Clinical Data Interchange Standards Consortium (CDISC) Foundational Standard

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A Clinical Data Interchange Standards Consortium (CDISC) Foundational Standard is a CDISC Standard that is focused on defining standards for preclinical/clinical trial data and includes models, domains and specifications for data representation.



References

2022a

  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.

2022b

2022c

  • (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).
    • Operational Data Model (ODM).
      • The highlights of ODM: includes audit trail, utilizes XML technology, machine- and human- readable, all information are independent from databases, storing of ODM is independent from hard- and software.
    • Laboratory Data Model (LAB)
      • The Lab standard is used for exchange of laboratory data between labs and CROs
    • Case Report Tabulation Data Definition Specification (CRT-DDS)
      • Also referred to as “define.xml", a machine readable version of the regulatory submission "define.pdf".
    • 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

Except for Protocol, the foundational standards and their implementation guides are organized into classes of related categories of information. Within SDTM for example, each class is subdivided into domains, and each domain is comprised of variables. Semantics include CDISC Controlled Terminologies, developed in collaboration with NCI EVS, and the Biomedical Research Integrated Domains Group (BRIDG) domain information model. TA User Guides provide indication-specific “slices” of foundational standards and their terminologies, with examples of how to use these standards for a given TA. Transport Standards support submissions, data interchange, study archival, and automated study setup[6].
  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.
  6. Hume S, Aerts J, Sarnikar S, Huser V. Current applications and future directions for the CDISC Operational Data Model standard: A methodological review. Journal of Biomedical Informatics. 2016

2017

2016

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