5 comments on “CDISC Standards: Assessing the Impact of Change

  1. Excellent Dave, sorry I missed your presentation today.

    Great quotes: “We need to be far more aware of versions and the relationship between various versions” And, of course :-), “But whatever the model, the semantic web helps us expand and adjust as we learn.”.

    Quick comment: you point to CDISC2RDF : “semantic definitions of the SDTM using the CDISC2RDF project outputs”. I think you are referring to the output from the PhUSE Semantic Technology project: https://github.com/phuse-org/rdf.cdisc.org CDISC2RDF was the name on the early work we did to show case the opportunities with RDF back in 2012, while all the hard work was done by Frederik Malfait, Geoff Low et al in the PhUSE project.

      1. Yes, CDISC2RDF is nice name and it’s a pitty PhUSE didn’t use it. I know Mitra Rocca linked it and also talkes about MedDRA2RDF.

  2. As each year again, it was a great pleasure to have you as a presenter again! Fresh ideas and demonstrating new tools that help us doing integration things that were classically done (or could not done at all) using worksheets.
    Do you think that the things you demonstrated can also help us to come to a machine-executable (but still human editable/readable) protocol. Would it be possible for protocol writers to “drag-and-drop” research concepts into their protocols and add text to it?
    Today, I just read (being late) through the “FDA/NIH protocol template”. My first impression is that the combination of SDM-XML, CTR-XML, ODM and CDISC-CT covers 80-90% of it, but there is even no mention of CDISC at all. Would bringing everything together (including the research concepts) allow us to finally come to the machine-executable protocol that looks to the “paper” protocol for the human user?

    1. Jozef

      Good to see you in Vienna.

      I believe the answer to your question is yes. They can help. What we write in protocols tend to be Biomedical (Research) Concepts names. We refer to observations or known sets of them.

      I also feel it is worth investigating whether or not they offer better ways to express a protocol in a machine readable form moving away from the traditional ‘schedule of assessments’ grid; more of a subject timeline approach but allowing us to generate a SoA view of we need it.

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