Module 12 2019

Most basis “standard” - XML

XML = Extensible Markup Language

XML (v1.0) currently being used in the following ways: • Current uses • Labeling documents (SPL) • Data Definition Files (DDT) for CDISC SDTM and ADaM data • eCTD Backbones (M1 and M2-M5) • Future Uses • RPS bi-lateral communication (maybe someday) • Clinical protocols (ICH WG)

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The Organisation for Professionals in Regulatory Affairs