" /> Interoperability - CISMeF





Preferred Label : Interoperability;

Définition CISMeF : Ability to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks in various settings, and exchange data such that clinical or operational purpose and meaning of the data are preserved and unaltered.; Source: From U.S. Food and Drug Administration. (2024). Study Data Technical Conformance Guide- Technical Specifications Document. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document (This Technical Specifications Document is incorporated by reference into the Guidance for Industry Providing Regulatory Submissions in Electronic Format – Standardized Study Data. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data);

NCIt definition : The capability of two or more systems or components to use and transfer information reciprocally.;

Alternative definition : CDISC-GLOSS: Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability.;

NCI Metathesaurus CUI : CL540329;

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Ability to communicate and exchange data accurately, effectively, securely, and consistently with different information technology systems, software applications, and networks in various settings, and exchange data such that clinical or operational purpose and meaning of the data are preserved and unaltered.
Source: From U.S. Food and Drug Administration. (2024). Study Data Technical Conformance Guide- Technical Specifications Document. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document (This Technical Specifications Document is incorporated by reference into the Guidance for Industry Providing Regulatory Submissions in Electronic Format – Standardized Study Data. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data)

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30/07/2025


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