M11ReportSection08 - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

CommonLanguages

Starter

0..1

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

extension:versionAlgorithm

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..1

How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)

extension:experimental

0..1

For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental

extension:description

0..1

Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description

extension:purpose

0..1

Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose

extension:copyright

0..1

Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright

extension:copyrightLabel

0..1

extension:approvalDate

0..1

When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate

extension:lastReviewDate

0..1

extension:effectivePeriod

When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate

0..1

extension:additionalLanguage

When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod

0..*

extension:extendedContactDetail

The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language

0..*

ExtendedContactDetail

Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail

extension:publicationDate

0..1

extension:publicationStatus

Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate

0..1

Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)

?!Σ

0..*

Extensions that cannot be ignored
Slice: Unordered, Open by value:url

url

0..1

Canonical identifier for this Composition, represented as a URI (globally unique)

identifier

0..*

Identifier

Version-independent identifier for the Composition

0..1

An explicitly assigned identifier of a variation of the content in the Composition

consent

0..*

Reference(Consent)

Represents informed consents and medico-legal transactions

basedOn

0..*

Fulfills plan, proposal or order

status

?!Σ

1..1

1..1

Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://loinc.org

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: 35528-9

1..1

Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept
Required Pattern: CeSHarP Report

Slices for category

0..*

Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.

category:assessments

0..1

Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218590

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8-assessments

subject

0..*

Who and/or what the composition is about

encounter

0..1

Reference(Encounter)

Context of the Composition

1..1

Composition editing time

useContext

0..*

UsageContext

The context that the content is intended to support

0..*

Who and/or what authored the composition

participant

0..*

Identifies supporting entities, including parents, relatives, caregivers, insurance policyholders, guarantors, and others related in some way to the patient

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..*

Meaning and purpose of participation, in creation of the clinical document
Binding: FHIR Clinical Document Participant Types Value set (preferred): FHIR Clinical Document Participant Types. Author, Authenticator, Custodian, Legal Authenticator, Record Target and Subject are found in distinct, named fields in FHIR. Thus, these types are excluded.

function

0..*

Binding: ParticipationFunction (preferred): To specify the exact function an actor had in a service in all necessary detail.

0..1

Time period of participation

1..1

Who the participant is

name

ΣC

0..1

Computer friendly name
Constraints: cmp-4

0..1

Human Readable name/title

0..*

For any additional notes

classification

0..*

The assignment to an organizing scheme

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

The kind of classifier (e.g. population, intervention)
Binding: EvidenceClassifierTypeExample (example)

classifier

0..*

The specific classification value
Binding: ConditionProblemDiagnosisCodes (example)

attester

0..*

Attests to accuracy of composition

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

mode

1..1

reviewer | editor | endorser | informant | recorder
Binding: Contributor Role (preferred)

0..1

When the composition was attested

0..1

Who attested the composition

custodian

0..1

Reference(Organization | Patient | Group)

Organization which maintains the composition

Slices for relatesTo

0..*

Relationships to other compositions/documents
Slice: Unordered, Open by value:type

relatesTo:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..1

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: cite-as

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: part-of

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

relatesTo:derivedFrom

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: derived-from

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

relatesTo:specificationOf

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: specification-of

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: depends-on

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

relatesTo:supportedWith

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: supported-with

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: similar-to

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

event

0..*

The clinical service(s) being documented

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

period

0..1

The period covered by the documentation

detail

0..*

The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.

1..1

Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2, cmp-3

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:assessments

1..1

Composition is broken into sections
Constraints: cmp-1, cmp-2, cmp-3

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218590

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

8..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:considerations

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.1 Trial Assessments and Procedures Considerations

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218591

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

section:screeningBaseline

Nested Section

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.2 Screening/Baseline Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218592

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:efficacy

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.3 Efficacy Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218593

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:safety

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4 Safety Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218594

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4-safety-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:physical

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.1 Physical Examination

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218595

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:vitals

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.2 Vital Signs

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218596

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:ecg

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.3 Electrocardiograms

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218597

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:laboratory

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.4 Clinical Laboratory Assessments

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218598

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pregnancy

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.5 Pregnancy Testing

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218599

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:suicidal

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218600

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pharmacokinetics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.5 Pharmacokinetics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218601

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:biomarkers

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6 Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218602

