One comment on “Standards in Style: The CDISC EU Interchange

  1. Congratulations to the E3C committee for a wildly successful meeting!
    I also found some interesting themes throughout the meeting, although different than what you reported here. They are:
    CDISC SDTM Submission Content – there was a lot of talk about what the reviewers want to see and how they want to see it. I found it interesting that this varied by reviewer, and is definitely not a one-size-fits-all type answer. A significant piece of knowledge I left with was details for reviewing the FDA Checklist used for SDTM submissions. This checklist appears to be common sense type items, but is valuable nonetheless, particularly in the study planning process.
    CDISC and EHR Integration – There is typically buzz at the conference around the integration standards with the electronic health record world, but the most interesting information I heard was that only 13.4% of the data collected in a EHR is used in clinical research. I suspected the number was this small, and I know am not going to worry too much about this integration knowing that the complexity around this data integration process currently outweighs the value of retrieving this potentially messy small amount of data. I will also continue to monitor EHR4CR to see how they progress.
    Lastly, I learned what English Sponge Cake looks like.

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