Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

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Extension:

Approval and sign off

Context of Use

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

• Element ID: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy

Usage info

Usages:

• Use this Extension: M11 Research Study Profile
• Examples for this Extension: ResearchStudy/Exemplar-ResearchStudy-001 and ResearchStudy/Exemplar-ResearchStudy-Current-Amendment

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension	C	0..*	Extension	Sign-off details Constraints: date-required
Slices for extension				Content/Rules for all slices
extension:approvalDate	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"approvalDate"
value[x]		0..1	date	Value of extension
extension:signature		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signature"
value[x]		0..1	Signature	Value of extension
extension:signatureUrl	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureUrl"
value[x]		0..1		Value of extension
valueString			string
valueUrl			url
extension:signatureMethod		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureMethod"
value[x]		0..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
value[x]		0..0		Value of extension
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	Extension	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension	C	0..*	Extension	Sign-off details Constraints: date-required
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:approvalDate	S	0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"approvalDate"
value[x]	Σ	0..1	date	Value of extension
extension:signature		0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signature"
value[x]	Σ	0..1	Signature	Value of extension
extension:signatureUrl	S	0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signatureUrl"
value[x]	Σ	0..1		Value of extension
valueString			string
valueUrl			url
extension:signatureMethod		0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signatureMethod"
value[x]	Σ	0..1	string	Value of extension
url	Σ	1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	Extension	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').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()

Summary

Complex Extension: Approval and sign off

• approvalDate: date: An Extension
• signature: Signature: An Extension
• signatureUrl: string, url: An Extension
• signatureMethod: string: An Extension

Maturity: 2

Differential ViewDifferential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension	C	0..*	Extension	Sign-off details Constraints: date-required
Slices for extension				Content/Rules for all slices
extension:approvalDate	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"approvalDate"
value[x]		0..1	date	Value of extension
extension:signature		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signature"
value[x]		0..1	Signature	Value of extension
extension:signatureUrl	S	0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureUrl"
value[x]		0..1		Value of extension
valueString			string
valueUrl			url
extension:signatureMethod		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureMethod"
value[x]		0..1	string	Value of extension
url		1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
value[x]		0..0		Value of extension
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	Extension	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension	C	0..*	Extension	Sign-off details Constraints: date-required
id		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:approvalDate	S	0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"approvalDate"
value[x]	Σ	0..1	date	Value of extension
extension:signature		0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signature"
value[x]	Σ	0..1	Signature	Value of extension
extension:signatureUrl	S	0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signatureUrl"
value[x]	Σ	0..1		Value of extension
valueString			string
valueUrl			url
extension:signatureMethod		0..1	Extension	Extension
id		0..1	id	Unique id for inter-element referencing
extension		0..0		Extension Slice: Unordered, Open by value:url
url	Σ	1..1	uri	"signatureMethod"
value[x]	Σ	0..1	string	Value of extension
url	Σ	1..1	uri	"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
Documentation for this format

Constraints

Id	Grade	Path(s)	Description	Expression
date-required	warning	Extension	At least one of approvalDate or signatureUrl SHOULD be populated.	extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').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()

Summary

Complex Extension: Approval and sign off

• approvalDate: date: An Extension
• signature: Signature: An Extension
• signatureUrl: string, url: An Extension
• signatureMethod: string: An Extension

Maturity: 2

Other representations of profile: CSV, Excel, Schematron