SAS^® and the Clinical Data Interchange Standards Consortium (CDISC)

The importance of data standards

In the Spotlight Podcast Transcript of "Integrating Eclinical and EDC"(PDF) Landen Bain from CDISC explores the integration of electronic health records with clinical research.

The solution is to make use of data standards, such as those from CDISC, to provide more efficient and effective use of medical information by all members of the healthcare and life sciences ecosystem.

SAS CDISC participation
With a strong commitment to the development and implementation of data standards in life sciences, SAS has been a member and ardent supporter of CDISC since 2000. SAS' involvement in CDISC includes:

SAS^® software support for CDISC standards
In addition to helping define CDISC standards, SAS is making certain that our products and solutions support the implementation of CDISC data standards. The SAS^® Clinical Standards Toolkit provides support for clinical data standards in Base SAS. The toolkit supports:

• The definition of data standard domains.
• Conversion of domains between CDISC models.
• Validation and conformance checks.
• CRT-DDS (define.xml) creation.

Currently licensed Base SAS customers can order the SAS Clinical Standards Toolkit from SAS at no additional cost.

• After completing the required paperwork, SAS 9.2 customers will receive the software through their normal software delivery channel.
• A hot fix to provide toolkit support for Base SAS 9.1.3 Windows customers is available for download at http://ftp.sas.com/techsup/download/hotfix/12clintlkt.html.
• The SAS Clinical Standards Toolkit 1.2 User's Guide is available at http://support.sas.com/documentation/onlinedoc/clinical/.

SAS^®9 includes a component called PROC CDISC that enables organizations running SAS programs to work with CDISC structured data. PROC CDISC supports bi-directional conversion of data content contained in a CDISC ODM XML document to and from data sources that are accessible through SAS.

SAS recommends using the SAS Clinical Standards Toolkit to create define.xml instead of PROC CDISC. The toolkit is in active development with several additional releases planned. PROC CDISC is maintenance only – no new features will be added.

CDISC standards such as SDTM, ODM, LAB and ADaM can be effectively implemented in solutions like SAS Drug Development and SAS for clinical data integration. SAS for clinical data integration adds relevant functionality to our award-winning data integration software to scale clinical data integration processes without the need to write SAS code.

SAS CDISC implementation services
In addition to providing CDISC support within our software, SAS consultants are ready to help your organization implement CDISC standards to drive efficiencies in your clinical development processes.

Registered solution provider
SAS is recognized by CDISC as a CDISC Registered Solution Provider. Solution providers are qualified consultants, systems integrators and subject-matter experts believed by CDISC to have sufficient knowledge and experience implementing the various CDISC standards.