CDISC end-to-end

Maybe you will say: "Wait a minute Jozef, it is not allowed by the SDTM Standard to leave the supplemental qualifiers in the original d...

As already stated in my previous post, creating SDTM/SEND/ADaM datasets has a considerable number of advantages. Today I want to demonstrate...

The CDISC XML Technologies Team is currently working on an ODM-XML based format for SDTM, SEND and ADaM submissions (or exchange). This form...

One of the arguments that some at the FDA have for choosing HL7-v3-CDA as a future format for SDTM submissions is that CDA can carry electro...

There has been a lot of discussion about using HL7-v3 messages in XML for submissions to the FDA. Especially some people at the FDA (who are...

No that we made the define.xml more logical (and much more end-to-end-friendly), we can do the same for the data themselves. We do not need...

Although some people will protest, I am still stating that the SDTM standard has been written with SAS XPT in mind. The 8-character, 40-char...

The previous post showed a snippet of ODM-XML that could be used (and is used by a number of vendors) to store SDTM data in an XML format. ...

We do already submit the metadata of our SDTM submission in XML format (define.xml). So why not submit the SDTM/SEND/ADaM data themselves a...

Did you like the example from the previous post where metadata information from the study design is copied into (or imported into) the defin...