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22 May ' 16:33
Clinical Standards Toolkit provides support of multiple CDISC standards, including SDTM (3.1.1, 3.1.2 and 3.1.3), CRT-DDS (reading and creating define.xml files), ODM (reading and creating 1.3.0 and 1.3.1 xml files), ADaM 2.1, and SEND 3.0. This tool is the platform used by SAS® to support Health and Life Sciences industry data model standards. SAS Clinical Standards Toolkit is under active development with continued releases planned in its product roadmap.
The set of new functionality provided in the recent release of SAS Clinical Standards Toolkit 1.5 includes:
- Introduction of the SAS Clinical Standards Toolkit Sample Library
- Introduction of a set of tools to validate Toolkit metadata
- CDISC-SDTM updates include:
- Full support of SDTM 3.1.3
- Rewrite of the SDTM check utility macro sdtmcheckutil_recordlookup to optimize performance
- CDISC-ODM updates include:
- Full support of ODM 1.3.1
- Support for the extraction of ODM Clinical and Reference data into SAS data sets
- CRT-DDS 1.0.0 (define.xml) updates:
- Create define.xml for ADaM
- Define value level metadata (SDTM)
- Define parameter value level metadata (ADaM)
- Define document metadata for annotated CRFs and supplemental documents (SDTM)
- Create define.pdf for SDTM and ADaM
- CDISC-ADaM 2.1 updates:
- Support for ADAE Version 1.0
- An sample implementation of ADTTE Version 1.0
- New validation checks in support of ADAE and ADTTE
- An initial implementation of the CDISC SEND 3.0 standard
- Introduction of the new CT 1.0.0 standard:
- Support for import of NCI CDISC Controlled Terminology (CT) in the ODM XML format
- Import samples for ADaM, CDASH, SDTM, SEND, Questionnaires, and the Clinical Data Element Glossary terminology
- Additional columns have been added to all SASReferences and StandardSASReferences data sets
- Full i18n multiple-byte character (UTF-8 and Shift JIS) support for clinical data
- Updates to previously supplied Framework macros
- New Framework macros, including new validation check and validation check utility macros
SAS Clinical Standards Toolkit 1.5 is supported with SAS 9.3 on the following operating systems:
Toolkit Version Availability 1.5 Available with SAS 9.3 (TS1M2) or later 1.4 Available with SAS 9.3 for releases prior to TS1M2 1.3 Available only on SAS 9.2 1.2 Available only on SAS 9.1.3 Windows. Download at http://ftp.sas.com/techsup/download/hotfix/12clintlkt.html. The installation instructions and Installation Qualification documentation are included with the download Version 1.5
- Using the SAS Clinical Standards Toolkit 1.5 for define.xml Creation (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (PharmaSUG 2013)
- Using the SAS Clinical Standards Toolkit 1.5 to import CDISC ODM files (.pdf) | and workshop materials (.zip) by Lex Jansen, SAS Institute Inc., Cary, NC (PharmaSUG 2013)
- SAS Clinical Standards Toolkit 1.5 - How Do I Know My Metadata is Right? (.pdf) | and the presentation (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (PhUSE 2012)
- Simplifying SAS Clinical Standards Toolkit - Where's the Easy Button? (.pdf) | and the presentation (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (PhUSE 2012)
- SAS Clinical Standards Toolkit: define.xml and Value Level Metadata (.pdf) | and the presentation (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (PhUSE 2012)
Version 1.4 and Earlier
What's Next?
to help guide development. For SAS Clinical Standards Toolkit 1.6, the following preproduction updates are under consideration:
- Support for CDISC-SDTM 3.1.4 (including any available Therapeutic Area and Device domains)
- Provide support for WebDAV and Oracle library and file access
- Full implementation of CDISC Define-XML 2.0
- Create define.xml for CDISC-SEND 3.0
SAS Clinical Standards Toolkit 1.6 is expected to be released on SAS 9.4, with consideration being given to release on SAS 9.3 as well.
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- The Implementation of Nested Value Level Metadata in the SAS Representation of the CRT-DDS v1.0.0 Model in the SAS Clinical Standards Toolkit (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (SAS Institute white paper 2012)
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08 Jun ' 15:09
- Using the SAS Clinical Standards Toolkit 1.4 for define.xml creation (.pdf) | and workshop materials (.zip) by Lex Jansen, SAS Institute Inc., Cary, NC (PharmaSUG 2012)
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24 Jan ' 17:36
- Dont have SAS installed? SAS learning software for professionals is available.
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06 Dec ' 16:18
Clinical Standards Toolkit 1.4 provides support of multiple CDISC standards, including SDTM (3.1.1 and 3.1.2), CRTDDS (reading and creating define.xml files), ODM (reading and creating 1.3.0 xml files) and ADaM 2.1. This tool is the platform used by SAS to support Health and Life Sciences industry data model standards. SAS Clinical Standards Toolkit is under active development with multiple releases planned in its product roadmap.
The recent release of SAS Clinical Standards Toolkit 1.4 provides full support of the CDISC-ODM 1.3.0 standard (reading and creating ODM xml files), the CDISC ADaM 2.1 standard (ADSL, Basic Data Structure and Analysis Results Metadata templates, as well as version 1.1 of the ADaM validation checks), and a CDISC Controlled Terminology package that includes the cumulative set of terminology as posted to the
- Windows x64
- Linux x64
- SAS 9.3
- SAS Clinical Standards Toolkit version 1.4 for SAS 9.3 must be ordered through normal channels. Contact your SAS representative to have SAS Clinical Standards Toolkit added to your existing SAS license(s) for no additional fee.
- SAS Clinical Standards Toolkit version 1.4 is not supported on SAS 9.2. SAS Clinical Standards Toolkit version 1.3 is currently available for SAS 9.2.
- SAS Clinical Standards Toolkit version 1.2 for SAS 9.1.3 Windows customers (not supported on UNIX) is available for download at
These papers introduce you to SAS Clinical Standards Toolkit and can help you understand how it functions.
- How to Register a New Custom Standard within the Clinical Standards Toolkit (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (SAS Institute white paper 2011)
- Using the SAS Clinical Standards Toolkit to Work with the CDISC ODM Model (.pdf) by Lex Jansen, SAS Institute Inc., Cary, NC (PhUSE 2011)
- Implementing ADaM Using SAS Clinical Standards Toolkit 1.4 (.pdf) by Gene Lightfoot, SAS Institute Inc., Cary, NC (PhUSE 2011)
- Using the SAS Clinical Standards Toolkit for define.xml creation (.pdf)
- Implementing, Managing, and Validating a Clinical Standard Using SAS Clinical Standards Toolkit 1.3 (.pdf)
- Define.xml - Tips and Techniques for Creating CRT-DDS (.pdf)
- The SAS Clinical Standards Toolkit (.pdf)
- Introduction to SAS Clinical Standards Toolkit (.pdf)
SAS and Clinical Trials community to help guide development. For SAS Clinical Standards Toolkit 1.5, the following preproduction updates are under consideration:
- Updates to the CDISC-ADaM model, such as ADAE and ADTTE
- Ability to create a define.xml file based on CDISC-ADaM content
- Additional CDISC-SDTM domains (such as those in support of medical devices and therapeutic areas) and changes captured in the SDTM Amendment 1
- Ability to create a printable (PDF) version of the define.xml file
- Support of value-level metadata for CDISC-CRTDDS
- Support of additional CDISC standards such as CDASH, SEND and PRM.
Check back with this site periodically for updates. Contact your SAS representative if any of these updates are of particular interest to you, or if you have other suggestions for product updates.
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