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Electronic Submissions - The Requirement for Standardized Study Data Mary Ann Slack Deputy Director, Office of Strategic Programs Ron Fitzmartin, PhD, MBA Sr. Advisor, Office of Strategic Programs Center for Drug Evaluation and Research Food and Drug Administration FDA Webinar 9 February 2015 1 Path to Electronic Standardized Study Data Final eStudy Data Guidance Tech Conformance Guide 1980s FDA Clinical / Statistical Sections Guideline SAS Datasets or ASCII FDA Support for SAS XPT CDISC-FDA Collaboration 1999 2004 FDA Support for Final 745A(a) Guidance CDISC Submissions FDASIA PDUFA V 2 2012 2014 Common Tools Value Proposition for Study Data Standards Replication Predictability Traceability Data Quality Transparency Interoperability Aggregation Tools Interchange Improve Efficiency & Decision-making 3 FY2013, FY2014, FY2015(Q1) Number (%)
Electronic Submissions - The Requirement for Standardized Study Data Mary Ann Slack Deputy Director, Office of Strategic Programs. Ron Fitzmartin, PhD, MBA
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