Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2 International flag

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

Extension:

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement Version: 1.0.0-ballot2
Standards status: Trial-use Active as of 2026-04-02 Maturity Level: 2 Computable Name: M11_ConfidentialityStatement

Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement

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:

You can also check for usages in the FHIR IG Statistics

Formal Views of Extension Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Sponsor Confidentiality Statement, if applicable.
... extension 0..0 Extension
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"
... value[x] 0..1 string Value of extension

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Sponsor Confidentiality Statement, if applicable.
... 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 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"

doco 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

Simple Extension with the type string: Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement

Maturity: 2

Differential ViewDifferential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Sponsor Confidentiality Statement, if applicable.
... extension 0..0 Extension
... url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"
... value[x] 0..1 string Value of extension

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. Extension 0..* Extension Sponsor Confidentiality Statement, if applicable.
... 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 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"

doco 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

Simple Extension with the type string: Sponsor Confidentiality Statement. This is a replica of EBM ResearchStudySponsorConfidentialityStatement

Maturity: 2

 

Other representations of profile: CSV, Excel, Schematron