Extensions for Using Data Elements from FHIR R4 in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4 in FHIR STU3
0.1.0 - STU
Extensions for Using Data Elements from FHIR R4 in FHIR STU3 - Downloaded Version null See the Directory of published versions
| Page standards status: Trial-use | Maturity Level: 0 |
XML representation of the profile-ResearchStudy resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="profile-ResearchStudy"/>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition profile-ResearchStudy</b></p><a name="profile-ResearchStudy"> </a><a name="hcprofile-ResearchStudy"> </a><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 : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" 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 : var(--ig-left,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-profile-ResearchStudy-definitions.html#ResearchStudy">ResearchStudy</a><a name="ResearchStudy"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,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 : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/researchstudy.html">ResearchStudy</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension">Slices for extension</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/STU3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:primaryPurposeType" title="Extension URL = http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType">extension:primaryPurposeType</a><a name="ResearchStudy.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R4-ResearchStudy.primaryPurposeType.html">http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R4-research-study-prim-purp-type-for-R3.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R4-research-study-prim-purp-type-for-R3" class="binding">R4ResearchStudyPrimPurpTypeForR3 (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/STU3/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated. If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">Codes for the main intent of the study.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:phase" title="Extension URL = http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.phase">extension:phase</a><a name="ResearchStudy.extension.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R4-ResearchStudy.phase.html">http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.phase</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R4-research-study-phase-for-R3.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R4-research-study-phase-for-R3" class="binding">R4ResearchStudyPhaseForR3 (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/STU3/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included." class="binding">example</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:condition" title="Extension URL = http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.condition">extension:condition</a><a name="ResearchStudy.extension.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: Condition being studied (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R4-ResearchStudy.condition.html">http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.condition</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:objective" title="Extension URL = http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.objective">extension:objective</a><a name="ResearchStudy.extension.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: A goal for the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R4-ResearchStudy.objective.html">http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.objective</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.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: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status">status</a><a name="ResearchStudy.status"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status.extension">Slices for extension</a><a name="ResearchStudy.status.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/STU3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status.extension:status" title="Extension URL = http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.status">extension:status</a><a name="ResearchStudy.status.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/STU3/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: 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<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R4-ResearchStudy.status.html">http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.status</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R4-research-study-status-for-R3.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R4-research-study-status-for-R3" class="binding">R4ResearchStudyStatusForR3 (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/STU3/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">Codes that convey the current status of the research study.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.principalInvestigator">principalInvestigator</a><a name="ResearchStudy.principalInvestigator"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck003.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.principalInvestigator.extension">Slices for extension</a><a name="ResearchStudy.principalInvestigator.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/STU3/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0024.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.principalInvestigator.extension:principalInvestigator" title="Slice principalInvestigator: R4: `ResearchStudy.principalInvestigator` additional types from child elements (display, identifier, reference, type)">extension:principalInvestigator</a><a name="ResearchStudy.principalInvestigator.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">?gen-e1? [CanonicalType[http://hl7.org/fhir/StructureDefinition/alternate-reference]]</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R4: Researcher who oversees multiple aspects of the study additional types<br/><span style="font-weight:bold">URL: </span>http://hl7.org/fhir/StructureDefinition/alternate-reference<br/></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
<valueCode value="fhir"/>
</extension>
<extension url="http://hl7.org/fhir/StructureDefinition/package-source">
<extension url="packageId">
<valueId value="hl7.fhir.uv.xver-r4.r3"/>
</extension>
<extension url="version">
<valueString value="0.1.0"/>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
<valueInteger value="0">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueUri
value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4.r3"/>
</extension>
</valueInteger>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
<valueCode value="trial-use">
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
<valueUri
value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r4.r3"/>
</extension>
</valueCode>
</extension>
<url
value="http://hl7.org/fhir/4.0/StructureDefinition/profile-ResearchStudy"/>
<version value="0.1.0"/>
<name value="Profile_R4_ResearchStudy_R3"/>
<title
value="Cross-version Profile for R4.ResearchStudy for use in FHIR STU3"/>
<status value="active"/>
<experimental value="false"/>
<date value="2026-03-17T16:03:29.8292047-05:00"/>
<publisher value="FHIR Infrastructure"/>
<contact>
<name value="FHIR Infrastructure"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/fiwg"/>
</telecom>
</contact>
<description
value="This cross-version profile allows R4 ResearchStudy content to be represented via FHIR STU3 ResearchStudy resources."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<fhirVersion value="3.0.2"/>
<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="w5"/>
<uri value="http://hl7.org/fhir/w5"/>
<name value="W5 Mapping"/>
</mapping>
<mapping>
<identity value="clinicaltrials-gov"/>
<uri value="http://clinicaltrials.gov"/>
<name value="ClinicalTrials.gov 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="Investigation to increase healthcare-related patient-independent knowledge"/>
<definition
value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects."/>
<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-1"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain any narrative"/>
<expression value="contained.text.empty()"/>
<xpath value="not(parent::f:contained and f:text)"/>
<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-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource"/>
<expression
value="contained.where(('#'+id in %resource.descendants().reference).not()).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))"/>
<source
value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="clinical.diagnostics"/>
</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>
<code value="id"/>
</type>
<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 may 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>
<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."/>
<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.
