1、Information technology Metamodel framework for interoperability (MFI) Part 13: Metamodel for form design registration PD ISO/IEC TS 19763-13:2016 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of IS
2、O/IEC TS 19763- 13:2016. The UK participation in its preparation was entrusted to Technical Committee IST/40, Data management and interchange. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the neces
3、sary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 84056 2 ICS 35.040.50 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Docu
4、ment was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/IEC TS 19763-13:2016 Information technology Metamodel framework for interoperability (MFI) Part 13: M
5、etamodel for form design registration Technologies de linformation Cadre du mtamodle pour linteroprabilit (MFI) Partie 13: Mtamodle pour lenregistrement de la conception des formulaires ISO/IEC TS 19763-13 First edition 2016-12-01 Reference number ISO/IEC TS 19763-13:2016(E) TECHNICAL SPECIFICATION
6、ISO/IEC 2016 PD ISO/IEC TS 19763-13:2016 PD ISO/IEC TS 19763-13:2016 PUBLISHED DOCUMENTInformation technology Metamodel framework for interoperability (MFI) Part 13: Metamodel for form design registration Technologies de linformation Cadre du mtamodle pour linteroprabilit (MFI) Partie 13: Mtamodle p
7、our lenregistrement de la conception des formulaires ISO/IEC TS 19763-13 First edition 2016-12-01 Reference number ISO/IEC TS 19763-13:2016(E) TECHNICAL SPECIFICATION ISO/IEC 2016 PD ISO/IEC TS 19763-13:2016 ii ISO/IEC 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO/IEC 2016, Published in
8、Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
9、be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO/IEC TS 19763-13:2016(E) PD ISO/IEC/T
10、S 19763-13:2016ISO/IEC TS 19763-13:2016(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms, definitions and abbr e viat ed t erms 1 3.1 Terms and definitions . 1 3.2 Abbreviated terms . 3 4 Conformance . 3 4.1 General . 3 4.2 Degrees of conformance . 3 4.2.1 General 3 4.2.2 S
11、trictly conforming implementation 3 4.2.3 Conforming implementation . 4 4.2.4 Implementation Conformance Statement (ICS) 4 5 Structure of MFI form design registration . 4 5.1 Overview of MFI form design registration 4 5.2 Relationship of metaclasses to the MDR Metamodel . 7 5.3 Details provided in e
12、ach metaclass definition . 7 5.4 Basic Types and Enumerations in MFI form design registration 8 5.4.1 General 8 5.4.2 Property . 9 5.4.3 Question_Element_Property 9 5.4.4 Target_Element_State . 9 5.4.5 Operation_Type 10 5.5 Metaclasses in MFI for form design registration 11 5.5.1 Form_Design .11 5.5
13、.2 Form_Design_Language 11 5.5.3 Form_Design_Template .11 5.5.4 Form_Design_Element 11 5.5.5 Presentation_Element 12 5.5.6 Section_Element 13 5.5.7 Media_Element .14 5.5.8 Text_Element 14 5.5.9 Localised_Text .15 5.5.10 Question_Element 16 5.5.11 Response 17 5.5.12 Attachment 18 5.5.13 Text_Field.18
14、 5.5.14 Lookup_Field 18 5.5.15 List_Field 19 5.5.16 List_Item .20 5.5.17 List_Item_Selected_State 21 5.5.18 Rule .21 5.5.19 Constant22 5.5.20 Expression 22 5.5.21 Variable .23 5.5.22 Operation .23 5.5.23 Reference_Document 24 5.5.24 Datatype .24 5.5.25 Unit_Of_Measure .25 Annex A (normative) MDR Map
15、ping Package.26 Annex B (informative) Description of the metamodel .31 ISO/IEC 2016 All rights reserved iii Contents Page PD ISO/IEC TS 19763-13:2016 PD ISO/IEC TS 19763-13:2016 ISO/IEC TS 19763-13:2016(E) ii ISO/IEC 2016 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO/IEC 2016, Published in Sw
16、itzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be
17、 requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO/IEC TS 19763-13:2016(E) PD ISO/IEC/TS
18、19763-13:2016ISO/IEC TS 19763-13:2016(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms, definitions and abbr e viat ed t erms 1 3.1 Terms and definitions . 1 3.2 Abbreviated terms . 3 4 Conformance . 3 4.1 General . 3 4.2 Degrees of conformance . 3 4.2.1 General 3 4.2.2 Str
19、ictly conforming implementation 3 4.2.3 Conforming implementation . 4 4.2.4 Implementation Conformance Statement (ICS) 4 5 Structure of MFI form design registration . 4 5.1 Overview of MFI form design registration 4 5.2 Relationship of metaclasses to the MDR Metamodel . 7 5.3 Details provided in eac
20、h metaclass definition . 7 5.4 Basic Types and Enumerations in MFI form design registration 8 5.4.1 General 8 5.4.2 Property . 9 5.4.3 Question_Element_Property 9 5.4.4 Target_Element_State . 9 5.4.5 Operation_Type 10 5.5 Metaclasses in MFI for form design registration 11 5.5.1 Form_Design .11 5.5.2
21、 Form_Design_Language 11 5.5.3 Form_Design_Template .11 5.5.4 Form_Design_Element 11 5.5.5 Presentation_Element 12 5.5.6 Section_Element 13 5.5.7 Media_Element .14 5.5.8 Text_Element 14 5.5.9 Localised_Text .15 5.5.10 Question_Element 16 5.5.11 Response 17 5.5.12 Attachment 18 5.5.13 Text_Field.18 5
22、.5.14 Lookup_Field 18 5.5.15 List_Field 19 5.5.16 List_Item .20 5.5.17 List_Item_Selected_State 21 5.5.18 Rule .21 5.5.19 Constant22 5.5.20 Expression 22 5.5.21 Variable .23 5.5.22 Operation .23 5.5.23 Reference_Document 24 5.5.24 Datatype .24 5.5.25 Unit_Of_Measure .25 Annex A (normative) MDR Mappi
23、ng Package.26 Annex B (informative) Description of the metamodel .31 ISO/IEC 2016 All rights reserved iii Contents Page PD ISO/IEC TS 19763-13:2016 PD ISO/IEC TS 19763-13:2016 ISO/IEC TS 19763-13:2016(E) ISO/IEC TS 19763-13:2016(E)Annex C (informative) Relationship of metaclasses to the MDR Metamode
24、l 37 Annex D (informative) Example form designs .40 Annex E (informative) Mapping between this document and CDISC ODM .44 Bibliography .47 iv ISO/IEC 2016 All rights reserved PD ISO/IEC/TS 19763-13:2016ISO/IEC TS 19763-13:2016(E) Foreword ISO (the International Organization for Standardization) and
25、IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. National bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with
26、 particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest. Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of information technology, ISO and IEC have
27、 established a joint technical committee, ISO/IEC JTC 1. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should b
28、e noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identi
29、fying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenie
30、nce of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see th
31、e following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/IEC JTC 1, Information Technology, Subcommittee SC 32, Data management and interchange. A list of all parts in the ISO/IEC 19763 series can be found on the ISO website. ISO/IEC 2016 All rights reserved
32、 v PD ISO/IEC/TS 19763-13:2016 PD ISO/IEC TS 19763-13:2016 ISO/IEC TS 19763-13:2016(E) ISO/IEC TS 19763-13:2016(E)Annex C (informative) Relationship of metaclasses to the MDR Metamodel 37 Annex D (informative) Example form designs .40 Annex E (informative) Mapping between this document and CDISC ODM
33、 .44 Bibliography .47 iv ISO/IEC 2016 All rights reserved PD ISO/IEC/TS 19763-13:2016ISO/IEC TS 19763-13:2016(E) Foreword ISO (the International Organization for Standardization) and IEC (the International Electrotechnical Commission) form the specialized system for worldwide standardization. Nation
34、al bodies that are members of ISO or IEC participate in the development of International Standards through technical committees established by the respective organization to deal with particular fields of technical activity. ISO and IEC technical committees collaborate in fields of mutual interest.
35、Other international organizations, governmental and non-governmental, in liaison with ISO and IEC, also take part in the work. In the field of information technology, ISO and IEC have established a joint technical committee, ISO/IEC JTC 1. The procedures used to develop this document and those inten
36、ded for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.
37、iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document w
38、ill be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expr
39、essions related to conformit y assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. The committee responsible for this document is ISO/IEC JTC 1, Informa
40、tion Technology, Subcommittee SC 32, Data management and interchange. A list of all parts in the ISO/IEC 19763 series can be found on the ISO website. ISO/IEC 2016 All rights reserved v PD ISO/IEC/TS 19763-13:2016 PD ISO/IEC TS 19763-13:2016 ISO/IEC TS 19763-13:2016(E) ISO/IEC TS 19763-13:2016(E) In
41、troduction There is an increasing demand for systems to interoperate by exchanging data, and for data to be reused outside of the original context of its collection. For data exchange or reuses to be meaningful, the business information requirements that are met by the data stored in these systems m
42、ust be understood so that suitable data exchange mechanisms can be developed and interpretation of the data is reliable. Not only does this require a clear understanding of the meaning of the data, it also frequently requires the coordination of data capture. Where data input is manual, the definiti
43、ve source of data semantics is the design of the data entry form. Indeed if we do not understand the encoding of knowledge in the database schema or we suspect some anomaly in the data captured, we inspect the original form and the context of its use. Furthermore, if we wish to gather interoperable
44、data, it is frequently necessary to harmonize aspects of form design before information systems are developed and data is captured. However, there is no abstract, universal metamodel for form designs that supports the registration and comparison or harmonization of form designs and faithful implemen
45、tation of these designs in information systems. This is the intent of this document. The Oxford English dictionary defines a form as “a formulary document with blanks for the insertion of particulars”. Other ISO definitions of a form include ISO 5127, “document (printed or otherwise produced), with
46、pre-designated spaces for the recording of specific information”, and ISO 9241-143, “structured display of fields and other user-interface elements that the user reads, fills in, selects entries for (e.g. through check boxes or radio buttons) or modifies”. While we recognize these definitions, none
47、precisely matches the needs of this document. Thus, we will define a form as a structured collection of spaces, suitable instructions and rules that support the collection of specific information that may be subsequently compared and processed in a routine fashion. A form design is thus a descriptio
48、n of a particular form such that it may be rendered in any suitable information system, and the metamodel for registration of form designs contained within this document describes the attributes that are necessary to represent the semantics and syntax of form designs. Given a standard metamodel for
49、the registration of form designs, ISO/IEC 19763 Metamodel framework for interoperability (MFI) and ISO/IEC 11179 Metamodel for metadata registries provide important facilities for the creation and annotation of form designs. ISO/IEC 19763 supports the registration of form designs and section elements as models and model elements, provides facilities to record associations between the components of two or more form design, particularly derivation, specialization, extension and reuse, and allows the associ
