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Polycystic Kidney Disease

Polycystic Kidney Disease (PKD) Therapeutic Area User Guide v1.0

1.0
Release Date: 26 Feb 2013

Version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, released 2013-02-26, is a provisional standard that provides guidance on implementing the Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. When used with the SDTMIG, the User Guide is intended to guide the organization, structure, and format of standard PKD clinical trial tabulation datasets for regulatory submissions. A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; it is subject to modification for certain component that are still in process. Any revisions to the draft or provisional domains and their publication status will be updated as needed in future versions of the PKD User Guide.