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Why Waste Time and Money? Data Standards from the Beginning: Working Together for Good Science and Good Submissions
Session Chair(s)
Ron Fitzmartin, PhD, MBA
Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States
PDUFA V has shined the light on data standards. Everyone recognizes that our trial and reporting processes need to be more effective and efficient. We need to use accepted data standards throughout the clinical data life cycle. With this new awareness and urgency, a number of players (eg, FDA, NCI, CDISC, the C-Path Institute, TransCelerate, and FDA) are working together to make it happen. What do we all want/need? What does this coordinated vision of collaborative standards development and effective application look like? Are we truly coordinating and collaborating across these organizations, so that we can put all of the many pieces together. This session will discuss standards development for this clinical data life cycle, discussing the goals, objectives, and progress of some of the many organizations engaged in this quest.
Learning Objective : Discuss the clinical data life cycle; Assess how mapping after data capture can compromise traceability and regulatory review quality/efficiency; Illustrate how to design data capture systems based on protocol templates and CDISC/CDASH standards.
Speaker(s)
FDA Perspective
Benjamin Peter Behrang Vali, MS
FDA, United States
Regulatory Affairs Officer and Project Manager, DGIEP, OND, CDER
Protocol Standardization, Common Protocol Templates, and Data Standards: Streamlining Clinical Development
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
Realizing the Promise of End-to-End Standards through CFAST and CDISC SHARE
Wayne R. Kubick, MBA
HL7 International, United States
Chief Technology Officer
Panelist
Paula Brown Stafford, MPH
Health Decisions, Inc., United States
Board of Directors; Biopharmaceutical Services Executive
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