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Logical Model: CSU_C09 (MsgStruct) ( Experimental )

Clinical Trial Message

Usage:

• This Logical Model Profile is not used by any profiles in this Implementation Guide

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from DomainResource

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	CSU_C09	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	CSU_C09	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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	CSU_C09	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	CSU_C09	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	CSU_C09	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())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
CSU_C09.language	required	AllLanguages

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	CSU_C09	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	CSU_C09	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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	CSU_C09	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	CSU_C09	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	CSU_C09	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())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from DomainResource

Summary

Mandatory: 0 element (21 nested mandatory elements)
Must-Support: 21 elements

Differential View

This structure is derived from DomainResource

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	CSU_C09	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	CSU_C09	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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	CSU_C09	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	CSU_C09	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	CSU_C09	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())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
CSU_C09		1..1	DomainResource	Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension A resource with narrative, extensions, and contained resources Instances of this logical model are not marked to be the target of a Reference
id	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
language		0..1	code	Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored Slice: Unordered, Open by value:url
MSH	S	1..1	MSH	Message Header
ARV		0..*	ARV	Access Restriction
SFT		0..*	SFT	Software Segment
UAC		0..1	UAC	User Authentication Credential Segment
PATIENT	S	1..1		PATIENT Group
PID	S	1..1	PID	Patient Identification
PD1		0..1	PD1	Patient Additional Demographic
PRT		0..*	PRT	Participation Information
ARV		0..*	ARV	Access Restriction
NTE		0..*	NTE	Notes and Comments
VISIT	S	1..1		VISIT Group
PV1	S	1..1	PV1	Patient Visit
PV2		0..1	PV2	Patient Visit - Additional Information
PRT		0..*	PRT	Participation Information
CSR	S	1..1	CSR	Clinical Study Registration
STUDY_PHASE	S	1..1		STUDY_PHASE Group
CSP		0..1	CSP	Clinical Study Phase
STUDY_SCHEDULE	S	1..1		STUDY_SCHEDULE Group
CSS		0..1	CSS	Clinical Study Data Schedule Segment
STUDY_OBSERVATION	S	1..1		STUDY_OBSERVATION Group
STUDY_OBSERVATION_ORDER	S	1..1		STUDY_OBSERVATION_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
OBR	S	1..1	OBR	Observation Request
PRT		0..*	PRT	Participation Information
TIMING_QTY	S	1..1		TIMING_QTY Group
TQ1	S	1..1	TQ1	Timing/Quantity
TQ2		0..*	TQ2	Timing/Quantity Relationship
OBX	S	1..1	OBX	Observation/Result
PRT		0..*	PRT	Participation Information
STUDY_PHARM	S	1..1		STUDY_PHARM Group
COMMON_ORDER	S	1..1		COMMON_ORDER Group
ORC	S	1..1	ORC	Common Order
PRT		0..*	PRT	Participation Information
RX_ADMIN	S	1..1		RX_ADMIN Group
RXA	S	1..1	RXA	Pharmacy/Treatment Administration
RXR	S	1..1	RXR	Pharmacy/Treatment Route
PRT		0..*	PRT	Participation Information
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet
CSU_C09.language	required	AllLanguages

Constraints

Id	Grade	Path(s)	Details	Requirements
dom-2	error	CSU_C09	If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty()
dom-3	error	CSU_C09	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 in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	CSU_C09	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	CSU_C09	If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty()
dom-6	best practice	CSU_C09	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())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from DomainResource

Summary

Mandatory: 0 element (21 nested mandatory elements)
Must-Support: 21 elements

Other representations of profile: CSV, Excel