CAN/CSA-ISO/IEC TS 19763-13:18 (R2022)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviated terms
4 Conformance
5 Structure of MFI form design registration
Annex A (normative) - MDR Mapping Package
Annex B (informative) - Description of the metamodel
Annex C (informative) - Relationship of metaclasses to the
        MDR Metamodel
Annex D (informative) - Example form designs
Annex E (informative) - Mapping between this document and
        CDISC ODM
Bibliography

Preface Standards development within the Information Technology sector is harmonized with international standards development. Through the CSA Technical Committee on Information Technology (TCIT), Canadians serve as the SCC Mirror Committee (SMC) on ISO/IEC Joint Technical Committee 1 on Information Technology (ISO/IEC JTC1) for the Standards Council of Canada (SCC), the ISO member body for Canada and sponsor of the Canadian National Committee of the IEC. Also, as a member of the International Telecommunication Union (ITU), Canada participates in the International Telegraph and Telephone Consultative Committee (ITU-T). Scope The primary purpose of the ISO/IEC 19763 series is to specify a metamodel framework for interoperability. This document specifies a metamodel for registering form designs. This document provides a metamodel to describe the structure and semantics of an implemented form devoid of any specific, domain semantics, e.g. in healthcare, social science, e-government and e-business, or representation format so that data may be faithfully exchanged between systems and system components, and associations expressed between sets of form designs whose data may be compared, joined or composed for analysis.

CSA Preface Standards development within the Information Technology sector is harmonized with international standards development. Through the CSA Technical Committee on Information Technology (TCIT), Canadians serve as the SCC Mirror Committee (SMC) on ISO/IEC Joint Technical Committee 1 on Information Technology (ISO/IEC JTC1) for the Standards Council of Canada (SCC), the ISO member body for Canada and sponsor of the Canadian National Committee of the IEC. Also, as a member of the International Telecommunication Union (ITU), Canada participates in the International Telegraph and Telephone Consultative Committee (ITU-T). For brevity, this Standard will be referred to as “CAN/CSA-ISO/IEC TS 19763-13” throughout. At the time of publication, ISO/IEC TS 19763-13:2016 is available from ISO and IEC in English only. CSA Group will publish the French version when it becomes available from ISO and IEC. The ISO/IEC Technical Specification was reviewed by the CSA TCIT under the jurisdiction of the CSA Strategic Steering Committee on Information and Communications Technology and deemed acceptable for use in Canada. From time to time, ISO/IEC may publish addenda, corrigenda, etc. The TCIT will review these documents for approval and publication. For a listing, refer to the Current Standards Activities page at standardsactivities.csa.ca. This Standard has been formally approved, without modification, by the Technical Committee and has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope The primary purpose of the ISO/IEC 19763 series is to specify a metamodel framework for interoperability. This document specifies a metamodel for registering form designs. This document provides a metamodel to describe the structure and semantics of an implemented form devoid of any specific, domain semantics, e.g. in healthcare, social science, e-government and e-business, or representation format so that data may be faithfully exchanged between systems and system components, and associations expressed between sets of form designs whose data may be compared, joined or composed for analysis.