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Lessons Learned from FDA-sponsored ARRA PCOR (American Recovery and Reinvestment Act Patient Centered Outcomes Research) Data Standardization Efforts
Tuesday, June 26, 2012
10:00 AM to 11:30 AM
Crystal Allard, FDA, United States
Amy Malla, MT(ASCP), PMP, CQA with FDA's Center for Biologics (CBER), Review Management . Her responsibilities include implementation of CDISC data standards and Janus. Amy also holds certifications as a Medical Technologist, Project Manager, Six Sigma Black Belt and Certified Quality Auditor.
Ted Peterson, FDA, United States
Dr. Rosario is Associate Director in the FDA’s Office of Science and Innovation. She holds a Ph.D. in Neuroscience from Rutgers University and a B.A. in Chemistry from the University of Puerto Rico.
Helena began her career in pharmaceutical research . In 2001, was awarded an MPH in epidemiology. She has participated in many large-scale, population analyses. She was at a CRO in 2007 when they won one of the first legacy data conversion contract from CDER. She joined FDA in 2010.
FDA would like to share their experiences in standardization of data at each center. Each speaker will discuss the most valuable lessons they have learned during the conversion process including outstanding technical and policy issues.
Discuss lessons learned while standardizing clinical data
Identify technical and policy issues that require follow-up
Discuss implications and impact of standardized data on FDA review and analytical utility Discuss specific examples of utility of standardized data across studies.
Audio Synchronized to PowerPoint