Common Data Models Harmonization
1.0.0 - STU 1 Publication
Common Data Models Harmonization
1.0.0 - STU 1 Publication
This page is part of the Common Data Models Harmonization FHIR IG (v1.0.0: STU 1) based on FHIR R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions 
XML representation of the cdmh-researchstudy resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="cdmh-researchstudy"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-cdmh-researchstudy-definitions.html#ResearchStudy" title="Sets expectations for supported capabilities for ResearchStudy resource in CDMH IG.">ResearchStudy</a><a name="ResearchStudy"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/researchstudy.html">ResearchStudy</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">CDMH ResearchStudy</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-cdmh-researchstudy-definitions.html#ResearchStudy.status">status</a><a name="ResearchStudy.status"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-cdmh-researchstudy-definitions.html#ResearchStudy.enrollment">enrollment</a><a name="ResearchStudy.enrollment"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-cdmh-group.html">CDMH Group</a>)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Inclusion & exclusion criteria</span><br/></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<url
value="http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-researchstudy"/>
<version value="1.0.0"/>
<name value="CdmhResearchStudy"/>
<title value="CDMH ResearchStudy"/>
<status value="draft"/>
<experimental value="false"/>
<date value="2019-09-01"/>
<publisher
value="HL7 International - Biomedical Research and Regulation Work Group"/>
<contact>
<telecom>
<system value="url"/>
<value value="http://hl7.org/Special/committees/rcrim"/>
</telecom>
</contact>
<description value="This is the ResearchStudy Resource profile for the IG."/>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="US"/>
</coding>
</jurisdiction>
<copyright
value="Used by permission of HL7, all rights reserved Creative Commons License"/>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="BRIDG5.1"/>
<uri value="https://bridgmodel.nci.nih.gov"/>
<name value="BRIDG 5.1 Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 v2 Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<uri value="http://clinicaltrials.gov"/>
<name value="ClinicalTrials.gov Mapping"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="ResearchStudy"/>
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
<derivation value="constraint"/>
<snapshot>
<element id="ResearchStudy">
<path value="ResearchStudy"/>
<short value="CDMH ResearchStudy"/>
<definition
value="Sets expectations for supported capabilities for ResearchStudy resource in CDMH IG."/>
<comment value="Need to make sure we encompass public health studies."/>
<alias value="Clinical Trial"/>
<alias value="Study"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<xpath value="not(parent::f:contained and f:contained)"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="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"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<xpath
value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mustSupport value="false"/>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchStudy.id">
<path value="ResearchStudy.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchStudy.meta">
<path value="ResearchStudy.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchStudy.implicitRules">
<path value="ResearchStudy.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="ResearchStudy.language">
<path value="ResearchStudy.language"/>
<short value="Language of the resource content"/>
<definition value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</binding>
</element>
<element id="ResearchStudy.text">
<path value="ResearchStudy.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="ResearchStudy.contained">
<path value="ResearchStudy.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.extension">
<path value="ResearchStudy.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.modifierExtension">
<path value="ResearchStudy.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.identifier">
<path value="ResearchStudy.identifier"/>
<short value="Business Identifier for study"/>
<definition
value="Identifiers assigned to this research study by the sponsor or other systems."/>
<requirements
value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Organization's Unique Protocol ID; Secondary IDs"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchStudy.title">
<path value="ResearchStudy.title"/>
<short value="Name for this study"/>
<definition
value="A short, descriptive user-friendly label for the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.title"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Brief Title"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/>
</mapping>
</element>
<element id="ResearchStudy.protocol">
<path value="ResearchStudy.protocol"/>
<short value="Steps followed in executing study"/>
<definition
value="The set of steps expected to be performed as part of the execution of the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.protocol"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Interventions; Arm/Intervention Cross-Reference"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocumentVersionPublicTitle.name"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".outboundRelationship[typeCode=DEFN].target"/>
</mapping>
</element>
<element id="ResearchStudy.partOf">
<path value="ResearchStudy.partOf"/>
<short value="Part of larger study"/>
<definition
value="A larger research study of which this particular study is a component or step."/>
<requirements
value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/>
<alias value="container"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.partOf"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="CompanionStudyRelationship"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchStudy.status">
<path value="ResearchStudy.status"/>
<short
value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn"/>
<definition value="The current state of the study."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchStudy.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyStatus"/>
</extension>
<strength value="required"/>
<description
value="Codes that convey the current status of the research study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyOverallStatus.code"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
</element>
<element id="ResearchStudy.primaryPurposeType">
<path value="ResearchStudy.primaryPurposeType"/>
<short
value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/>
<definition
value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.primaryPurposeType"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyPrimaryPurposeType"/>
