ISO/IEC TS 19763-13:2016
(Main)Information technology — Metamodel framework for interoperability (MFI) — Part 13: Metamodel for form design registration
Information technology — Metamodel framework for interoperability (MFI) — Part 13: Metamodel for form design registration
The primary purpose of the ISO/IEC 19763 series is to specify a metamodel framework for interoperability. ISO/IEC TS 19763-13(E) specifies a metamodel for registering form designs. ISO/IEC TS 19763-13(E) 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.
Technologies de l'information — Cadre du métamodèle pour l'interopérabilité (MFI) — Partie 13: Métamodèle pour l'enregistrement de la conception des formulaires
General Information
Standards Content (Sample)
TECHNICAL ISO/IEC TS
SPECIFICATION 19763-13
First edition
2016-12-01
Information technology —
Metamodel framework for
interoperability (MFI) —
Part 13:
Metamodel for form design
registration
Technologies de l’information — Cadre du métamodèle pour
l’interopérabilité (MFI) —
Partie 13: Métamodèle pour l’enregistrement de la conception des
formulaires
Reference number
ISO/IEC TS 19763-13:2016(E)
©
ISO/IEC 2016
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ISO/IEC TS 19763-13:2016(E)
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ISO/IEC TS 19763-13:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 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 Strictly 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 each 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 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
5.5.14 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 Constant.22
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 Mapping Package.26
Annex B (informative) Description of the metamodel .31
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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 .44
Bibliography .47
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ISO/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. 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 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 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 be 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 identifying 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 convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment,
as well as information about ISO’s 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, 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.
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ISO/IEC TS 19763-13:2016(E)
Introduction
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 must 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 definitive 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 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 implementation 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 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
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 description 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 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 association of form designs with the data models
that are used to store data captured by their instances. ISO/IEC 11179 provides classes and types that
support the identification, naming, registration and administration of form designs and supporting
documents, and provides a model either for an associated, standardized question bank or a rich source
of question-level metadata attributes with which to explain the meaning of individual data items. When
used together, the International Standards can support the rapid design and reuse of form designs,
wrap and hide the complexity of semantic annotation from subject matter experts, and provide a ready
reference of associations and transformations for users seeking to collect and use interoperable data.
This document does not supplant or replace computer languages such as XForms, Windows Forms,
Adobe Forms or relevant parts of HTML, which describe how a form design is implemented, and is
deliberately devoid of domain or content specific semantics to ensure wide applicability. However,
given the universal applicability of forms, it should be of no surprise that elements of the model can be
recognized in many forms standards. Some of these have been mapped to this document in Annex A to
Annex E.
Forms may be printed on paper, or encoded in electronic format. Electronic forms may be rendered
natively in standard formats such as HTML, XForms or PDF, or propriety ones such as Windows forms,
Cocoa or Java Swing. They may also be implemented in a common survey framework such as Survey
Monkey or Lime Survey. Despite this diversity, it is eminently possible to create forms in different
formats that support the same comparisons and downstream processing provided the spaces and
instructions share the same semantic intent. Such a collection of forms could be said to share the same
design. A model that is adequate to record these form designs is the subject of this document.
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TECHNICAL SPECIFICATION ISO/IEC TS 19763-13:2016(E)
Information technology — Metamodel framework for
interoperability (MFI) —
Part 13:
Metamodel for form design registration
1 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.
2 Normative references
There are no normative references in this document.
3 Terms, definitions and abbreviated terms
3.1 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/IEC 19763-1, ISO/IEC 19763-
10, ISO/IEC 11179-3 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at http://www.iso.org/obp
3.1.1
attachment
digital object that is required as a response (3.1.15) to a question (3.1.14) on a form (3.1.9)
Note 1 to entry: Used to indicate that the response to a question includes a file on an accessible file-system that
will be loaded when the form transaction is complete.
3.1.2
combinator
operator that joins two constraints (3.1.6) (to make a binary constraint) returning a result based
upon both
EXAMPLE Conjunction, disjunction, implication.
3.1.3
compliance rule
specification for some aspect of a form design (3.1.10) that shall be satisfied for that
design to be a correct implementation of a form template (3.1.11)
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ISO/IEC TS 19763-13:2016(E)
3.1.4
completed form
form (3.1.9) for which responses (3.1.15) have been completed as required according to its instructions
(3.1.12) and rules (3.1.16)
3.1.5
consequence
expression (3.1.7) that sets or specifies some property of an element of a form design (3.1.10) when its
related constraint (3.1.6) evaluates to true
3.1.6
constraint
expression (3.1.7) about form design (3.1.10) elements that evaluates to a
Boolean value
3.1.7
expression
statement that evaluates to a string or numeric value
3.1.8
field
space on a form (3.1.9) for the recording of a response (3.1.15)
3.1.9
form
document or human interface comprising a structured collection of fields (3.1.8), suitable instructions
(3.1.12) and rules (3.1.16) that support the collection of specific information that may be subsequently
compared and processed in a routine fashion
3.1.10
form design
specification for the creation of equivalent forms (3.1.9) in different languages, applications and media
3.1.11
form template
partial form design (3.1.10) that establishes a pattern for the creation of other form designs
Note 1 to entry: A form template will often have empty or incomplete form sections with instructions describing
what kind of questions are required to create a completed design.
3.1.12
instruction
sentence that directs a person in some aspect of the completion or submission of a form (3.1.9)
3.1.13
owl:sameAs
property of the Web Ontology Language that indicates that individuals in an OWL DL ontology refer to
the same thing, or in OWL Full to additionally indicate that two classes are equal
Note 1 to entry: See http://www.w3.org/TR/owl-ref/#sameAs-def.
