OpenCDISC community 2.0

Creation of define,xml

As one of the developers of the define.xml standard I can give you some background information.
The SAS files that you create contain only a minimal amount of metadata. So yes, you really need to provide additional information through the worksheet (in the case of OpenCDISC). The define.xml file contains a high amount of metadata (data about the data) that the reviewers need to have to be able to work with your data sets. This information (not present in the SAS files) include data types, codelists, formatting information, valuelist-level information, information about the origin of the data, the title of the study, the protocol, etc..

Even a great tool like OpenCDISC cannot create such information out of the vacuum! Someone needs to provide it, and that's you: the user.

Even better would be if you create your define.xml BEFORE you even start generating the SDTM files. Essentially, the define.xml is or should be the creation specification for your datasets. Already many sponsors nowadays provide a define.xml to their service providers, containing the information/specification of what must later come into the SDTM files. Or with other words: the define.xml drives the mapping between your operational data and the submission data.

I can highly recommend the paper of Mark Wheeldon and Kevin Burges (also one of the developers of the define.xml standard) which you can find at: http://www.lexjansen.com/pharmasug/2014/DS/PharmaSUG-2014-DS01.pdf.
Read it - and you will enter new world ...  :-)

OpenCDISC

Thanks XML4pharma for the information provided. But, my questions were specifically related to community2.0 like what happens if we dont provide the complete infromation, I know the define.xml is not complete until we have all the information, but was curious to know what happens when we dont provide. But looks like we can produce define with the missing information (like labels, codes etc). 

Thanks again for link to the paper.

Define.xml Generation

Hi,

Yes we designed the Define.xml generator so you have the option to generate a limited Define.xml during study planning or while your study is in progress.  This is one reason why the Excel spec is useful, letting you add information later so you can re-generate a more robust Define.xml as you have more information.  It will just be incomplete until you add origins, methods, comments, etc...  You can use this Define.xml to share with your external partners or CRO's so you agree on what data will be collected and how you want the data collected.

Be sure to validate it once it is complete at the end of the study so it is ready for submission.

thanks , Travis