</extension>
<strength value="extensible"/>
<description value="Codes for the main intent of the study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/>
</binding>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.primaryPurposeTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.phase">
<path value="ResearchStudy.phase"/>
<short
value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/>
<definition
value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.phase"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyPhase"/>
</extension>
<strength value="example"/>
<description
value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
<valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Study Phase"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.phaseCode"/>
</mapping>
</element>
<element id="ResearchStudy.category">
<path value="ResearchStudy.category"/>
<short value="Classifications for the study"/>
<definition
value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.category"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyCategory"/>
</extension>
<strength value="example"/>
<description
value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.focus">
<path value="ResearchStudy.focus"/>
<short value="Drugs, devices, etc. under study"/>
<definition
value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.focus"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyFocus"/>
</extension>
<strength value="example"/>
<description
value="Codes for medications, devices and other interventions."/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Focus of Study"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="InterventionalStudyProtocol.interventionTypeCode"/>
</mapping>
</element>
<element id="ResearchStudy.condition">
<path value="ResearchStudy.condition"/>
<short value="Condition being studied"/>
<definition
value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.condition"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ConditionCode"/>
</extension>
<strength value="example"/>
<description value="Identification of the condition or diagnosis."/>
<valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Conditions"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.what[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyCondition.code"/>
</mapping>
</element>
<element id="ResearchStudy.contact">
<path value="ResearchStudy.contact"/>
<short value="Contact details for the study"/>
<definition
value="Contact details to assist a user in learning more about or engaging with the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.contact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="ContactDetail"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"/>
</mapping>
</element>
<element id="ResearchStudy.relatedArtifact">
<path value="ResearchStudy.relatedArtifact"/>
<short value="References and dependencies"/>
<definition value="Citations, references and other related documents."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.relatedArtifact"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="RelatedArtifact"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Citations, Links, Available Study Data/Documents"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/>
</mapping>
</element>
<element id="ResearchStudy.keyword">
<path value="ResearchStudy.keyword"/>
<short value="Used to search for the study"/>
<definition
value="Key terms to aid in searching for or filtering the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.keyword"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyKeyword"/>
</extension>
<strength value="example"/>
<description
value="Words associated with the study that may be useful in discovery."/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Keywords"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/>
</mapping>
</element>
<element id="ResearchStudy.location">
<path value="ResearchStudy.location"/>
<short value="Geographic region(s) for study"/>
<definition
value="Indicates a country, state or other region where the study is taking place."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.location"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Jurisdiction"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="extensible"/>
<description
value="Countries and regions within which this artifact is targeted for use."/>
<valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/>
</binding>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolVersion.participatingLocationCode"/>
</mapping>
</element>
<element id="ResearchStudy.description">
<path value="ResearchStudy.description"/>
<short value="What this is study doing"/>
<definition
value="A full description of how the study is being conducted."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="markdown"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Detailed Description"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyProtocolDocumentVersion.publicDescription"/>
</mapping>
</element>
<element id="ResearchStudy.enrollment">
<path value="ResearchStudy.enrollment"/>
<short value="Inclusion & exclusion criteria"/>
<definition
value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"."/>
<comment
value="The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource."/>
<alias value="patient"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.enrollment"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-group"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map
value="Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="InterventionalStudyProtocol.interventionGroupQuantity"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".participation[typeCode=SBJ].role"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.subject"/>
</mapping>
</element>
<element id="ResearchStudy.period">
<path value="ResearchStudy.period"/>
<short value="When the study began and ended"/>
<definition
value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/>
<alias value="timing"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Study Start Date (start); Study Completion Date (end)"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.done[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".effectiveTime"/>
</mapping>
</element>
<element id="ResearchStudy.sponsor">
<path value="ResearchStudy.sponsor"/>
<short
value="Organization that initiates and is legally responsible for the study"/>
<definition
value="An organization that initiates the investigation and is legally responsible for the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.sponsor"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Sponsor"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.actor"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator">
<path value="ResearchStudy.principalInvestigator"/>