This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<isModifier value="true"/>
<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>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueReference>🔗
<reference
value="http://hl7.org/fhir/ValueSet/all-languages|3.0.2"/>
</valueReference>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<strength value="extensible"/>
<description value="A human language."/>
<valueSetReference>🔗
<reference value="http://hl7.org/fhir/ValueSet/languages|3.0.2"/>
</valueSetReference>
</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 may 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 in formation 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>
<condition value="dom-1"/>
<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."/>
<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>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.extension">
<path value="ResearchStudy.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
</element>
<element id="ResearchStudy.extension:primaryPurposeType">
<path value="ResearchStudy.extension"/>
<sliceName value="primaryPurposeType"/>
<short
value="R4: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)"/>
<definition
value="R4: `ResearchStudy.primaryPurposeType` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.primaryPurposeType` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.primaryPurposeType` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType|0.1.0"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() | (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"/>
</element>
<element id="ResearchStudy.extension:phase">
<path value="ResearchStudy.extension"/>
<sliceName value="phase"/>
<short
value="R4: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)"/>
<definition value="R4: `ResearchStudy.phase` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.phase` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.phase` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.phase|0.1.0"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() | (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"/>
</element>
<element id="ResearchStudy.extension:condition">
<path value="ResearchStudy.extension"/>
<sliceName value="condition"/>
<short value="R4: Condition being studied (new)"/>
<definition
value="R4: `ResearchStudy.condition` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.condition` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.condition` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.condition|0.1.0"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() | (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"/>
</element>
<element id="ResearchStudy.extension:objective">
<path value="ResearchStudy.extension"/>
<sliceName value="objective"/>
<short value="R4: A goal for the study (new)"/>
<definition
value="R4: `ResearchStudy.objective` (new:BackboneElement)"/>
<comment
value="Element `ResearchStudy.objective` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.objective` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.objective|0.1.0"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() | (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"/>
</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. Usually modifier elements provide negation or qualification. In order 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."/>
<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.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<isModifier value="true"/>
<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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Organization's Unique Protocol ID; Secondary IDs"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="id"/>
</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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Brief Title"/>
</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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Interventions; Arm/Intervention Cross-Reference"/>
</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>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map
value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchStudy.status">
<path value="ResearchStudy.status"/>
<short
value="draft | in-progress | suspended | stopped | completed | entered-in-error"/>
<definition value="The current state of the study."/>
<comment
value="This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchStudy.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<isModifier value="true"/>
<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"/>
<valueSetReference>🔗
<reference
value="http://hl7.org/fhir/ValueSet/research-study-status|3.0.2"/>
</valueSetReference>
</binding>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="status"/>
</mapping>
</element>
<element id="ResearchStudy.status.id">
<path value="ResearchStudy.status.id"/>
<representation value="xmlAttr"/>
<short value="xml:id (or equivalent in JSON)"/>
<definition
value="unique id for the element within a resource (for internal references)"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
</element>
<element id="ResearchStudy.status.extension">
<path value="ResearchStudy.status.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
</element>
<element id="ResearchStudy.status.extension:status">
<path value="ResearchStudy.status.extension"/>
<sliceName value="status"/>
<short
value="R4: 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="R4: `ResearchStudy.status`"/>
<comment
value="Element `ResearchStudy.status` is mapped to FHIR STU3 element `ResearchStudy.status` as `SourceIsBroaderThanTarget`.
