What's New in the SAS Clinical Standards Toolkit
Overview
Here are the significant
new capabilities in the SAS Clinical Standards Toolkit 1.6:
-
Pointers to the global standards
library and the sample study library
For SAS 9.4, two SAS
options have been added: CSTGLOBALLIB and CSTSAMPLELIB. These are
pointers to the global standards library and the sample study library.
Prior to version 1.6
of the SAS Clinical Standards Toolkit, a post-processing step modified
the cstutil_setcstgroot and cstutil_setcstsroot macro programs to
point to the global standards library and the sample study library
as defined during installation. This post-processing step set the
proper values for the global macro variables _cstGRoot and _cstSRoot.
With version 1.6 of
the SAS Clinical Standards Toolkit, use these SAS options to specify
the locations:
-
CSTGLOBALLIB specifies the SAS
Clinical Standards Toolkit global standards library.
-
CSTSAMPLELIB specifies the SAS
Clinical Standards Toolkit sample study library.
In SAS Clinical Standards
Toolkit 1.6, the framework macros cstutil_setcstgroot and cstutil_setcstsroot
have been modified to run in either SAS 9.3 or SAS 9.4.
To provide seamless
functionality between the two supported versions of SAS, two new framework
macros have been added: cstutilsetcstgroot93 and cstutilsetcstsroot93.
In SAS 9.3, these macros
are initialized in the post-processing step and are called by their
respective macros: cstutil_setcstgroot and cstutil_setcstsroot.
In SAS 9.4, the macros
cstutil_setcstgroot and cstutil_setcstsroot reference the new SAS
options CSTGLOBALLIB and CSTSAMPLELIB.
-
The macro cstcreatetablesfrommetadata
has been added. This macro generates table shells from table and column
metadata data sets provided to the macro. The usual source of this
metadata is a define.xml file, but the macro is designed to work with
SAS data sets to allow more flexibility when creating source metadata.
The macro generates table shells with only the information that it
is given, and it does not access the SAS Clinical Standards Toolkit
reference metadata to add any missing columns. For complete information
about this macro, see the
SAS Clinical Data Standards Toolkit:
Macro API Documentation.
-
For the CRT-DDS 1.0 data standard,
the SAS Clinical Standards Toolkit no longer creates values for the
ODM/@Id and ODM/@AsOfDateTime attributes. These attributes are not
part of the CRT-DDS 1.0 specification. Furthermore, if the data type
is equal to
float and the DisplayFormat
attribute is specified, the SAS Clinical Standards Toolkit attempts
to derive the ItemDef/@SignificantDigits attribute.
-
The macro cstutilxmlvalidate has
been added. This macro replaces the data standard-specific macros
crtdds_xmlvalidate.sas, ct_xmlvalidate.sas, and odm_xmlvalidate.sas,
which are deprecated and will be removed from SAS Clinical Standards
Toolkit 1.7.
-
The global macro variables _cstLRECL
and _cstVersion have been added.
_cstLRECL specifies
the LRECL (logical record length) length for files. Prior to version
1.6 of the SAS Clinical Standards Toolkit, this value was inconsistent.
The value of _cstLRECL is set to
2048.
_cstVersion specifies
the current version of the SAS Clinical Standards Toolkit. The value
of _cstVersion is set to
1.6.
Both of these variables
are in the framework 1.6 initialize.properties file, which is located
in
global standards library directory/programs.
-
A set of metadata management macros
has been added to support updates to the SAS Clinical Standards Toolkit
metadata.
For
more information, see Metadata Management.
CDISC SDTM
Here are the significant
changes to CDISC SDTM in SAS Clinical Standards Toolkit 1.6:
-
CDISC SDTM 3.2 data standard
The CDISC SDTM 3.2
data standard, including all metadata and validation checks, is fully
implemented. This includes the definitions of 57 domains that are
itemized in these documents:
-
Study Data Tabulation
Model Implementation Guide: Human Clinical Trials Version 3.2
-
Study Data Tabulation
Model Version 1.4
-
Study Data Tabulation
Model Implementation Guide: Associated Persons Version 1.0
-
Study Data Tabulation
Model Implementation Guide for Medical Devices (SDTMIG-MD) Version
1.0
-
CDISC SDTM 3.1.1 standard
Effective with SAS
Clinical Standards Toolkit 1.7, the CDISC SDTM 3.1.1 reference standard
will no longer be supported. The SDTM 3.1.1 subfolder hierarchy will
be removed from the global standards library and the sample study
library.
Define-XML 2.0
SAS Clinical Standards
Toolkit 1.6 contains an initial implementation of the CDISC Define-XML
2.0 standard. The standard describes CDISC SDTM, SEND, and ADaM data
sets for the purpose of submitting information to the FDA. This standard
also describes data set structures that are not based on CDISC.
Define-XML version 2.0
can be used to transmit metadata for the following CDISC standards:
-
SDTM Implementation Guide Versions
3.1.2 and higher
-
ADaM Implementation Guide Versions
1.0 and higher
-
SEND Implementation Guide Versions
3.0 and higher
The implementation includes:
-
A complete definition of the metadata
model for CDISC Define-XML 2.0.
-
Creation of a complete Define-XML
2.0 file based on study metadata with study metadata examples from
SDTM 3.2 and ADaM 2.1.
-
Validation of a Define-XML 2.0
file against the XML schema definition as published by CDISC.
-
Importation of a Define-XML 2.0
file into the SAS representation of the Define-XML 2.0 metadata model.
CDISC Controlled Terminology
The SAS Clinical Standards
Toolkit support for controlled terminology has been updated to the
most recent version of the NCI CDISC controlled terminology as of
January 1, 2014.
This table lists the
implemented controlled terminology versions. Every controlled terminology
standard (ADaM, CDASH, SDTM, SEND, and Questionnaire) contains a current folder,
which is a copy of the most recent controlled terminology version
for that standard.
Implemented Controlled Terminology
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