Clinical Data Interchange Standards Consortium Controlled Terminology (CDISC-CT) and Semantics Standard

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A Clinical Data Interchange Standards Consortium Controlled Terminology (CDISC-CT) and Semantics Standard is a CDISC Standard that is a set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets.

AKA: CDISC Controlled-Terminology Standard, CDISC Semantics Standard.
Context:
- It was developed in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS) and Biomedical Research Integrated Domains Group (BRIDG).
- It supports the controlled terminology needs of CDISC Foundational and Therapeutic Area Standards.
- …
Example(s):
- CDISC Protocol Terminology;
- CDISC Define-XML Terminology;
- CDISC Glossary,
- …
Counter-Example(s):
See: 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/terminology Retrieved:2022-2-25.
- QUOTE: CDISC Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within the Foundational Standards and Therapeutic Area User Guides. CDISC Terminology provides context, content, and meaning to clinical research data and provides a consistent semantic layer across all operational contexts, enabling interoperability of the CDISC Standards. Each of the Foundational Standards' data models includes terminology implementation requirements.
  CDISC Terminology is published by the US National Cancer Institute’s Enterprise Vocabulary Services (NCI-EVS) as a set of terminology products that support the use of and harmonization among the CDISC Foundational Standards. These products include Protocol, SEND, CDASH, SDTM, ADaM, Define-XML, and Glossary. CDISC Terminology consists of submission values, definitions, synonyms, codelists, codes, and code system elements, which are needed to specify a complete terminology system.

2022b

(CDISC, 2022) ⇒ https://www.cdisc.org/standards/terminology/controlled-terminology Retrieved:2022-2-25.
- QUOTE: Controlled Terminology is the set of codelists and valid values used with data items within CDISC-defined datasets. Controlled Terminology provides the values required for submission to FDA and PMDA in CDISC-compliant datasets. Controlled Terminology does not tell you WHAT to collect; it tells you IF you collected a particular data item, how you should submit it in your electronic dataset.
  CDISC, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the Controlled Terminology needs of CDISC Foundational and Therapeutic Area Standards.

2022c

(NIH, 2022) ⇒ https://datascience.cancer.gov/resources/cancer-vocabulary/cdisc-terminology Retrieved:2022-2-25.
- QUOTE: The Clinical Data Interchange Standards Consortium (CDISC) is an open, non-profit organization that develops and supports global data standards to improve the quality and interoperability of medical research and healthcare. CDISC standards are widely used for study planning and data collection, tabulation, analysis, and submissions to the U.S. Food and Drug Administration (FDA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory agencies internationally.
  CDISC partners with NCI Enterprise Vocabulary Services (EVS) to develop and support controlled terminology for all CDISC foundational standards (Protocol, CDASH, SDTM, SEND, ADaM, Define-XML, and CDISC Glossary) and CDISC Therapeutic Area Standards. CDISC Terminology goes through an extensive process of content development and public review, with wide participation from the research and healthcare community. EVS maintains and distributes CDISC Controlled Terminology as part of NCI Thesaurus (NCIt).
  CDISC Terminology is freely available, without licensing restrictions, and versioned by date; all previous versions can be found in the archive subdirectories.

2022d

(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).
- 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.

2022e

(Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Clinical_Data_Interchange_Standards_Consortium#Overview_of_standards Retrieved:2022-2-25.
- (...)
- CDISC Terminology
  - Defines controlled terminology for SDTM and CDASH, provides extensible lists of controlled terms designed to harmonize data collected across submissions.

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 (...)

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

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^[1].

↑ 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

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