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6-biomarkers

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

2..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:genetics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218603

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pharmacodynamics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.2 Pharmacodynamic Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218604

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:other

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.3 Other Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218605

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:immunogenicity

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.7 Immunogenicity Assessments

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218606

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:economics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.8 Medical Resource Utilisation and Health Economics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218607

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.8-economics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Documentation for this format

Nested Section

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.language	Base	required	All Languages	📍6.0.0-ballot5	FHIR Std.
Composition.status	Base	required	Composition Status	📍6.0.0-ballot5	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍6.0.0-ballot5	FHIR Std.
Composition.category	Base	example	Referenced Item Category Value Set	📍6.0.0-ballot5	FHIR Std.
Composition.category:assessments	Base	example	Referenced Item Category Value Set	📍6.0.0-ballot5	FHIR Std.
Composition.participant.type	Base	preferred	FHIR Clinical Document Participant Types Value set	📦1.0.0	THO v7.3
Composition.participant.function	Base	preferred	ParticipationFunction	📦3.0.0	THO v7.3
Composition.classification.type	Base	example	Evidence Classifier Type Example	📍6.0.0-ballot5	FHIR Std.
Composition.classification.classifier	Base	example	Condition/Problem/Diagnosis Codes	📍6.0.0-ballot5	FHIR Std.
Composition.attester.mode	Base	preferred	Contributor Role	📦1.0.0	THO v7.3
Composition.relatesTo.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:citeAs.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:partOf.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:derivedFrom.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:specificationOf.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:dependsOn.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:supportedWith.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:similarTo.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.event.detail	Base	example	v3 Code System ActCode	📦3.0.0	THO v7.3
Composition.section.code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:assessments.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section.code	Base	extensible	EvidenceReportSectionCode Value Set	📦1.0.0-ballot3	This IG
Composition.section:assessments.section.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:considerations.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:considerations.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:considerations.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:screeningBaseline.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:screeningBaseline.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:screeningBaseline.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:efficacy.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:efficacy.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:efficacy.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:physical.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:physical.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:physical.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:vitals.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:vitals.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:vitals.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:ecg.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:ecg.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:ecg.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:laboratory.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:laboratory.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:laboratory.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:pregnancy.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:pregnancy.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:pregnancy.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:suicidal.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:safety.section:suicidal.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:safety.section:suicidal.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:pharmacokinetics.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:pharmacokinetics.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:pharmacokinetics.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:biomarkers.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:biomarkers.section.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:genetics.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:genetics.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:biomarkers.section:genetics.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:biomarkers.section:pharmacodynamics.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:other.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:biomarkers.section:other.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:biomarkers.section:other.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:immunogenicity.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:immunogenicity.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:immunogenicity.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:economics.code	Base	example	Document Section Codes	📍6.0.0-ballot5	FHIR Std.
Composition.section:assessments.section:economics.orderedBy	Base	preferred	List Order Codes	📦2.0.0	THO v7.3
Composition.section:assessments.section:economics.emptyReason	Base	preferred	List Empty Reasons	📍6.0.0-ballot5	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
cmp-1	error	Composition.section, Composition.section:assessments	A section must contain at least one of text, entries, or sub-sections	`text.exists() or entry.exists() or section.exists()`
cmp-2	error	Composition.section, Composition.section:assessments	A section can only have an emptyReason if no entries are included	`emptyReason.empty() or entry.empty()`
cmp-3	warning	Composition.section, Composition.section:assessments	If attester exists then the Composition either needs a text or a section	`%resource.attester.exists() implies(text.exists() or section.exists())`
cmp-4	warning	Composition.name	Name should start with an uppercase letter (A–Z), be 2 to 255 characters long, and contain only letters, digits, and underscores. Whitespace, hyphens, and other punctuation are not permitted	`%resource.name.exists() implies %resource.name.matches('^[A-Z]([A-Za-z0-9_]){1,254}$')`
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Composition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`

Summary

Mandatory: 21 elements(45 nested mandatory elements)
Must-Support: 18 elements

Slices

This structure defines the following Slices:

The element 1 is sliced based on the value of Composition.category
The element 1 is sliced based on the value of Composition.section
The element 1 is sliced based on the value of Composition.section.section
The element 1 is sliced based on the value of Composition.section.section.section

