DM01
The CDISC Laboratory Data Interchange Standard: Using SASŪ To Read and Write CDISC Compliant Data Sets and Files
Margaret Hung, GlaxoSmithKline
Philip M Pochon, Covance Central Laboratory Services, Inc.

The Clinical Data Interchange Standards Consortium (CDISC) has released for public review and comment its data model for clinical trial laboratory data interchange (lab data model). The version 1 release of the laboratory data interchange model defines st andards for SAS data sets and ASCII files. This paper first reviews the key features of the CDISC lab data model and discusses planned future extensions to the model. It then focuses on the experiences gained during early testing of the model. This test ing evaluated processes for transferring central laboratory data to pharmaceutical companies. The testing used base SAS to generate and read SAS data sets and ASCII files. Testing was performed across multiple versions of SAS, and multiple operating syst ems. Testing methods are reviewed and sample SAS code is examined during a discussion of the issues discovered during testing.