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:

Approval and sign off for an M11 CeSHarP digital protocol.

Context of Use

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

• Element ID: ResearchStudy

Usage info

Usages:

• Use this Extension: M11ResearchStudy
• 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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Approval and sign off
Slices for extension				Content/Rules for all slices
extension:approvalDate		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"approvalDate"
value[x]		0..1	date	Date of approval
extension:signature		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signature"
value[x]		0..1	Signature	Signature
extension:signatureUrl		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureUrl"
value[x]		0..1	string	Signature URL
extension:signatureMethod		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureMethod"
value[x]		0..1	string	Signature method
url		1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval"
value[x]		0..0		Value of extension
Documentation for this format

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Approval and sign off
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:approvalDate		0..1	Extension	Extension
id		0..1	string	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	Date of approval
extension:signature		0..1	Extension	Extension
id		0..1	string	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	Signature
extension:signatureUrl		0..1	Extension	Extension
id		0..1	string	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	string	Signature URL
extension:signatureMethod		0..1	Extension	Extension
id		0..1	string	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	Signature method
url	Σ	1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval"
Documentation for this format

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()

Summary

Complex Extension: Approval and sign off for an M11 CeSHarP digital protocol.

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

Maturity: 1

Differential ViewDifferential View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Approval and sign off
Slices for extension				Content/Rules for all slices
extension:approvalDate		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"approvalDate"
value[x]		0..1	date	Date of approval
extension:signature		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signature"
value[x]		0..1	Signature	Signature
extension:signatureUrl		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureUrl"
value[x]		0..1	string	Signature URL
extension:signatureMethod		0..1	Extension	Extension
extension		0..0		Extension
url		1..1	uri	"signatureMethod"
value[x]		0..1	string	Signature method
url		1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval"
value[x]		0..0		Value of extension
Documentation for this format

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
Extension		0..*	Extension	Approval and sign off
id		0..1	string	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url
extension:approvalDate		0..1	Extension	Extension
id		0..1	string	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	Date of approval
extension:signature		0..1	Extension	Extension
id		0..1	string	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	Signature
extension:signatureUrl		0..1	Extension	Extension
id		0..1	string	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	string	Signature URL
extension:signatureMethod		0..1	Extension	Extension
id		0..1	string	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	Signature method
url	Σ	1..1	uri	"http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-m11-approval"
Documentation for this format

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()

Summary

Complex Extension: Approval and sign off for an M11 CeSHarP digital protocol.

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

Maturity: 1

Other representations of profile: CSV, Excel, Schematron