Maturity: 1

Key Elements View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
Slices for extension				Content/Rules for all slices
extension:versionAlgorithm		0..1	Coding	How to compare versions URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm Binding: VersionAlgorithm (extensible)
extension:experimental		0..1	boolean	For testing purposes, not real usage URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental
extension:description		0..1	markdown	Natural language description of the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-description
extension:purpose		0..1	markdown	Why this artifact is defined URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose
extension:copyright		0..1	markdown	Use and/or publishing restrictions URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright
extension:copyrightLabel		0..1	string	Copyright holder and year(s) URL: http://hl7.org/fhir/StructureDefinition/artifact-copyrightLabel
extension:approvalDate		0..1	date	When the artifact was approved by publisher URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate
extension:lastReviewDate		0..1	date	When the artifact was approved by publisher URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate
extension:effectivePeriod		0..1	Period	When the artifact is expected to be used URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod
extension:additionalLanguage		0..*	code	The additional language URL: http://hl7.org/fhir/StructureDefinition/additional-language Binding: AllLanguages (required): IETF language tag for a human language
extension:extendedContactDetail		0..*	ExtendedContactDetail	Contact details for the publisher URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail
extension:publicationDate		0..1	date	Publication date of Resource URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate
extension:publicationStatus		0..1	CodeableConcept	Publication status URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status Binding: Cited Artifact Status Type (preferred)
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
status	?!Σ	1..1	code	registered \| partial \| preliminary \| final \| amended \| corrected \| appended \| cancelled \| entered-in-error \| deprecated \| unknown Binding: CompositionStatus (required): The workflow status of the composition.
type	Σ	1..1	CodeableConcept	Kind of composition (LOINC if possible) Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 35528-9
display		1..1	string	Representation defined by the system Fixed Value: Clinical trial protocol Clinical trial protocol
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	0..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
Slices for category	Σ	0..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
category:assessments	Σ	0..1	CodeableConcept	Categorization of Composition Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.
coding	Σ	1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218590
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
userSelected		0..1	boolean	If this coding was chosen directly by the user
text	Σ	1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
date	Σ	1..1	dateTime	Composition editing time
Slices for relatesTo		0..*	BackboneElement	Relationships to other compositions/documents Slice: Unordered, Open by value:type
relatesTo:All Slices				Content/Rules for all slices
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact.
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:citeAs		0..1	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: cite-as
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:partOf		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: part-of
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:derivedFrom		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: derived-from
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:specificationOf		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: specification-of
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:dependsOn		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: depends-on
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:supportedWith		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: supported-with
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
relatesTo:similarTo		0..*	BackboneElement	Relationships to other compositions/documents
Slices for extension				Content/Rules for all slices
extension:classifier		0..1	CodeableConcept	A classifier of the target artifact in a relatesTo element URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
type		1..1	CodeableConcept	documentation \| justification \| citation \| predecessor \| successor \| derived-from \| depends-on \| composed-of \| part-of \| amends \| amended-with \| appends \| appended-with \| cites \| cited-by \| comments-on \| comment-in \| contains \| contained-in \| corrects \| correction-in \| replaces \| replaced-with \| retracts \| retracted-by \| signs \| similar-to \| supports \| supported-with \| transforms \| transformed-into \| transformed-with \| documents \| specification-of \| created-with \| cite-as \| reprint \| reprint-of \| summarizes Binding: Artifact Relationship Type (extensible): The type of relationship to the related artifact. Required Pattern: At least the following
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
coding		1..*	Coding	Code defined by a terminology system Fixed Value: (Complex)
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations
system		1..1	uri	Identity of the terminology system Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type
version		0..1	string	Version of the system - if relevant
code		1..1	code	Symbol in syntax defined by the system Fixed Value: similar-to
display		0..1	string	Representation defined by the system
userSelected		0..1	boolean	If this coding was chosen directly by the user
text		0..1	string	Plain text representation of the concept
target[x]		1..1		The artifact that is related to this Composition
targetUri			uri
targetAttachment			Attachment
targetCanonical			canonical(Resource)
targetReference			Reference(Resource)
targetMarkdown			markdown
Slices for section	C	1..1	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text Constraints: cmp-1, cmp-2, cmp-3
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:assessments	SC	1..1	BackboneElement	Composition is broken into sections Constraints: cmp-1, cmp-2, cmp-3
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8 TRIAL ASSESSMENTS AND PROCEDURES
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		8..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:considerations	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.1 Trial Assessments and Procedures Considerations
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.2 Screening/Baseline Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:efficacy	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.3 Efficacy Assessments and Procedures
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:safety	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4 Safety Assessments and Procedures
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		0..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:physical	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.1 Physical Examination
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:vitals	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.2 Vital Signs
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:ecg	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.3 Electrocardiograms
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:laboratory	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.4 Clinical Laboratory Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pregnancy	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.5 Pregnancy Testing
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:suicidal	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.5 Pharmacokinetics
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:biomarkers	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6 Biomarkers
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section		2..*	See section (Composition)	Nested Section Slice: Unordered, Open by value:code.text
section:All Slices				Content/Rules for all slices
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
text	C	0..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Slices for section				Content/Rules for all slices
section:genetics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:pharmacodynamics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.2 Pharmacodynamic Biomarkers
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:other	S	0..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.3 Other Biomarkers
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:immunogenicity	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.7 Immunogenicity Assessments
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
section:economics	S	1..1	BackboneElement	Nested Section
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Slice: Unordered, Open by value:url
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.8 Medical Resource Utilisation and Health Economics
text	C	1..1	Narrative	Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
entry	C	0..*	Reference(Resource)	A reference to data that supports this section
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Composition.status	Base	required	Composition Status	📍6.0.0-ballot5	FHIR Std.
Composition.type	Base	preferred	FHIR Document Type Codes	📍6.0.0-ballot5	FHIR Std.
Composition.category	Base	example	Referenced Item Category Value Set	📍6.0.0-ballot5	FHIR Std.
Composition.category:assessments	Base	example	Referenced Item Category Value Set	📍6.0.0-ballot5	FHIR Std.
Composition.relatesTo.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:citeAs.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:partOf.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:derivedFrom.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:specificationOf.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:dependsOn.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:supportedWith.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3
Composition.relatesTo:similarTo.type	Base	extensible	Artifact Relationship Type	📦1.0.0	THO v7.3

