Overview

Each standard as defined in the SAS Clinical Standards Toolkit includes numerous SAS metadata files and SAS macros. For the SAS Clinical Standards Toolkit to function properly, each file must contain a core set of columns that have an expected variable type. Each macro is designed to use these core columns to perform certain functions.

The term internal validation refers to a set of tools that checks the consistency of the SAS metadata files. The tools use the SAS Clinical Standards Toolkit validation framework and methodology that assess standard-specific files against a defined reference standard. The tools determine whether the metadata that the SAS Clinical Standards Toolkit expects is correctly defined.

The primary design goals of internal validation include:

Verify that the metadata files that are provided with the SAS Clinical Standards Toolkit are consistent and correct.
Use this functionality to facilitate definition, registration, and validation of new user-defined custom standards.
Use the SAS Clinical Standards Toolkit validation framework whenever possible.
Limit the amount of new metadata that is required to support internal validation.
Enable the use of the functionality during product development as a part of the installation qualification process and operational qualification process and as users add new metadata or modify existing metadata.
Significantly expand the internal validation of SASReferences data sets beyond the use of the %CSTUTIL_CHECKDS autocall macro used in previous releases of the SAS Clinical Standards Toolkit.
Develop a suite of internal validation programs, tools, and validation processes that can be run independently or as part of a SAS Clinical Standards Toolkit process provided by SAS.

The SAS Clinical Standards Toolkit provides a representative sample of programs, tools, and validation processes to support internal validation, which are summarized in these scenarios:

Supported Internal Validation Scenarios
Scenario
Support installation qualification and operational qualification assessment and reporting
Assess metadata consistency across files
Determine the structural validity of a metadata file
Confirm valid content of a metadata file
Validate a SASReferences data set