Key SAS Clinical Standards Toolkit Components

Framework macros and SAS macros specific to a standard provide the foundation for the SAS Clinical Standards Toolkit functionality. Three other SAS Clinical Standards Toolkit components are also noteworthy:

driver programs
properties
SASReferences data set

The SAS Clinical Standards Toolkit provides a set of driver programs (non-macro SAS code) that illustrate all of the basic SAS Clinical Standards Toolkit functions using sample data provided by SAS. These drivers can serve as templates for the processes that you want to develop. These drivers might be submitted as batch or interactive processes. They can be found in the programs subfolder for each standard (for the relative location of this folder, see Folder Hierarchy for CDISC ADaM 2.1 Sample). For a more complete description of what these drivers do, see Using the SAS Clinical Standards Toolkit.

The SAS Clinical Standards Toolkit provides a series of framework properties files and properties files specific to a standard (such as initialization, validation, and report properties files). You can use these files to define global macro variables and to set their default values. These typically can be found in the same folders as the driver programs. Use of these property files is optional but recommended, and you can add your own global macro variables as needed.

Perhaps the single most important file used by the SAS Clinical Standards Toolkit is the SASReferences data set. The SASReferences data set captures all the input and output file library and file references associated with any process. Here is a sample:

Sample SASReferences Data Set (CDISC SDTM 3.1.2 Validation Process)

Here are some general observations about the sample SASReferences data set:

The type and subtype values are used by the SAS Clinical Standards Toolkit code to find the fileref or libref associated with a particular input or output file type.
The SASref can be any user-defined value.
An empty path tells the SAS Clinical Standards Toolkit to look for the default value from the metadata for a specific standard in the global standards library (usually a global standards library location).

A complete discussion of the SASReferences data set is provided in Chapter 6, “SASReferences File,” in the SAS Clinical Standards Toolkit: User's Guide. The SAS Clinical Standards Toolkit defines a standard SASReferences data set for each supported standard (found in the global standards library directory/standards/standard/control directory).