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Evolving CDISC Standards and Technologies
Session Chair(s)
Rhonda Facile, MS
Vice President, Partnerships and Development, CDISC, United States
This session will include the latest updates on CDISC standards with examples and annotated case report forms or survey instruments to improve semantic understanding, support data sharing, and facilitate global regulatory submission.
Learning Objective : Discuss the PDUFA VI and how this regulation relates to the use of data standards; Identify how CDISC is responding to PDUFA VI; Explain how FDA is preparing for the upcoming mandate to use LOINC; Describe the therapeutic area standards program and the role of global regulatory authorities in their development and endorsement.
Speaker(s)
Kit Howard, MS
Senior Director, Standards Development & Education, CDISC, United States
CDASH and SDTM: Why You Need Both
Bess LeRoy, MPH
Head of Standards Development, CDISC, United States
SHARE Metadata Repository
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