CDISC Data Standards: A Statistical Reviewers’ Perspective
*Weiya Zhang, FDA Keywords: Guidance, CDISC, Data Standards, SDRG, ADRG, Statistical Review The Prescription Drug User Fee Act (PDUFA V) set goals for FDA to develop guidance for industry on the use of CDISC data standards for the electronic submission of study data in applications. Many applicants are currently submitting CDISC compliant datasets in NDAs/BLAs. What are the advantages and challenges in using CDISC datasets for statistical review? How do the SDRG (Study Data Reviewer’s Guide) and ADRG (Analysis Data Reviewer’s Guide), developed in collaboration with PhUSE, help reviewers understand the relationships between the submitted data and the study report? In this presentation, the speaker will share review experiences with standardized data and related documentation, describing: 1) current CDER guidance requiring the submission of study data in conformance with CDISC standards; 2) the statistical review of CDISC-based submissions; and 3) the use of the SDRG and ADRG to support review.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC