CDISC Analysis Data Model (CDISC-ADaM)

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A Analysis Data Model (ADaM) is a CDISC Foundational Standard that defines dataset and metadata standards that support a clinical trial statistical analysis and traceability.



References

2022a

ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).

Details on the requirements for FDA are specified in the FDA's Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.

Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.

2022b

  1. 1.0 1.1 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).
    • Study Data Tabulation Model (SDTM)
      • Recommended for FDA regulatory submissions since 2004.
      • The SDTM Implementation Guide (SDTM-IG) gives a standardized, predefined collection of domains for clinical data submission, each of which is based on the structure and metadata defined by the SDTM.
    • Standard for Exchange of Non-clinical Data (SEND).
      • The SEND Implementation Guide (SEND-IG) provides predefined domains and examples of non-clinical (animal) data based on the structure and metadata defined by the SDTM.
    • Analysis Data Model (ADaM)
      • Defines dataset and metadata standards that support statistical analyses and traceability. ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
    • (...)

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.