CDISC Study Data Tabulation Model (SDTM) Standard

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A CDISC Study Data Tabulation Model (SDTM) Standard is a CDISC Foundational Standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.



References

2022a

2022b

  1. Required by the FDA (U.S.) for new drug applications
  2. 2.0 2.1 2.2 Required by the FDA and PMDA (Japan) for new drug applications.

2022c

2022d

2018

  1. Standard for Exchange of Nonclinical Data (SEND) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/send.
  2. CDISC. CDISC Protocol Representation Model Version 1.0. http://cdisc.org/ CDISC. 2010.
  3. Analysis Data Model (ADaM) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/adam
  4. Clinical Data Acquisition Standards Harmonization (CDASH) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/cdash.
  5. Study Data Tabulation Model (SDTM) Clinical Data Interchange Standards Consortium. 2017. Available from: https://www.cdisc.org/standards/foundational/sdtm.

2017

2016

2016 CDISK-FS Fig1.jpg
Figure 1: ODM-based standards supporting the CDISC foundational standards content.