The use of CDISC Standards in SAS from Data Capture to Reporting

This paper looks at how CDISC standards can be applied to data in a variety of SAS® applications commonly used during the clinical development process. Data originates in an EDC or CDMS system and is transferred to the SAS Data Integration Studio product in a raw or ODM structure. It is then transformed into an SDTM format using a number of features in SAS DI. From there, the SDTM format is loaded into SAS Drug Development where it can be accessed for reporting and analysis. Many of these steps can now be automated within the SAS tools, including comparison to the SDTM model, transferring the data from SAS DI to SAS DD, and making the SDTM model available to the Data Explorer component within SAS Drug Development. These technical features are explained, as are a number of alternative methods.