Training Description:
Master Define-XML essentials with our comprehensive training! Discover the critical role of Define-XML in CDISC data submissions to FDA, PMDA and other regulatory agencies. From understanding XML fundamentals to accurately representing metadata for SDTM and ADaM datasets, variables, associated value-level metadata, and codelists, plus the use of the CDISC Library, this training equips you with essential skills. Learn how to manage challenges in Define-XML implementation and gain insights into Analysis Results Metadata. By the end of the day, you'll be proficient in generating Define-XML documents and navigating its relationship with ODM and other CDISC Data Exchange standards, including the new Dataset-JSON standard. Join us to elevate your expertise and ensure seamless regulatory compliance!
Register today for trainings at this discounted introductory price!
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Language: This training will be taught half in Korean and half in English (with Korean translation); training materials are in English.
Lead Instructor: Monika Kawohl (English speaker)
Co-Instructor: YoungJae Lee (native Korean speaker)
