What's New

What's New in the SAS 9.2 CDISC Procedure

The SAS 9.2 CDISC procedure supports validating a SAS data set against CDISC (Clinical Data Interchange Standards Consortium) Study Data Tabulation Model (SDTM) standards. In addition, several enhancements are implemented for importing and exporting a CDISC Operational Data Model (ODM) XML document.

CDISC SDTM Validation Support

PROC CDISC performs data content validation on a SAS data set that conforms to CDISC SDTM version 3.1. PROC CDISC validates the SAS data set against domains that are provided by CDISC SDTM. See Validating a CDISC SDTM SAS Data Set, and CDISC Procedure for CDISC SDTM.

Enhanced CDISC ODM Support

For a CDISC ODM XML document, PROC CDISC provides the following changes:

There is no longer an ODM normative document (ODM-ND) non-conformance issue. The SignificantDigits attribute (decimal precision) in an ItemDef element for a floating-point value (DataType=float) that is required by the ODM-ND is now generated.
PROC CDISC behavior for handling SAS data set (ItemGroupDef element), variable (ItemDef element), and format (CodeList element) names is controlled by the new LONGNAMES= processing option. See ODM Statement. The option determines the sources of captured SAS name parameters and controls the maximum length of SAS names that is valid.
PROC CDISC produces a directory listing of the CDISC ODM XML document with the DATASETS statement, and PROC CDISC describes the contents of a CDISC ODM SAS data set with the CONTENTS statement. See CONTENTS Statement and DATASETS Statement.
The PROC CDISC statement now includes the LANGUAGE= option to specify a language identifier. See PROC CDISC Statement for CDISC ODM.
The ORDERNUMBER= processing option determines whether PROC CDISC validates OrderNumber attributes when you import a CDISC ODM XML document. See ODM Statement.
PROC CDISC behavior to determine the sources of captured SAS data set and variable labels is controlled by the new USENAMEASLABEL= processing option. See ODM Statement.
The CLINICALDATA statement now supports the INVESTIGATORREF= option to determine whether to import the unique identifier for the investigator user, and the SITEREF= option to determine whether to import the unique identifier for the clinical data study location. See CLINICALDATA Statement.

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