What's New in the SAS Clinical Standards Toolkit

Overview

Here are the significant new features in the SAS Clinical Standards Toolkit 1.7:
  • Macro changes
  • Support for CDISC CDASH 1.1
  • Support for CDISC Dataset-XML 1.0
  • Additional support for CDISC Define-XML 2.0
  • Reduced and consolidated validation_master data sets for SDTM 3.1.2, 3.1.3, 3.2, and ADaM 2.1
  • Support for the Analysis Results Metadata 1.0 extension for Define-XML 2.0

Macro Changes

Here are the changes to macros that have been made in the SAS Clinical Standards Toolkit 1.7:
  • The framework macro %CSTUTILMANAGECOLUMNSIZE has been added.
    This macro provides options to change the size of a column to the observed length or the expected length. This macro is useful for reducing the size of a data set to conform to regulatory submission guidelines. For complete information about this macro, see the SAS Clinical Standards Toolkit: Macro API Documentation.
  • The macro %CSTUTILCOMPAREMETADATASASDEFINE has been added.
    This macro compares the metadata in a CRT-DDS 1.0 or Define-XML 2.0 define.xml file with the metadata in the SAS Version 5 XPORT transport files or in the SAS data sets. For complete information about this macro, see the SAS Clinical Standards Toolkit: Macro API Documentation. For more information about the standards, see XML-Based Standards.
  • The macros %CSTUTILSQLCOLUMNDEFINITION, %CSTUTILSQLGENERATETABLE, and %CSTUTILFINDFIXEXTDASCIICHARS have been added.
    The macros help you develop content for a new standard or study. Here are the functions that they perform:
    • create SAS Clinical Standards Toolkit metadata files
    • create SQL code that generates data sets based on column definitions in SAS Clinical Standards Toolkit metadata files
    • replace extended ASCII characters with characters that are acceptable to SAS
  • The macro %CSTUTILREGISTERCTSUBTYPE has been added.
    This macro supports updates to the SAS Clinical Standards Toolkit metadata. This macro enables the registration of a new set of controlled terminology to the global standards library directory/standards/cdisc-terminology-1.7/control/standardsubtypes.sas7bdat data set. For more information, see Metadata Management.
  • The standard-specific macros crtdds_xmlvalidate.sas, ct_xmlvalidate.sas, and odm_xmlvalidate.sas are no longer available in the SAS Clinical Standards Toolkit 1.7. These macros have been replaced by the %CSTUTILXMLVALIDATE macro.

Support for CDISC CDASH 1.1

Support for the CDISC CDASH 1.1 standard has been added. This support includes definitions of the 16 domains that are included in the following documents:
  • Clinical Data Acquisition Standards Harmonization (CDASH) Standard (Version 1.1, January 18, 2011)
  • Clinical Data Acquisition Standards Harmonization (CDASH) User Guide (Version 1-1.1, April 12, 2012)
For a description of the implementation, see CDISC CDASH 1.1.

Support for CDISC Dataset-XML 1.0

The CDISC Dataset-XML 1.0 data standard has been implemented. It can be used to transport CDISC SDTM, SEND, and ADaM data sets as part of a submission to the FDA. It supports proprietary (non-CDISC) tabular data structure for data transfer between two parties.
The implementation includes these features:
  • create Dataset-XML 1.0 files from study data with study data examples from SDTM 3.1.2 and ADaM 2.1
  • validate a Dataset-XML 1.0 file against the XML schema definition as published by CDISC
  • import Dataset-XML 1.0 files into SAS data sets with study data examples from SDTM 3.1.2 and ADaM 2.1
  • compare SAS data sets created from original SAS study data and SAS study data that was imported from Dataset-XML 1.0 files
For a description of the implementation, see CDISC Dataset-XML.

Additional Support for CDISC Define-XML 2.0

Four macros have been added to support creating an initial version of the SAS source metadata data sets source_study, source_tables, source_columns, source_codelists, source_values, and source_documents. These data sets are entered to create a Define-XML 2.0 file.
Here are the macros:
  • %DEFINE_CREATESRCMETAFROMSASLIB, which derives source metadata files from a data library that contains SAS study domain data sets
  • %DEFINE_CREATESRCMETAFROMDEFINE, which derives source metadata files from a data library that contains the SAS representation of a Define-XML 2.0 define.xml file for a study
  • %CSTUTILMIGRATECRTDDS2DEFINE, which migrates source metadata data sets from CRT-DDS 1.0 to Define-XML 2.0
  • %CSTUTILGETNCIMETADATA, which creates the source_codelists data set from a list of format catalogs that define the study formats and a SAS data set that contains CDISC/NCI codelist metadata
For more information about these macros, see Special Topic: Creating Study Source Metadata to Create a CDISC Define-XML 2.0 define.xml File.
Note: The macros %DEFINE_CREATESRCMETAFROMSASLIB, %DEFINE_CREATESRCMETAFROMDEFINE, and %CSTUTILMIGRATECRTDDS2DEFINE also create the source_analysisresults SAS data set. This data set is entered to create a Define-XML 2.0 file that includes Analysis Results Metadata.

Reduced and Consolidated validation_master Data Sets for SDTM 3.1.2, 3.1.3, 3.2, and ADaM 2.1

The validation_master data sets for SDTM 3.1.2, 3.1.3, 3.2, and ADaM 2.1 have been reduced and consolidated for each standard to represent only the validation checks provided by SAS. These validation checks enhance third-party checks to provide consistent standard metadata and to ensure data quality for each standard.
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