Sunday, May 29, 2005

 

CDISC and Last Day

On The last day of PharmaSUG, Wednesday, I saw a presentation by Thomas Cox from SAS Institute on CDISC standards. Thomas described how SAS is committed to data standards in that they are very involved in data standards organizations such as CDISC. They are also continuing to develop new tools to address these needs. Most of Thomas’s presentation used the ODM as an example, but he also touched upon the SDTM which is closer to what is used during submission. He suggests how there will be a transition from submitting SAS transport file in version 5, to the new standard DEFINE.XML. This is a “machine readable” format this is also going to replace the DEFINE.PDF. The DEFINE.XML on the surface looks like a PROC CONTENTS of the data. But as Thomas demonstrated with the new CDISC viewer, it has more information. The structure of the data is organized by clinical domains and follows standardization rules. PROC CDISC will review some of these rules and generates WARNING messages alerting you of potential non standards. There are also hyperlinks within the DEFINE.XML that allows you to drill down to code lists, and actual transport versions of your data if you want to see the contents.

Court Yard in Pheonix Arizona

The support for XML continues to be developed as SAS v9 XML engine is more robust. Besides the updated XML libname data engine, there are new formats and informats to help handle XML. The PROC CIDSC also will assist in generating the DEFINE.XML. Currently, the PROC CDISC does produce DEFINE.XML for the ODM model but the SDTM is not yet production. Here is an example as to how you use PROC CDISC:

PROC CDISC MODEL=SDTM;
SDTM SDTMversion=’3.1’;
DOMAINDATA data=conform.ae;
RUN:

It does not perform the data transformation but if your data is in the right format, it will convert it to the DEFINE.XML which can be viewed by the CDISC Viewer. One feature which I was impressed by with the CIDSC Viewer is that it has the ability to drill down to the audit history of how a particular variable is derived including the name of the programmer and text describing how they derived it. The CDISC Viewer allows you to drill down and see an audit log of all the pivotal points of the decisions for any particular dataset or variable. From a reviewer’s perspective, this metadata will be very informative during an audit. The challenge may be how you would capture and enter this information. Since the Sy/Validate tools automatically collect this audit history information, I thought it would be a great idea for it to feed this metadata directly into the DEFINE.XML. This will definitely be a good feature to be implemented soon. I also like the fact that he CDISC viewer can link to and view SAS datasets besides transport format. It will be a versatile multipurpose viewer.

This year’s conference was the “hottest” in record. It was also the most attended with 637 attendees. Next year will be held in Bonita Springs Florida where it was boasted as having milder weather since it is close to the beaches of the Gulf of Mexico. I hope to see you there next year.

Comments:
Nice information about CDISC. Its really very helpful for me. Awesome post....
 

Very Informative blog thank you for sharing. Keep sharing.

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