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The Role of the Clinical Statistician in Understanding and Using ADaM Data Standards
Session Chair(s)
Steve Wilson, PhD
Senior Staff Fellow, OB, OTS, CDER, FDA, United States
Analysis data model (ADaM) datasets and associated documentation are critical elements in PFDUA V-mandated, CDISC-compliant biologics license application and new drug application submissions. Clinical statisticians must know how to create and use ADaM-based standards. This forum will briefly review ADaM concepts and will describe approaches currently used by a sponsor and a contract research organization to successfully meet submission requirements. Regulatory perspectives will also be examined.
Learning Objective : Describe the clinical statistician's role in creating analysis data model (ADaM)-based datasets and analyses; Discuss critical considerations in creating and using ADaM datasets/documentation; Identify several industry approaches to creating ADaM submission deliverables.
Speaker(s)
Considerations for ADaM Implementations
Diane Piper, MSc
Director Clinical Standards, Shire Pharmaceuticals, United States
Panelist
Rob Woolson, JD, MS
Chief Strategist, Regulatory Biostatistics and Standards, Rho, Inc., United States
Panelist
Weiya Zhang, PhD
Mathematical Statistician, OB, Office of Translational Science, CDER, FDA, United States
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