The SAS Clinical Standards Toolkit File Roadmap

The SAS Clinical Standards Toolkit files can be aggregated into three primary groups:

The primary function of the SAS Clinical Standards Toolkit global standards library is to provide the metadata that defines each supported SAS Clinical Standards Toolkit standard. This location is specified during product installation and can be subsequently moved to another location. By default, on Microsoft Windows, this location is set to the c:\cstGlobalLibrary directory.

The metadata folder contains key metadata about all supported standards and can be updated with each new product release. The metadata folder can also be updated each time you elect to register a new standard or version of a standard. The schema-repository and xsl-repository folders support XML-based standards (such as CDISC-ODM and CDISC CRT-DDS). The standards folder contains a subfolder hierarchy for each supported standard.

The control folder contains data sets that provide general metadata about the standard. The macros folder contains SAS macros for standards that are included in the SAS autocall path when working with that standard. The messages folder contains messages used in reporting or process results for a specific standard. The metadata folder contains the “gold-standard” definition of the standard as interpreted and implemented by the person who registered the standard. The programs folder contains programs and property files supporting general use of the standard. The validation folder and the control folder contain validation check metadata for those standards supporting validation of standard domains or data sets.

Installation of the SAS Clinical Standards Toolkit places files in the !sasroot tree for the common SAS Clinical Standards Toolkit framework files. The generic (cross-standard or standard-independent) framework SAS macros are installed to the !sasroot/cstframework/sasmacros directory (Microsoft Windows). The SAS config file has been altered when the SAS Clinical Standards Toolkit was installed to include this folder, by default, in the SASautos path, meaning that the framework macros are available to you whenever and however you start SAS referencing the default config file.

In the SAS Clinical Standards Toolkit sample library, there is a sample folder for each standard. A sample folder contains the files that represent a sample SAS implementation of the specific standard, sample study data sets, and sample programs and results that illustrate the SAS Clinical Standards Toolkit functionality.

The folder hierarchy might be different for other standards. For example, the CDISC ADaM analysis folder and subfolders are unique to ADaM. The cstSampleLibrary folder merely provides a location for the sample SAS implementation. Your files can be located anywhere accessible by SAS. You do not need to conform to the folder-naming convention illustrated in the CDISC ADaM sample.