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.