Constraints

Id	Grade	Path(s)	Description	Expression
cmp-1	error	Composition.section, Composition.section:assessments	A section must contain at least one of text, entries, or sub-sections	`text.exists() or entry.exists() or section.exists()`
cmp-2	error	Composition.section, Composition.section:assessments	A section can only have an emptyReason if no entries are included	`emptyReason.empty() or entry.empty()`
cmp-3	warning	Composition.section, Composition.section:assessments	If attester exists then the Composition either needs a text or a section	`%resource.attester.exists() implies(text.exists() or section.exists())`
dom-2	error	Composition	If the resource is contained in another resource, it SHALL NOT contain nested Resources	`contained.contained.empty()`
dom-3	error	Composition	If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource	`contained.where((('#'+id.trace('id') in %resource.descendants().select(reference \| as(uri))) or descendants().where(reference='#' \| as(uri)='#').exists()).not()).trace('unmatched', id).empty()`
dom-4	error	Composition	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	`contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()`
dom-5	error	Composition	If a resource is contained in another resource, it SHALL NOT have a security label	`contained.meta.security.empty()`
dom-6	best practice	Composition	A resource should have narrative for robust management	text.`div`.exists()
ele-1	error	ALL elements	All FHIR elements must have a @value or children	`hasValue() or (children().count() > id.count())`

