CDISC Study Data Tabulation Model (SDTM) Standard

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.

• Context:
  • It is available at: https://www.cdisc.org/standards/foundational/sdtm
  • It includes an Study Data Tabulation Model Implementation Guide (SDTMIG) to guide the organization, structure, and format of standard clinical trial tabulation datasets.
  • It is a required standard for data submission to FDA (U.S.) and PMDA (Japan).
  • ...
• Example(s):
  • SDTM v2.0 (2021-11-29).
  • SDTM v1.8 (2019-09-17),
  • SDTM v1.7,
  • SDTM v1.6,
  • SDTM v1.5,
  • SDTM v1.4,
  • ...
  • …
• Counter-Example(s):
  • CDISC-ADaM.
  • CDISC-PRM.
  • CDISC-CDASH.
  • CDISC-SEND.
  • CDISC TA.
• See: CDISC Semantics Standard, Clinical Data Interchange Standards Consortium (CDISC) RWD Connect Initiative, Standard-Developing Organization, Clinical Trial Data, Clinical Data Standards, CDISC Shared Health And Research Electronic library (SHARE), CDISC Operational Data Model (ODM), CDISC BRIDG Model. CDISC SHARE Application Programming Interface (API), CDISC SHARE Software Ecosystem.

---

---

References

2022a

• (CDISC, 2022) ⇒ https://www.cdisc.org/standards/foundational Retrieved:2022-2-27.
  • QUOTE: SDTM provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting. Implementing SDTM supports data aggregation and warehousing; fosters mining and reuse; facilitates sharing; helps perform due diligence and other important data review activities; and improves the regulatory review and approval process. SDTM is also used in non-clinical data (SEND), medical devices and pharmacogenomics/genetics studies.

    SDTM 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

• (CDISC, 2022) ⇒ https://www.cdisc.org/standards/foundational Retrieved:2022-2-25.
  • QUOTE:
    • CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.
    • Protocol Representation Model (PRM) provides a standard for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria, and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries, and EudraCT registries. PRM assists in automating CRF creation and EHR configuration to support clinical research and data sharing.
    • Standard for Exchange of Nonclinical Data (SEND) is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format.
    • Clinical Data Acquisition Standards Harmonization (CDASH) establishes a standard way to collect data in a similar way across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.
    • Study Data Tabulation Model (SDTM) provides a standard for organizing and formatting data to streamline processes in collection, management, analysis and reporting.
    • Study Data Tabulation Model Implementation Guide (SDTMIG) is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets.
    • Analysis Data Model (ADaM) defines dataset and metadata standards that support:
      • (...)

2022c

• (Facile et al., 2022) ⇒ Rhonda Facile, Erin Elizabeth Muhlbradt, Mengchun Gong, Qingna Li, Vaishali Popat, Frank Petavy, Ronald Cornet, Yaoping Ruan, Daisuke Koide, Toshiki I. Saito, Sam Hume, Frank Rockhold, Wenjun Bao, Sue Dubman, Barbara Jauregui Wurst (2022). "Use of Clinical Data Interchange Standards Consortium (CDISC) Standards for Real-world Data: Expert Perspectives From a Qualitative Delphi Survey". In: JMIR medical informatics, 10(1), e30363.
  • QUOTE: The CDISC standards span the clinical research process and include standards for the exchange of nonclinical data (SEND), data collection case report forms (CRFs; clinical data acquisition standards harmonization (CDASH)), aggregation and tabulation (study data tabulation model (SDTM)), Biomedical Research Integrated Domain Group (BRIDG) logical model, and operational data model (ODM) for transport (Figure 1). In collaboration with the National Cancer Institute's Enterprise Vocabulary Services (NCI-EVS) program, CDISC has developed a rich controlled terminology that is linked to other common research semantics through the NCI-EVS tools. These standards, presented in data models, implementation guides, and user guides, are globally recognized and heavily used by the biopharmaceutical industry and some academic institutions.

Figure 1: Clinical Data Interchange Standards Consortium standards in the clinical research process. ADaM: Analysis Data Model; BRIDG: Biomedical Research Integrated Domain Group; CDASH: clinical data acquisition standards harmonization; ODM: operational data model; PRM: Protocol Representation Model; SDM: Study Design Model; SDTM: study data tabulation model.

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.
  • ...

2018

• (Hume et al., 2018) ⇒ Samuel Hume, Anthony Chow, Julie Evans, Frederik Malfait, Julie Chason, J. Darcy Wold, Wayne Kubick,and Lauren B. Becnel (2018). "CDISC SHARE, a Global, Cloud-based Resource of Machine-Readable CDISC Standards for Clinical and Translational Research". In: AMIA Summits on Translational Science Proceedings, 2018, 94.
  • QUOTE: CDISC standards (Figure 1) are categorized as Foundational Standards, Semantics, Therapeutic Area (TA) Standards, and Transport Standards. Foundational Standards include Standard for Exchange of Nonclinical Data (SEND) for the collection and tabulation of animal model and other pre-clinical data, Protocol Representation Model (PRM), Analysis Data Model (ADaM) for defining analysis datasets, Clinical Data Acquisition Standards Harmonization (CDASH) that provide a minimal set of data elements common to essentially all studies, the Study Data Tabulation Model (SDTM) for data tabulation, and others.

Figure 1: CDISC End-to-end Standards including Foundational Standards, Semantics, and TA Standards.

2016

• (Hume et al., 2016) ⇒ Sam Hume, Jozef Aerts, Surendra Sarnikar, and Vojtech Huserc (2016)."Current Applications and Future Directions for the CDISC Operational Data Model Standard: A Methodological Review". In: Journal of biomedical informatics, 60:352-362. DOI:10.1016/j.jbi.2016.02.016
  • QUOTE: Figure 1 highlights the CDISC foundational standards covered by ODM, and standardized extensions such as Clinical Data Acquisition Standards Harmonization (CDASH) that describes the basic data collection fields for domains, the Study Data Tabulation Model (SDTM) that describes a standard structure for study data tabulations, and the Analysis Data Model (ADaM) that describes metadata models and examples for analysis datasets (...)

Figure 1: ODM-based standards supporting the CDISC foundational standards content.

---