December 2010 – The FDA have made an announcement on their preference towards SDTM.  It is not as firm as I would have like to have seen.   They met up with representatives from CDISC. The CDISC organization wrote down some notes on the discussion, and posted them to their Blog.

Question –  why does this message need to come out by proxy from CDISC?  Why can the FDA CDER / CBER not step off the fence and make a firm statement on what they want, and when they want it?

One point made was that applying CDASH is the key to attaining SDTM datasets.  Well.  Sort of.  It is a good start point. But, it is only a start point.

The CDASH forms are very closely modeled on the structure of SDTM domains.   Do I always want to capture one domain, on one eCRF form – not always.  Do I want to sometimes capture information that is logically grouped together according to source documents that belongs to multiple domains on the same eCRF – often I do.  We should not compromise the user friendliness and therefore compliance at the sites because of a need to capture data according to the structure of the data extracts.

CDASH was developed around the principle that the EDC or CDM system modeled eCRF’s to equal SDTM domains.   If your EDC or CDM system does not do that, then compliance with CDASH is not entirely valuable.

However – or rather HOWEVER – if you fail to apply equivalent naming conventions to CDASH/SDTM and fail to use matching Controlled Terminology, and, you expect to achieve SDTM – you will be severely disappointed. Achieving SDTM will not be hard – it will be virtually impossible.

With regards to the statement that applying CDASH can create 70-90% savings.  That is not the whole story.  Apply CDASH + standardizing all of the other elements such as rules, visits etc – and automating testing and documentation – yes, then you can achieve a 70-90% savings.

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