Differential View

Name	Flags	Card.	Type	Description & Constraints Filter: Bindings Constraints Obligations
Composition		0..*	EvidenceReport	A set of resources composed into a single coherent clinical statement with clinical attestation
type
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://loinc.org
code		1..1	code	Symbol in syntax defined by the system Fixed Value: 35528-9
display		1..1	string	Representation defined by the system Fixed Value: Clinical trial protocol Clinical trial protocol
text		0..1	string	Plain text representation of the concept Required Pattern: CeSHarP Report
Slices for category		0..*	CodeableConcept	Categorization of Composition Slice: Unordered, Open by value:text
category:assessments		0..1	CodeableConcept	Categorization of Composition
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218590
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
text		1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
Slices for section		1..1	BackboneElement	Composition is broken into sections Slice: Unordered, Open by value:code.text
section:assessments	S	1..1	BackboneElement	Composition is broken into sections
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8 TRIAL ASSESSMENTS AND PROCEDURES
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218590
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES
text		1..1	string	Plain text representation of the concept Required Pattern: section8-assessments
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		8..*		Nested Section Slice: Unordered, Open by value:code.text
Slices for section				Content/Rules for all slices
section:considerations	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.1 Trial Assessments and Procedures Considerations
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218591
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations
text		1..1	string	Plain text representation of the concept Required Pattern: section8.1-assessments-procedures
text		1..1	Narrative	Text summary of the section, for human interpretation
section:screeningBaseline	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.2 Screening/Baseline Assessments and Procedures
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218592
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures
text		1..1	string	Plain text representation of the concept Required Pattern: section8.2-screening-baseline-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:efficacy	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.3 Efficacy Assessments and Procedures
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218593
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures
text		1..1	string	Plain text representation of the concept Required Pattern: section8.3-efficacy-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:safety	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4 Safety Assessments and Procedures
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218594
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4-safety-assessments
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		0..*		Nested Section Slice: Unordered, Open by value:code.text
Slices for section				Content/Rules for all slices
section:physical	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.1 Physical Examination
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218595
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.1-physical-examination
text		1..1	Narrative	Text summary of the section, for human interpretation
section:vitals	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.2 Vital Signs
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218596
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.2-vital-signs
text		1..1	Narrative	Text summary of the section, for human interpretation
section:ecg	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.3 Electrocardiograms
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218597
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.3-electrocardiograms
text		1..1	Narrative	Text summary of the section, for human interpretation
section:laboratory	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.4 Clinical Laboratory Assessments
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218598
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.4-clinical-laboratory-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pregnancy	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.5 Pregnancy Testing
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218599
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.5-pregnancy-testing
text		1..1	Narrative	Text summary of the section, for human interpretation
section:suicidal	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218600
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring
text		1..1	string	Plain text representation of the concept Required Pattern: section8.4.6-suicidal-ideation
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pharmacokinetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.5 Pharmacokinetics
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218601
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics
text		1..1	string	Plain text representation of the concept Required Pattern: section8.5-pharmacokinetics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:biomarkers	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6 Biomarkers
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218602
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6-biomarkers
text		0..1	Narrative	Text summary of the section, for human interpretation
Slices for section		2..*		Nested Section Slice: Unordered, Open by value:code.text
Slices for section				Content/Rules for all slices
section:genetics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218603
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6.1-genetics-pharmacogenomics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:pharmacodynamics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.2 Pharmacodynamic Biomarkers
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218604
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6.2-pharmacodynamics
text		1..1	Narrative	Text summary of the section, for human interpretation
section:other	S	0..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.6.3 Other Biomarkers
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218605
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers
text		1..1	string	Plain text representation of the concept Required Pattern: section8.6.3-other-biomarkers
text		1..1	Narrative	Text summary of the section, for human interpretation
section:immunogenicity	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.7 Immunogenicity Assessments
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218606
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments
text		1..1	string	Plain text representation of the concept Required Pattern: section8.7-immunogenicity-assessments
text		1..1	Narrative	Text summary of the section, for human interpretation
section:economics	S	1..1	BackboneElement	Nested Section
title		0..1	string	Label for section (e.g. for ToC) Required Pattern: 8.8 Medical Resource Utilisation and Health Economics
code
coding		1..1	Coding	Code defined by a terminology system Required Pattern: At least the following
system		1..1	uri	Identity of the terminology system Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
code		1..1	code	Symbol in syntax defined by the system Fixed Value: C218607
display		1..1	string	Representation defined by the system Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics
text		1..1	string	Plain text representation of the concept Required Pattern: section8.8-economics
text		1..1	Narrative	Text summary of the section, for human interpretation
Documentation for this format

Snapshot ViewView

Description & Constraints Filter: Filters

Composition

0..*

EvidenceReport

A set of resources composed into a single coherent clinical statement with clinical attestation

