Proc CDISC

[deleted_user]

We just installed (Base) SAS v9.1.3 and I thought that included access to the Proc CDISC procedure. However I can't find any documentation. Can anyone help? Also, are there any other capabilities in v9 for CDISC that would be helpful?

[Dave_SAS]

Information about Proc CDISC can be found here: http://support.sas.com/rnd/base/xmlengine/proccdisc/index.html

SAS is planning to provide additional CDISC capabilities via the SAS Clinical Data Standards toolkit and the SAS Clinical Data Integration product in 2009. The toolkit is initially focused on SDTM validation and define.xml creation, and, like Proc CDISC, will be available at no additional cost over a SAS/Base license.

Dave
Business Solutions Manager for Life Sciences R&D, SAS

[deleted_user]

Hi Dave,

Thanks for your response.

I tried the proc with an AE SDTM File and got the following message: "Variable AESER is subject to controlled terminology but no format has been assigned"

Could you explain this message? I thought SDTM vars could not have a format assigned to them. In this case all the values were 'Y' or 'N' which I thought was acceptable.

[ODY7]

Hi deleted_user,
Are you able to share the code and data that you used for this? It is hard to tell why this could occur without looking. AESER should have character "Y" and "N" instead of values formatted to be "Y" or "M".

It is also worth noting that both SAS and SDTM has been updated since your Question. Although SAS PROC CDISC currently only supports (SDTMIG) version 3.1, with the latest version being 3.4, so some of PROC CDISC output when checking datasets for SDTM compliance is dated.

[kahulrolehs]

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@deleted_user wrote:
We just installed (Base) SAS v9.1.3 and I thought that included access to the Proc CDISC procedure. However I can't find any documentation. Can anyone help? Also, are there any other capabilities in v9 for CDISC that would be helpful?

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Base SAS v9.1.3 doesn’t natively include PROC CDISC; it’s part of the SAS Clinical Standards Toolkit, which may require additional licensing. For CDISC capabilities, check if you have access to SAS/Clinical Data Integration, as it offers tools for CDISC compliance and standards management.

[lowedirect]

Proc CDISC isn’t included with Base SAS v9.1.3 by default—it’s part of SAS Clinical Standards Toolkit, which is a separate component. If you don’t see it, it likely wasn’t installed. For CDISC support in v9, the toolkit helps with SDTM, ADaM, and define.xml generation, so it's worth checking if you can get it added.