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Agenda (copy of slides CDISC_IT_TC_20181128.pptx)

  • CDISC and Data Submission What’s New

  • CDISC and Data Submission topics from PhUSE 2019

  • CDISC and Machine Learning. “State of the Art” from CDISC EU Interchange and PhUSE 2019

  • How to handle ‘Multiple Enrolment’ and ‘Multiple screen Failure’ in SDTM e.g. USUBJID. “State of the Art” from CDISC, PhUSE Working Group and  FDA Guidance

  • Other Topics

Attached slides and Note about FDA Study Data Technical Conformance Guidance FDA_TCG_Memo.pdf

Unofficial PDF version of SDTM Ig 3.3, BIMO and WHO-DD B3 guidance can be found here Unofficial CDISC and Data Standards Related Documents Repository


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