The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"/>
</type>
<condition value="ele-1"/>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression
value="hasValue() | (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"/>
</element>
<element id="ResearchStudy.status.value">
<path value="ResearchStudy.status.value"/>
<representation value="xmlAttr"/>
<short value="Primitive value for code"/>
<definition value="Primitive value for code"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="string.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-regex">
<valueString value="[^\s]+([\s]?[^\s]+)*"/>
</extension>
<code>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-json-type">
<valueString value="string"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-xml-type">
<valueString value="xsd:token"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-rdf-type">
<valueString value="xsd:token"/>
</extension>
</code>
</type>
</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>
<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; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
</mapping>
</element>
<element id="ResearchStudy.focus">
<path value="ResearchStudy.focus"/>
<short value="Drugs, devices, conditions, etc. under study"/>
<definition
value="The condition(s), 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>
<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, conditions and other interventions"/>
</binding>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Conditions or Focus of Study"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="what"/>
</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>
<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>
</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>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Citations, Links, Available Study Data/Documents"/>
</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>
<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>
</element>
<element id="ResearchStudy.jurisdiction">
<path value="ResearchStudy.jurisdiction"/>
<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.jurisdiction"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Jurisdiction"/>
</extension>
<strength value="extensible"/>
<description
value="Countries and regions within which this artifact is targeted for use"/>
<valueSetReference>🔗
<reference value="http://hl7.org/fhir/ValueSet/jurisdiction|3.0.2"/>
</valueSetReference>
</binding>
</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>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Detailed Description"/>
</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/StructureDefinition/Group"/>
</type>
<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="who.focus"/>
</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."/>
<requirements
value="[The list of types may be constrained as appropriate for the type of event]."/>
<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>
<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="when.done"/>
</mapping>
</element>
<element id="ResearchStudy.sponsor">
<path value="ResearchStudy.sponsor"/>
<short value="Organization responsible for the study"/>
<definition
value="The organization responsible for the execution of 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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Sponsor"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="who.actor"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator">
<path value="ResearchStudy.principalInvestigator"/>
<short value="The individual responsible for the study"/>
<definition
value="Indicates the individual who has primary oversite of the execution of the study."/>
<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"/>
</type>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Principal Investigator"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="who.actor"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator.id">
<path value="ResearchStudy.principalInvestigator.id"/>
<representation value="xmlAttr"/>
<short value="xml:id (or equivalent in JSON)"/>
<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>
<code value="string"/>
</type>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator.extension">
<path value="ResearchStudy.principalInvestigator.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<short value="Extension"/>
<definition value="An Extension"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
</element>
<element
id="ResearchStudy.principalInvestigator.extension:principalInvestigator">
<path value="ResearchStudy.principalInvestigator.extension"/>
<sliceName value="principalInvestigator"/>
<short
value="R4: Researcher who oversees multiple aspects of the study additional types"/>
<definition
value="R4: `ResearchStudy.principalInvestigator` additional types from child elements (display, identifier, reference, type)"/>
<comment
value="Element `ResearchStudy.principalInvestigator` is mapped to FHIR STU3 element `ResearchStudy.principalInvestigator` as `SourceIsBroaderThanTarget`.
The mappings for `ResearchStudy.principalInvestigator` do not cover the following types based on type expansion: display, identifier, reference, type.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R4 element `ResearchStudy.principalInvestigator` with unmapped reference targets: PractitionerRole."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/StructureDefinition/alternate-reference"/>
</type>
</element>
<element id="ResearchStudy.principalInvestigator.reference">
<path value="ResearchStudy.principalInvestigator.reference"/>
<short value="Literal reference, Relative, internal or absolute URL"/>
<definition
value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources."/>
<comment
value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Reference.reference"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<condition value="ref-1"/>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator.identifier">
<path value="ResearchStudy.principalInvestigator.identifier"/>
<short value="Logical reference, when literal reference is not known"/>
<definition
value="An identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference."/>
<comment
value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.
