Global Standards Library

The global standards library is the metadata repository for the SAS Clinical Standards Toolkit. By default, the global standards library contains the metadata for the Framework module and the metadata for each data standard that is provided with the SAS Clinical Standards Toolkit (such as the CDISC SDTM 3.1.2 standard).

During the installation and configuration of the SAS Clinical Standards Toolkit, you are prompted for the location where the global standards library should be installed. The configuration process creates a series of directories in this location.

The logs directory contains one data set: transactionlog. This data set is populated only by the metadata management macros. The data set can be updated by one or more users depending on how the SAS Clinical Standards Toolkit is implemented (file server installation or single installation on a laptop). The data set contains metadata update information from all users.

The metadata directory contains three data sets and one XML file: Standards, Standardlookup, StandardSASReferences, and availabletransforms.xml. The Standards data set has a list of the registered standards and basic information relating to each standard.

The StandardSASReferences data set defines the typical inputs and outputs of SAS processes that are associated with each standard.

The type and subtype columns can be used to reference information that the SAS Clinical Standards Toolkit needs. This information is in the directory structures and file naming standards used by the customer. A full list of valid types and subtypes are provided in this document.

The standards directory contains subdirectories for each of the standard versions that is provided with the SAS Clinical Standards Toolkit. In addition, there are subdirectories for user-customized versions of these standards and any new user-defined standards. Each subdirectory should be considered a stand-alone module. This is how the SAS Clinical Standards Toolkit can keep parallel standards and reduce the need for revalidation. Within each subdirectory, there might be directories that group the files, data sets, and housekeeping programs.

The Standardlookup data set contains discrete lookup values specific to a SAS Clinical Standards Toolkit registered standard. It provides specific information for column values and data set template names. In addition, this data set is used to perform internal validation of the SAS Clinical Standards Toolkit.

The availabletransforms.xml file is for XML-based standards. It defines the location of the XML schema, the location of the XSL transformation style sheets, and the import and export locations of XML documents.

The schema-repository directory contains XML schema definitions that are used to validate XML files. Standards that use XML should have their schemas in this directory so that they can be found. For example, the schema-repository directory for CDISC CRT-DDS 1.0 as defined in the Standards data set maps to this location:

See Global Standards Library: Metadata Standards Data Set, row 2, schema column.

The xsl-repository directory contains files that are used to transform XML files from one format to another. For example, the default style sheet directory for CDISC CRT-DDS 1.0 define.xml files created by the SAS Clinical Standards Toolkit as defined in the Standards data set maps to this location:

See Global Standards Library: Metadata Standards Data Set, row 2, exportxsl column.