0..1

Logical id of this artifact

Meta

Metadata about the resource

implicitRules

?!Σ

0..1

A set of rules under which this content was created

language

0..1

Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional Bindings

Purpose

CommonLanguages

Starter

0..1

Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

contained

0..*

Resource

Contained, inline Resources

0..*

extension:versionAlgorithm

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..1

How to compare versions
URL: http://hl7.org/fhir/StructureDefinition/artifact-versionAlgorithm
Binding: VersionAlgorithm (extensible)

extension:experimental

0..1

For testing purposes, not real usage
URL: http://hl7.org/fhir/StructureDefinition/artifact-experimental

extension:description

0..1

Natural language description of the artifact
URL: http://hl7.org/fhir/StructureDefinition/artifact-description

extension:purpose

0..1

Why this artifact is defined
URL: http://hl7.org/fhir/StructureDefinition/artifact-purpose

extension:copyright

0..1

Use and/or publishing restrictions
URL: http://hl7.org/fhir/StructureDefinition/artifact-copyright

extension:copyrightLabel

0..1

extension:approvalDate

0..1

When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-approvalDate

extension:lastReviewDate

0..1

extension:effectivePeriod

When the artifact was approved by publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-lastReviewDate

0..1

extension:additionalLanguage

When the artifact is expected to be used
URL: http://hl7.org/fhir/StructureDefinition/artifact-effectivePeriod

0..*

extension:extendedContactDetail

The additional language
URL: http://hl7.org/fhir/StructureDefinition/additional-language
Binding: AllLanguages (required): IETF language tag for a human language

0..*

ExtendedContactDetail

Contact details for the publisher
URL: http://hl7.org/fhir/StructureDefinition/artifact-extended-contact-detail

extension:publicationDate

0..1

extension:publicationStatus

Publication date of Resource
URL: http://hl7.org/fhir/StructureDefinition/artifact-publicationDate

0..1

Publication status
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
Binding: Cited Artifact Status Type (preferred)

?!Σ

0..*

Extensions that cannot be ignored
Slice: Unordered, Open by value:url

url

0..1

Canonical identifier for this Composition, represented as a URI (globally unique)

identifier

0..*

Identifier

Version-independent identifier for the Composition

0..1

An explicitly assigned identifier of a variation of the content in the Composition

consent

0..*

Reference(Consent)

Represents informed consents and medico-legal transactions

basedOn

0..*

Fulfills plan, proposal or order

status

?!Σ

1..1

1..1

Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://loinc.org

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: 35528-9

1..1

Representation defined by the system
Fixed Value: Clinical trial protocol Clinical trial protocol

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept
Required Pattern: CeSHarP Report

Slices for category

0..*

Categorization of Composition
Slice: Unordered, Open by value:text
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.

category:assessments

0..1

Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218590

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8-assessments

subject

0..*

Who and/or what the composition is about

encounter

0..1

Reference(Encounter)

Context of the Composition

1..1

Composition editing time

useContext

0..*

UsageContext

The context that the content is intended to support

0..*

Who and/or what authored the composition

participant

0..*

Identifies supporting entities, including parents, relatives, caregivers, insurance policyholders, guarantors, and others related in some way to the patient

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..*

function

0..*

Binding: ParticipationFunction (preferred): To specify the exact function an actor had in a service in all necessary detail.

0..1

Time period of participation

1..1

Who the participant is

name

ΣC

0..1

Computer friendly name
Constraints: cmp-4

0..1

Human Readable name/title

0..*

For any additional notes

classification

0..*

The assignment to an organizing scheme

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

The kind of classifier (e.g. population, intervention)
Binding: EvidenceClassifierTypeExample (example)

classifier

0..*

The specific classification value
Binding: ConditionProblemDiagnosisCodes (example)

attester

0..*

Attests to accuracy of composition

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

mode

1..1

reviewer | editor | endorser | informant | recorder
Binding: Contributor Role (preferred)

0..1

When the composition was attested

0..1

Who attested the composition

custodian

0..1

Reference(Organization | Patient | Group)

Organization which maintains the composition

Slices for relatesTo

0..*

Relationships to other compositions/documents
Slice: Unordered, Open by value:type

relatesTo:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..1

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: cite-as

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: part-of

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

relatesTo:derivedFrom

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: derived-from

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

relatesTo:specificationOf

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: specification-of

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: depends-on

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

relatesTo:supportedWith

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: supported-with

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

0..*

Relationships to other compositions/documents

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

Slices for extension

Content/Rules for all slices

0..1

A classifier of the target artifact in a relatesTo element
URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relatesto-classifier

