Agenda:
- This webinar will address a topic related to Define-XML and ODM-XML.
- 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 FDA what datasets, variables, controlled terms, and other specified metadata were used.
- ODM-XML is a vendor-neutral, platform-independent format for exchanging and archiving clinical study data.
Panelist(s):
- Jozef Aerts, CEO, XML4Pharma