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CDISC Members Only Mini-Training Series - Define-XML v2.0 Completion Guidelines and Style Sheet Recommendations
Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the regulatory authorities what datasets, variables, controlled terms, and other specified metadata were used.
Define-XML is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page
Date and Time
THU, 28 SEP 2017
10:00 AM - 11:30 AM CDT
- Marcelina Hungria, CDISC/SAS, Data Submission Consulting Services, Dlcore Group, LLC
- Dmitry Kolosov, Principal Statistical Programmer, PAREXEL
- Lex Jansen, Principal Software Developer, SAS Institute Inc.
- Prafulla Girase, Principal Analyst, Biogen Idec
- Sally Cassells, Owner, Next Step Clinical Systems LLC
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Please register for this members only webinar using your organizational e-mail address. If you aren't sure whether your organization is a CDISC Member, please review the member list here and confirm before you register.