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 SAS Clinical Standards
Toolkit metadata files that are provided by SAS 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 releases prior to SAS Clinical Standards Toolkit
1.5.
-
Develop a suite of internal validation
programs, tools, and validation processes that can be run independently
or as part of any SAS Clinical Standards Toolkit process provided
by SAS.
The SAS Clinical Standards
Toolkit 1.5 provides a representative sample of programs, tools, and
validation processes to support internal validation. Future releases
are expected to more fully address all of the design goals and to
better support and expand several of the following usage scenarios:
Status of Internal Validation Development
|
|
SAS Clinical Standards
Toolkit 1.5 Status
|
Support installation
qualification and operational qualification assessment and reporting
|
Available; future additions
planned
|
Support registration
of a new standard and updates to an existing standard
|
|
Assess metadata consistency
across files
|
Available; future additions
planned
|
Determine the structural
validity of a metadata file
|
|
Confirm valid content
of a metadata file
|
Available; future additions
planned
|
Validate a SASReferences
data set
|
|
Evaluate validation
check metadata
|
|