This book provides a
brief introduction to the SAS Clinical Standards Toolkit. The SAS
Clinical Standards Toolkit serves two primary purposes:
-
Provide SAS implementations, based
in SAS, of evolving clinical data standards.
-
Provide a framework that exploits
these standards to meet common clinical research analysis and submission
requirements.
Through the SAS Clinical
Standards Toolkit 1.6
release, the SAS Clinical Standards Toolkit supports only standards
developed by the Clinical Data Interchange Standards Consortium (CDISC).
However, there is nothing in the product design that limits support
of other standards, and it is anticipated that both current users
and future SAS Clinical Standards Toolkit releases will support non-CDISC
clinical-related standards.
The SAS Clinical Standards
Toolkit is an open-source solution. Most of the code is either Base
SAS or SAS macro code. For XML-based standards, some Java and XSLT
code is used. The SAS Clinical Standards Toolkit is a SAS solution
for SAS users.
Because study design,
data collection, and analysis and submission requirements of each
research protocol are unique and because the SAS Clinical Standards
Toolkit provides libraries of open-source SAS macros and code, user
customization is expected and encouraged.