By Rebecca Kush, Frank Newby, David Iberson-Hurst, & Amanda J de Montjoie, CDISC
When rumors increase, and when there is an abundance of noise and clamor, believe the second report. Alexander Pope, 1688–1744
In recent weeks, there have been a number of rumors about the Clinical Data Interchange Standards Consortium CDISC standards and their continued use by the Food and Drug Administration (FDA). These whispers suggest that the Study Data Tabulation Model (SDTM) standard is being replaced and that the Operational Data Model (ODM) should no longer be used. The rumors have caused confusion at best and fear of standards abandonment at worst. This is a second report—an attempt to clarify what’s happened and how the industry should move forward.
CDISC, to state the obvious, is a global standards organization. While the FDA plays a vital role in the drug development industry in the U.S., there are other global stakeholders that use CDISC standards. CDISC’s influence extends as far east as Japan, Australia and China—and is well established in Europe.
An International Agenda
Just as biopharmaceutical communities are expanding globally, CDISC is being asked to meet with regulatory authorities in China and with academic representatives in Singapore, India and Brazil. CDISC has Liaison A status with the International Standards Organization Technical Committee 215 and works closely on global standards harmonization with CEN, ISO and HL7 as a member of the Joint Initiative Council.
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