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

1..1

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..*

Code defined by a terminology system
Fixed Value: (Complex)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://terminology.hl7.org/CodeSystem/artifact-relationship-type

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: similar-to

0..1

Representation defined by the system

0..1

If this coding was chosen directly by the user

0..1

Plain text representation of the concept

1..1

The artifact that is related to this Composition

targetUri

targetAttachment

targetCanonical

targetReference

targetMarkdown

event

0..*

The clinical service(s) being documented

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

period

0..1

The period covered by the documentation

detail

0..*

The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.

1..1

Composition is broken into sections
Slice: Unordered, Open by value:code.text
Constraints: cmp-1, cmp-2, cmp-3

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:assessments

1..1

Composition is broken into sections
Constraints: cmp-1, cmp-2, cmp-3

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218590

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

8..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: EvidenceReportSectionCode Value Set (extensible)

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:considerations

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.1 Trial Assessments and Procedures Considerations

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218591

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.1-assessments-procedures

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

section:screeningBaseline

Nested Section

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.2 Screening/Baseline Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218592

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.2-screening-baseline-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:efficacy

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.3 Efficacy Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218593

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.3-efficacy-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:safety

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4 Safety Assessments and Procedures

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218594

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4 Safety Assessments and Procedures

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4-safety-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:physical

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.1 Physical Examination

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218595

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.1 Physical Examination

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.1-physical-examination

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:vitals

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.2 Vital Signs

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218596

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.2 Vital Signs

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.2-vital-signs

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:ecg

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.3 Electrocardiograms

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218597

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.3 Electrocardiograms

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.3-electrocardiograms

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:laboratory

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.4 Clinical Laboratory Assessments

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218598

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.4-clinical-laboratory-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pregnancy

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.5 Pregnancy Testing

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218599

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.5 Pregnancy Testing

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.5-pregnancy-testing

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:suicidal

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218600

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.4.6-suicidal-ideation

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pharmacokinetics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.5 Pharmacokinetics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218601

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.5 Pharmacokinetics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.5-pharmacokinetics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:biomarkers

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6 Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218602

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6 Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6-biomarkers

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

2..*

Nested Section
Slice: Unordered, Open by value:code.text

section:All Slices

Content/Rules for all slices

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

0..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

Slices for section

Content/Rules for all slices

section:genetics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218603

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.1-genetics-pharmacogenomics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:pharmacodynamics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.2 Pharmacodynamic Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218604

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.2-pharmacodynamics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:other

0..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.6.3 Other Biomarkers

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218605

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.6.3 Other Biomarkers

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.6.3-other-biomarkers

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:immunogenicity

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.7 Immunogenicity Assessments

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218606

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.7 Immunogenicity Assessments

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.7-immunogenicity-assessments

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*

Nested Section

section:economics

1..1

Nested Section

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

?!Σ

0..*

Extensions that cannot be ignored even if unrecognized
Slice: Unordered, Open by value:url

0..1

Label for section (e.g. for ToC)
Required Pattern: 8.8 Medical Resource Utilisation and Health Economics

0..1

Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations
Slice: Unordered, Open by value:url

1..1

Code defined by a terminology system

Required Pattern: At least the following

0..1

Unique id for inter-element referencing

0..*

Additional content defined by implementations

1..1

Identity of the terminology system
Fixed Value: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl

0..1

Version of the system - if relevant

1..1

Symbol in syntax defined by the system
Fixed Value: C218607

1..1

Representation defined by the system
Fixed Value: ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics

0..1

If this coding was chosen directly by the user

1..1

Plain text representation of the concept
Required Pattern: section8.8-economics

0..*

Who and/or what authored the section, when the section is authored by someone other than the composition.author

0..1

Who/what the section is about, when it is not about the subject of the composition

1..1

Text summary of the section, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements

0..*

Information about the section contents that is not represented by any of the section entries

0..1

Order of section entries
Binding: List Order Codes (preferred): What order applies to the items in the entry.

0..*

A reference to data that supports this section

0..1

Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

0..*