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Why do a 3rd of Submissions fail the Technical Rejection Criteria?

Clinical Programming Team

At the July 25th PhUSE Webinar Wednesday, Ethan Chen (Director, Division of Data Management Services and Solutions Office of Business Informatics, FDA CDER) gave us a glimpse of the FDA’s view on Technical Rejection Criteria for Study Data. Those that were at the US Connect Conference earlier in the year may have seen this already.

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Topics: Define.xml, ADaM Datasets, CDISC Standards, SDTM, SAS Programming, FDA, CDISC, SDTM Domains, CDISC SDTM, CDISC Guidelines

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