3.1.14
question
sentence worded or expressed so as to elicit information from a person
3.1.15
response
information elicited from a person by a question (3.1.14)
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ISO/IEC TS 19763-13:2016(E)
3.1.16
rule
principle guiding the behaviour of some aspect of a form (3.1.9)
3.1.17
section
subcomponent of a form (3.1.9) whose contained questions (3.1.14), instructions (3.1.12) and rules
(3.1.16) share a common purpose, meaning or context
3.1.18
skos:related
semantic relation asserting that the object of the labelled relationship is related to the subject
Note 1 to entry: See http://www.w3.org/TR/skos-reference.
3.2 Abbreviated terms
MFI Core and mapping
ISO/IEC 19763-10, Information technology — Metamodel framework for interoperability (MFI) —
Part 10: Core model and basic mapping
MDR Metamodel
ISO/IEC 11179-3, Information technology — Metadata registries (MDR) — Part 3: Registry metamodel
and basic attributes
MFI Form design registration
Information technology — Metamodel framework for interoperability (MFI) — Part 13: Metamodel for
form design registration
4 Conformance
4.1 General
An implementation claiming conformance with this document shall support the metamodel specified in
Clause 5, depending on a degree of conformance as described below.
4.2 Degrees of conformance
4.2.1 General
The distinction between “strictly conforming” and “conforming” implementations is necessary
to address the simultaneous needs for interoperability and extensions. This document describes
specifications that promote interoperability. Extensions are motivated by needs of users, vendors,
institutions and industries, but are not specified by this document.
A strictly conforming implementation may be limited in usefulness but is maximally interoperable
with respect to this document. A conforming implementation may be more useful, but may be less
interoperable with respect to this document.
4.2.2 Strictly conforming implementation
A strictly conforming implementation
a) shall support the metamodel specified in Clause 5, and
b) shall not support any extensions to the metamodel specified in Clause 5.
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ISO/IEC TS 19763-13:2016(E)
4.2.3 Conforming implementation
A conforming implementation
a) shall support the metamodel specified in Clause 5, and
b) may support extensions to the metamodel specified in Clause 5 that are consistent with the
metamodel and the MDR mapping package in Clause 5.
4.2.4 Implementation Conformance Statement (ICS)
An implementation claiming conformance with this document shall include an Implementation
Conformance Statement stating
a) whether it is a strictly conforming implementation or a conforming implementation (see 4.2.2), and
b) what extensions are supported if it is a conforming implementation (see 4.2.3).
Conformance statements for systems that implement this document shall additionally describe the
languages used to convey Rules, and the relationship types available for the Mapping_Relation class.
5 Structure of MFI form design registration
5.1 Overview of MFI form design registration
Figure 1 shows the metamodel for the registration of form designs.
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ISO/IEC TS 19763-13:2016(E)
Figure 1 — Form design metamodel
Forms have questions and sections that are constrained or unavailable for completion dependent upon
the answers given to earlier questions. Figure 2 is a model for the rule language used to describe such
dependencies between form elements: textual expressions in this language are used to complete the
rule attribute of the Form_Design_Element class.
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ISO/IEC TS 19763-13:2016(E)
Figure 2 — Rule
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ISO/IEC TS 19763-13:2016(E)
The metamodel for information model registration comprises the following metaclasses:
Attachment_Field Media_Element
Constant Operation
Datatype Presentation_Element
Expression Question_Element
Form_Design Response
Form_Design_Element Reference_Document
Form_Design_Template Rule
Form_Design_Language Section_Element
List_Field Text_Element
List_Item Text_Field
List_Item_Selected_State Variable
Localised_Text Unit_of_Measure
Lookup_Field
The purpose and use of the metamodel is described in detail in Annex A. Detailed specifications of the
metaclasses are provided in Annex B.
5.2 Relationship of metaclasses to the MDR Metamodel
As explained in ISO/IEC 19763-10, instances of the metaclasses defined in this subclause may be
extended by the types defined in the MDR Metamodel as follows.
— Form_Design may be extended as an Identified_Item, Designatable_Item, Registered_Item,
Administered_Item and Classifiable_Item.
— Form_Design_Element may be extended as an Identified_Item, Designatable_Item and
Classifiable_Item.
— Any instance of a Form_Design_Element may be mapped to an instance of a Concept.
— Any instance of a Question_Element may be mapped to an instance of a Data_Element.
— List_Item may be extended as an Identified_Item; any instance of which may be mapped to a
Concept and/or Permissible_Value.
— Rule may be extended as an Identified_Item and Designatable_Item.
5.3 Details provided in each metaclass definition
For each metaclass, the following details are shown:
— a definition that describes the role or significance of instances of the metaclass;
— the name of its immediate supertype;
— any alternative names (synonyms or aliases) for the metaclass;
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ISO/IEC TS 19763-13:2016(E)
— a list of attributes;
— a list of references.
For each attribute, the following details are shown:
a) the name of the attribute; where the attribute is one that is provided by the type defined in the
MDR metamodel by which when instances of the metaclass are extended, the name is italicized;
b) the datatype for values of the attribute;
c) the multiplicity of the attribute;
d) a description that describes the role or significance of values of the attribute.
For each reference, the following details are shown:
— the name of the reference; this is the role name that describes the role played by the referenced
metaclass with respect to the association identified by this reference;
— the name of the referenced metaclass;
— the multiplicity of the reference;
— a description that describes the role or significance of the instance, or instances, of the referenced
metaclass with respect to an instance of this metaclass;
— the name of the reference in the referenced metaclass that provides the inverse definition for the
association;
— an indication as to whether this metaclass is responsible for the maintenance of the association, i.e.
the precedence of the metaclass with respect to the associa
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