Clinical Data Acquisition Standards Harmonization (CDASH)

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A Clinical Data Acquisition Standards Harmonization (CDASH) is a CDISC Foundational Standard for collecting data consistently across clinical studies and sponsors.



References

2022a

The latest versions of the Clinical Data Acquisition Standards Harmonization Implementation Guides (CDASHIGs) have been developed in reference to a specific CDASH model. However, the CDASH model is cumulative – each new release builds on the previous model. Therefore, the models are considered backward compatible.

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

  • (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Clinical_Data_Interchange_Standards_Consortium#Overview_of_standards Retrieved:2022-2-25.
    • Dataset.XML (DataSet-XML)
      • Enables communication of study results as well as regulatory submission to FDA (pilot since 2014).
    • (...)
    • Clinical Data Acquisition Standards Harmonization (CDASH)
      • Defines a minimal data collection set for sixteen safety SDTM Domains, harmonizing element names, definitions and metadata. The objective is to establish a standardized data collection baseline across all submissions.
    • CDISC Terminology
      • Defines controlled terminology for SDTM and CDASH, provides extensible lists of controlled terms designed to harmonize data collected across submissions.

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.

2016

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