CDISC procedure

Operational Data Model (ODM). The ODM is a powerful XML-based data model that allows for XMF-based transmission of any data involved in the conduct of clinical trials. SAS has provided support for importing and exporting ODM files via the CDISC procedure and the XML LIBNAME engine. 

PROC CDISC is a new SAS procedure that is available as a hotfix for SAS 8.2 and ships as part of SAS 9.1.3. PROC CDISC is a procedure that allows you to import (and export) XML files that are compliant with the CDISC ODM version 1.2 schema. Here is a two-observation sample demographics ODM file that you might want to import into SAS ... 

Once the raw clinical data have been imported into SAS, the next step is to transform those raw data into more useful analysis-ready data. Raw data here mean data that have been imported without manipulation into SAS from another data source. That data source is likely to be a clinical data management system, but it could also be external laboratory data, IVRS data, data found in Microsoft Office files, or CDISC model data serving as the raw data. These raw data as they exist are often not ready for analysis. There may be additional variables that need to be defined, and the data may not be structured in a way that is required for a particular SAS analysis procedure. So once the raw data have been brought into SAS, they usually require some kind of transformation into analysis-ready files, which this chapter will discuss. 

O PROC CDISC requires a number of parameters that specify the clinical trial metadata not typically found in your SAS data sets. These parameters can be specified within PROC CDISC or in separate data sets that can be passed to the procedure. This example chooses the latter method. 

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