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 1.5 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.
Given that study design,
data collection, and analysis and submission requirements of each
research protocol are unique, and that the SAS Clinical Standards
Toolkit provides libraries of open-source SAS macros and code, user
customization is expected and encouraged.