When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference
Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Reference.identifier"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Identifier"/>
</type>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchStudy.principalInvestigator.display">
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
<valueBoolean value="true"/>
</extension>
<path value="ResearchStudy.principalInvestigator.display"/>
<short value="Text alternative for the resource"/>
<definition
value="Plain text narrative that identifies the resource in addition to the resource reference."/>
<comment
value="This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Reference.display"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<isSummary value="true"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchStudy.site">
<path value="ResearchStudy.site"/>
<short value="Location involved in study execution"/>
<definition
value="Clinic, hospital or other healthcare location that is participating in the study."/>
<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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Facility"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="where"/>
</mapping>
</element>
<element id="ResearchStudy.reasonStopped">
<path value="ResearchStudy.reasonStopped"/>
<short value="Reason for terminating study early"/>
<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>
<isSummary value="true"/>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Why Study Stopped"/>
</mapping>
<mapping>
<identity value="w5"/>
<map value="why"/>
</mapping>
</element>
<element id="ResearchStudy.note">
<path value="ResearchStudy.note"/>
<short value="Comments made about the event"/>
<definition
value="Comments made about the event 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>
</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() | (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arms"/>
</mapping>
</element>
<element id="ResearchStudy.arm.id">
<path value="ResearchStudy.arm.id"/>
<representation value="xmlAttr"/>
<short value="xml:id (or equivalent in JSON)"/>
<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>
<code value="string"/>
</type>
<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. In order 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."/>
<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>
<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"/>
<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 that contains it. Usually modifier elements provide negation or qualification. In order 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."/>
<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"/>
<alias value="modifiers"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="BackboneElement.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<isModifier value="true"/>
<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>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Label"/>
</mapping>
</element>
<element id="ResearchStudy.arm.code">
<path value="ResearchStudy.arm.code"/>
<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.code"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Type"/>
</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>
<mapping>
<identity value="clinicaltrials-gov"/>
<map value="Arm Description"/>
</mapping>
</element>
</snapshot>
<differential>
<element id="ResearchStudy">
<path value="ResearchStudy"/>
</element>
<element id="ResearchStudy.extension">
<path value="ResearchStudy.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="0"/>
<max value="*"/>
</element>
<element id="ResearchStudy.extension:primaryPurposeType">
<path value="ResearchStudy.extension"/>
<sliceName value="primaryPurposeType"/>
<short
value="R4: treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility (new)"/>
<definition
value="R4: `ResearchStudy.primaryPurposeType` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.primaryPurposeType` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.primaryPurposeType` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.primaryPurposeType|0.1.0"/>
</type>
</element>
<element id="ResearchStudy.extension:phase">
<path value="ResearchStudy.extension"/>
<sliceName value="phase"/>
<short
value="R4: n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 (new)"/>
<definition value="R4: `ResearchStudy.phase` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.phase` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.phase` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.phase|0.1.0"/>
</type>
</element>
<element id="ResearchStudy.extension:condition">
<path value="ResearchStudy.extension"/>
<sliceName value="condition"/>
<short value="R4: Condition being studied (new)"/>
<definition
value="R4: `ResearchStudy.condition` (new:CodeableConcept)"/>
<comment
value="Element `ResearchStudy.condition` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.condition` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.condition|0.1.0"/>
</type>
</element>
<element id="ResearchStudy.extension:objective">
<path value="ResearchStudy.extension"/>
<sliceName value="objective"/>
<short value="R4: A goal for the study (new)"/>
<definition
value="R4: `ResearchStudy.objective` (new:BackboneElement)"/>
<comment
value="Element `ResearchStudy.objective` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.objective` has no mapping targets in FHIR STU3. Typically, this is because the element has been added (is a new element)."/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.objective|0.1.0"/>
</type>
</element>
<element id="ResearchStudy.status.extension">
<path value="ResearchStudy.status.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="0"/>
<max value="*"/>
</element>
<element id="ResearchStudy.status.extension:status">
<path value="ResearchStudy.status.extension"/>
<sliceName value="status"/>
<short
value="R4: 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="R4: `ResearchStudy.status`"/>
<comment
value="Element `ResearchStudy.status` is mapped to FHIR STU3 element `ResearchStudy.status` as `SourceIsBroaderThanTarget`.
The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/4.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"/>
</type>
</element>
<element id="ResearchStudy.principalInvestigator.extension">
<path value="ResearchStudy.principalInvestigator.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<ordered value="false"/>
<rules value="open"/>
</slicing>
<min value="0"/>
<max value="*"/>
</element>
<element
id="ResearchStudy.principalInvestigator.extension:principalInvestigator">
<path value="ResearchStudy.principalInvestigator.extension"/>
<sliceName value="principalInvestigator"/>
<short
value="R4: Researcher who oversees multiple aspects of the study additional types"/>
<definition
value="R4: `ResearchStudy.principalInvestigator` additional types from child elements (display, identifier, reference, type)"/>
<comment
value="Element `ResearchStudy.principalInvestigator` is mapped to FHIR STU3 element `ResearchStudy.principalInvestigator` as `SourceIsBroaderThanTarget`.
The mappings for `ResearchStudy.principalInvestigator` do not cover the following types based on type expansion: display, identifier, reference, type.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R4 element `ResearchStudy.principalInvestigator` with unmapped reference targets: PractitionerRole."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
<profile
value="http://hl7.org/fhir/StructureDefinition/alternate-reference"/>
</type>
</element>
</differential>
</StructureDefinition>
IG © 2025+ FHIR Infrastructure. Package hl7.fhir.uv.xver-r4.r3#0.1.0 based on FHIR 3.0.2. Generated 2026-03-20
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