<short value="Researcher who oversees multiple aspects of the study"/>
<definition
value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.principalInvestigator"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Practitioner"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Principal Investigator"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.actor"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyInvestigator"/>
</mapping>
</element>
<element id="ResearchStudy.site">
<path value="ResearchStudy.site"/>
<short value="Facility where study activities are conducted"/>
<definition value="A facility in which study activities are conducted."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.site"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Facility"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.where[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="PlannedStudySite; StudySite"/>
</mapping>
</element>
<element id="ResearchStudy.reasonStopped">
<path value="ResearchStudy.reasonStopped"/>
<short
value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design"/>
<definition
value="A description and/or code explaining the premature termination of the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.reasonStopped"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyReasonStopped"/>
</extension>
<strength value="example"/>
<description value="Codes for why the study ended prematurely."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Why Study Stopped"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="FiveWs.why[x]"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyOverallStatus.studyStoppedReasonCode"/>
</mapping>
</element>
<element id="ResearchStudy.note">
<path value="ResearchStudy.note"/>
<short value="Comments made about the study"/>
<definition
value="Comments made about the study by the performer, subject or other participants."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.note"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Annotation"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="No BRIDG mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/>
</mapping>
</element>
<element id="ResearchStudy.arm">
<path value="ResearchStudy.arm"/>
<short value="Defined path through the study for a subject"/>
<definition
value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.arm"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arms"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm"/>
</mapping>
</element>
<element id="ResearchStudy.arm.id">
<path value="ResearchStudy.arm.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.arm.extension">
<path value="ResearchStudy.arm.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.arm.modifierExtension">
<path value="ResearchStudy.arm.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.arm.name">
<path value="ResearchStudy.arm.name"/>
<short value="Label for study arm"/>
<definition
value="Unique, human-readable label for this arm of the study."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.name"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Label"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.name"/>
</mapping>
</element>
<element id="ResearchStudy.arm.type">
<path value="ResearchStudy.arm.type"/>
<short value="Categorization of study arm"/>
<definition
value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Type"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.typeCode"/>
</mapping>
</element>
<element id="ResearchStudy.arm.description">
<path value="ResearchStudy.arm.description"/>
<short value="Short explanation of study path"/>
<definition
value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.arm.description"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Description"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="Arm.description"/>
</mapping>
</element>
<element id="ResearchStudy.objective">
<path value="ResearchStudy.objective"/>
<short value="A goal for the study"/>
<definition
value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchStudy.objective"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="BackboneElement"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyObjective"/>
</mapping>
</element>
<element id="ResearchStudy.objective.id">
<path value="ResearchStudy.objective.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.objective.extension">
<path value="ResearchStudy.objective.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.objective.modifierExtension">
<path value="ResearchStudy.objective.modifierExtension"/>
<short value="Extensions that cannot be ignored even if unrecognized"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<constraint>
<key value="ext-1"/>
<severity value="error"/>
<human value="Must have either extensions or value[x], not both"/>
<expression value="extension.exists() != value.exists()"/>
<xpath
value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/>
<source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.objective.name">
<path value="ResearchStudy.objective.name"/>
<short value="Label for the objective"/>
<definition
value="Unique, human-readable label for this objective of the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.objective.name"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="No BRIDG mapping (BRIDG has a description, but not a name)"/>
</mapping>
</element>
<element id="ResearchStudy.objective.type">
<path value="ResearchStudy.objective.type"/>
<short value="primary | secondary | exploratory"/>
<definition value="The kind of study objective."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchStudy.objective.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchStudyObjectiveType"/>
</extension>
<strength value="preferred"/>
<description value="Codes for the kind of study objective."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/>
</binding>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudyObjective.typeCode"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="ResearchStudy">
<path value="ResearchStudy"/>
<short value="CDMH ResearchStudy"/>
<definition
value="Sets expectations for supported capabilities for ResearchStudy resource in CDMH IG."/>
<mustSupport value="false"/>
</element>
<element id="ResearchStudy.status">
<path value="ResearchStudy.status"/>
<min value="1"/>
<max value="1"/>
<mustSupport value="true"/>
</element>
<element id="ResearchStudy.enrollment">
<path value="ResearchStudy.enrollment"/>
<min value="0"/>
<max value="*"/>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/us/cdmh/StructureDefinition/cdmh-group"/>
</type>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>
IG © 2019+ HL7 International - Biomedical Research and Regulation Work Group. Package hl7.fhir.us.cdmh#1.0.0 based on FHIR 4.0.1. Generated 2021-12-06
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