CDISC standards

[Frank Furter]

Has anybody out there created and analyzed data sets with SPSS that conform to the CDISC data standards (http://www.cdisc.org)? Is there any SPSS syntax for this that could be shared?

As often, there is a whole support ppackage for CDISC for SAS, but not for SPSS ...

Thanks
Andreas

[David Marso]

Looking briefly at the site (please point to a specific document next time -really don't have time to click around and try to figure out what ) and looking over the standard definition really just browsed it very quickly I don't really see how SPSS syntax would apply in any direct way.  It sounds more like a standard for naming variables and mapping to definitions .  Maybe I'm missing the point.  Maybe a link to the SAS support docs to see what is up?

Andreas Voelp wrote

Has anybody out there created and analyzed data sets with SPSS that conform to the CDISC data standards (http://www.cdisc.org)? Is there any SPSS syntax for this that could be shared?

As often, there is a whole support ppackage for CDISC for SAS, but not for SPSS ...

Thanks
Andreas

[Frank Furter]

CDISC is a consortium dedicated to defining standards for capturing, managing, analyzing and exchanging data from clinical trials. The aim is to have uniform database structures, formats, and naming conventions observed by the industry, academic research, and regulatory authorities, which would make it much easier to exchange data and would also save lots of programming time during data analysis.

There are standards for data capturing, data management, and data analysis, which can be found under http://www.cdisc.org/standards. Metadata are defined in XML, see http://www.cdisc.org/stuff/contentmgr/files/0/919cb4ef843829170d470b37eb662aeb/misc/odm1_3_0_final.htm.

For SPSS users analyzing data from clinical trials it would be very helpful to have a library of data file definitions with variable and value labels, formats, etc., conforming to CDISC's Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). One of my motivations for posting was simply to see whether somebody might already have done this. Furthermore, it would also be great to have options in SPSS for reading and writing data in CDISC format.

SAS is a member of the CDISC consortium, and they offer a comprehensive toolkit for data analysis as well as a procedure for importing and exporting data in CDISC format (those are exactly the features that would be helpful to have in SPSS, too). For details, see http://www.sas.com/industry/life-sciences/cdisc/index.html, http://support.sas.com/rnd/base/cdisc/index.html, and http://support.sas.com/documentation/cdl/en/cdisc/60755/PDF/default/cdisc.pdf.