Working on and with CDISC Standards
Saturday, June 7, 2025
Adding Custom Rules to CDISC CORE - first experiences
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Today, I started gaining experience with the CDISC CORE feature that one can add its own "custom" core rules to the CORE engine...
Sunday, March 16, 2025
New PMDA rules for CDISC standards published March 2025
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PMDA (the Japanese regulatory authorities) have recently published new rules for use of CDISC standards. The Excel file with the rules c...
Saturday, November 25, 2023
The Need for Speed: Why CDISC Dataset-JSON is so important.
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The CDISC community has been suffering for 20 years or more by the obligation of FDA (and other regulatory authorities following FDA) to su...
Monday, January 9, 2023
CDISC SDTM codetables, Define-XML ValueLists and Biomedical Concepts
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Yesterday, I started an attempt to implement the " CDISC CodeTables " in software to allow even more automation when doing SDTM ...
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