CDISC

[1162]

I'll be working on a project where the client wants data in CDISC format. I read a bit of the SAS literature about importing and exporting in CDISC format, but I'm not sure I understand it fully.

Can any SAS dataset be exported in CDISC format or only files that were imported that way?

Is there anything special to pay attention to when exporting in this format?

Any help or references would be appreciated.

[Dave_SAS]

Any SAS data set can be exported in a CDISC format, but it tends to be more complex than that.

CDISC has a variety of different data models -- often, users want to convert data to the Submission Data Tabulation Model (SDTM) which requires restructuring the data to match the model (that is, call the dataset 'this', and the columns 'that'). Additonally, users sometimes need to use the Operational Data Model (ODM) as the transport mechanism or container.

The ODM file can contain SDTM data, but doesn't have to. Similarly, the SDTM can be transported via ODM, but can be a SAS data set or transport file.

This can be certainly be confusing, but without more information it's difficult to answer the question more directly.

Dave

[frisco]

I notice the latest guidance from the FDA on e-submission still lists version 5 transport files. Any idea on when they will be geared up to accept CDISC formatted XML files?