aug-2010. Summarize the US and the European similarities and discuss the differences between the draft Guidance and the Position paper. This session deals with applicable FDA requirements and case examples resulting from the enhanced use of electronic source data in today’s eClinical systems. Specific topics to be covered include 21 CFR Part 11, FDA's second revision of the Draft Guidance on Electronic Source Data in Clinical Investigations, and FDA GCP Compliance & Inspectional trends.