Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

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Extension:

Context of Use

This extension may be used on the following element(s)

• Extension: ResearchStudyM11ProtocolAmendment

Usage info

Usages:

• Use this Extension: ResearchStudyM11ProtocolAmendment
• Examples for this Extension: NCT03421379_FHIR_Transform_M11_IGBJ

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

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

This structure is derived from Extension

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Provides number or percentage of each group affected by a single amendment
Extension.extension		2..*	Extension	Extension
Extension.Slices for extension				Content/Rules for all slices
Extension.Slices for extension.extension:number		1..1	Extension	Extension
Extension.Slices for extension.extension:number.extension		0..0		Extension
Extension.Slices for extension.extension:number.url		1..1	uri	"number"
Extension.Slices for extension.extension:number.value[x]		0..1		Number of participants, or % of participants
Extension.Slices for extension.extension:number.value[x].valuePositiveInt			positiveInt
Extension.Slices for extension.extension:number.value[x].valueQuantity			Quantity
Extension.Slices for extension.extension:scope		1..1	Extension	Extension
Extension.Slices for extension.extension:scope.extension		0..0		Extension
Extension.Slices for extension.extension:scope.url		1..1	uri	"scope"
Extension.Slices for extension.extension:scope.value[x]		0..1	CodeableConcept	Global, Locally, or By Cohort Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.url		1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"
Extension.value[x]		0..0		Value of extension
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Extension.extension:scope.​value[x]	Base	required	ICH M11 Amendment Scope Enrollment Value Set	📦1.0.0-ballot3	This IG

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Provides number or percentage of each group affected by a single amendment
Extension.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:number		1..1	Extension	Extension
Extension.Slices for extension.extension:number.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension.extension:number.extension		0..0		Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:number.url	Σ This element is included in summaries.	1..1	uri	"number"
Extension.Slices for extension.extension:number.value[x]	Σ This element is included in summaries.	0..1		Number of participants, or % of participants
Extension.Slices for extension.extension:number.value[x].valuePositiveInt			positiveInt
Extension.Slices for extension.extension:number.value[x].valueQuantity			Quantity
Extension.Slices for extension.extension:scope		1..1	Extension	Extension
Extension.Slices for extension.extension:scope.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension.extension:scope.extension		0..0		Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scope.url	Σ This element is included in summaries.	1..1	uri	"scope"
Extension.Slices for extension.extension:scope.value[x]	Σ This element is included in summaries.	0..1	CodeableConcept	Global, Locally, or By Cohort Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.url	Σ This element is included in summaries.	1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Extension.extension:scope.​value[x]	Base	required	ICH M11 Amendment Scope Enrollment Value Set	📦1.0.0-ballot3	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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 Extension

Summary

Complex Extension: Provides number or percentage of each group affected by a single amendment.

• number: positiveInt, Quantity: An Extension
• scope: CodeableConcept: An Extension

Maturity: 1

Differential View

This structure is derived from Extension

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Provides number or percentage of each group affected by a single amendment
Extension.extension		2..*	Extension	Extension
Extension.Slices for extension				Content/Rules for all slices
Extension.Slices for extension.extension:number		1..1	Extension	Extension
Extension.Slices for extension.extension:number.extension		0..0		Extension
Extension.Slices for extension.extension:number.url		1..1	uri	"number"
Extension.Slices for extension.extension:number.value[x]		0..1		Number of participants, or % of participants
Extension.Slices for extension.extension:number.value[x].valuePositiveInt			positiveInt
Extension.Slices for extension.extension:number.value[x].valueQuantity			Quantity
Extension.Slices for extension.extension:scope		1..1	Extension	Extension
Extension.Slices for extension.extension:scope.extension		0..0		Extension
Extension.Slices for extension.extension:scope.url		1..1	uri	"scope"
Extension.Slices for extension.extension:scope.value[x]		0..1	CodeableConcept	Global, Locally, or By Cohort Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.url		1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"
Extension.value[x]		0..0		Value of extension
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
Extension.extension:scope.​value[x]	Base	required	ICH M11 Amendment Scope Enrollment Value Set	📦1.0.0-ballot3	This IG

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Provides number or percentage of each group affected by a single amendment
Extension.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension		2..*	Extension	Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:number		1..1	Extension	Extension
Extension.Slices for extension.extension:number.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension.extension:number.extension		0..0		Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:number.url	Σ This element is included in summaries.	1..1	uri	"number"
Extension.Slices for extension.extension:number.value[x]	Σ This element is included in summaries.	0..1		Number of participants, or % of participants
Extension.Slices for extension.extension:number.value[x].valuePositiveInt			positiveInt
Extension.Slices for extension.extension:number.value[x].valueQuantity			Quantity
Extension.Slices for extension.extension:scope		1..1	Extension	Extension
Extension.Slices for extension.extension:scope.id		0..1	string	Unique id for inter-element referencing
Extension.Slices for extension.extension:scope.extension		0..0		Extension Slice: Unordered, Open by value:url
Extension.Slices for extension.extension:scope.url	Σ This element is included in summaries.	1..1	uri	"scope"
Extension.Slices for extension.extension:scope.value[x]	Σ This element is included in summaries.	0..1	CodeableConcept	Global, Locally, or By Cohort Binding: ICH M11 Amendment Scope Enrollment Value Set (required)
Extension.url	Σ This element is included in summaries.	1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-amendment-scope-impact"
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
Extension.extension:scope.​value[x]	Base	required	ICH M11 Amendment Scope Enrollment Value Set	📦1.0.0-ballot3	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
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 Extension

Summary

Complex Extension: Provides number or percentage of each group affected by a single amendment.

• number: positiveInt, Quantity: An Extension
• scope: CodeableConcept: An Extension

Maturity: 1

Other representations of profile: CSV, Excel, Schematron