R4 Ballot #1 (Mixed Normative/Trial use)
AdministrationThis page is part of the FHIR Specification (v3.3.0: R4 Ballot 2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Patient |
StructureDefinition for researchsubject
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="ResearchSubject"/> <meta> <lastUpdated value="2018-04-03T12:05:46.262+10:00"/> </meta> <text> <status value="generated"/> <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 class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="formats.html#table" title="The logical name of the element">Name</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="formats.html#table" title="Information about the use of the element">Flags</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="formats.html#table" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a> </th> <th class="hierarchy" style="width: 100px"> <a href="formats.html#table" title="Reference to the type of the element">Type</a> </th> <th class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="formats.html#table" title="Additional information about the element">Description & Constraints</a> <span style="float: right"> <a href="formats.html#table" title="Legend for this format"> <img alt="doco" src="help16.png" style="background-color: inherit"/> </a> </span> </th> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABGdBTUEAAK/INwWK6QAAABl0RVh0U 29mdHdhcmUAQWRvYmUgSW1hZ2VSZWFkeXHJZTwAAAJBSURBVDjLhdKxa5NBGMfx713yvkmbJnaoFiSF4mJTh06Kg4OgiyCCRXCof4 YIdXdxFhQVHPo3OFSoUx0FySQttaVKYq2NbdO8ed/L3fM4JG3tYPvAcfBw9+HHPWdUlf/V0tLSqKo+EpEHInJFRIohhDUR+RBCeDM 7O7ua55QSkRfVanVufHyckZERrLV0Op2Zra2tmXq9fg+YsmcAdyYnJykUCke9OI6ZmJgghHAZ4KwE3ntPs9mkVCohIjQaDWq1GiEE AM5KoHEcY62lVCrRarUoFotUKpUjIL/y/uqXYmV62ph/LSVrr30P4bEFcM4B0Ov1jk547/uAUTs1ceNdZIwB7V/GGHz6+9LXxY96e DiEgHMOY8xJAK8p4grZz5cElwNbwZgyxYu3EFM01lriOCZJEqIoIooiALIsGwA9Y1UcwcWoKNLdpLu9zvbnBWqNBhuvn5EDUmB0EH /1E2TZw5U+YLQovkun+Ytsaw1xCbnCOap334LC7s4Oe/ttvA+ICLmhMXRxDufczUECS37oAuevPwUEVFFp4/eXkXSdYc2IopSepnj tUh5/wg9gfn6+OQBUNaRIUkfDHhraSLoBKqikIF3yHJDLHaAkFOLciVHnyVAVj/S2Ub/XRyQD9aAZKgkaOohvo6ENgykcA07VEFDf Qv1uf4W9Y8y30bCPhg4qKZJtMnjTPqBO/vhkZ7h3EJeRslWNQMqgY2jIAIfa/m5sIKSpqpPsGEiz599e3b+GchtD+bSvjQJm2SG6c Nj6C+QmaxAek5tyAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Resource"/> <span title="ResearchSubject : A physical entity which is the primary unit of operational and/or administrative interest in a study.">ResearchSubject</span> <a name="ResearchSubject"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #efefef" title="Ballot Status = Draft">D</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="domainresource.html">DomainResource</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Physical entity which is the primary unit of interest in the study <br/> Elements defined in Ancestors: <a href="resource.html#Resource" title="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.">id</a> , <a href="resource.html#Resource" title="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.">meta</a> , <a href="resource.html#Resource" title="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.">implicitRules</a> , <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , <a href="domainresource.html#DomainResource" title="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.">text</a> , <a href="domainresource.html#DomainResource" title="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.">contained</a> , <a href="domainresource.html#DomainResource" title="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.">extension</a> , <a href="domainresource.html#DomainResource" title="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. 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.">modifierExtension</a> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,R0lGODlhEAAQAOZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQk ad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRP z58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPv szv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866O UPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6i f3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///////yH5BAEAAH8ALAAAAAAQABAAAAfNgH+Cg36FfoOIhH4JBxBghYl/hQ kNAV0IVT5GkJKLCwtQaSsSdx9aR26Gcwt2IkQaNRI6dBERIzCFDSgWSW8WCDkbBnoOQ3uFARc/JQJfCAZlT0x4ZFyFBxdNQT9ZCBN WKQoKUQ+FEDgcdTIAV14YDmg2CgSFA0hmQC5TLE4VRTdrKJAoxOeFCzZSwsw4U6BCizwUQhQyEaAPiAwCVNCY0FCNnA6GPAwYoETI FgY9loiRA4dToTYnsOxg8CBGHE6ICvEYQ4AKzkidfgoKBAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.identifier : Identifiers assigned to this research subject for a study.">identifier</span> <a name="ResearchSubject.identifier"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Identifier">Identifier</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Business Identifier for research subject in a study <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: 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title="Primitive Data Type"/> <span title="ResearchSubject.status : The current state of the subject.">status</span> <a name="ResearchSubject.status"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is a modifier element">?!</a> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#code">code</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn <br/> <a href="valueset-research-subject-status.html" title="Indicates the progression of a study subject through a study">ResearchSubjectStatus</a> ( <a href="terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set">Required</a> ) </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,R0lGODlhEAAQAOZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQk ad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRP z58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPv szv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866O UPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6i f3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///////yH5BAEAAH8ALAAAAAAQABAAAAfNgH+Cg36FfoOIhH4JBxBghYl/hQ kNAV0IVT5GkJKLCwtQaSsSdx9aR26Gcwt2IkQaNRI6dBERIzCFDSgWSW8WCDkbBnoOQ3uFARc/JQJfCAZlT0x4ZFyFBxdNQT9ZCBN WKQoKUQ+FEDgcdTIAV14YDmg2CgSFA0hmQC5TLE4VRTdrKJAoxOeFCzZSwsw4U6BCizwUQhQyEaAPiAwCVNCY0FCNnA6GPAwYoETI FgY9loiRA4dToTYnsOxg8CBGHE6ICvEYQ4AKzkidfgoKBAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchSubject.period : The dates the subject began and ended their participation in the study.">period</span> <a name="ResearchSubject.period"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#Period">Period</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Start and end of participation</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.study : Reference to the study the subject is participating in.">study</span> <a name="ResearchSubject.study"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html">Reference</a> ( <a href="researchstudy.html">ResearchStudy</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Study subject is part of</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.individual : The record of the person or animal who is involved in the study.">individual</span> <a name="ResearchSubject.individual"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; background-color: white" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html">Reference</a> ( <a href="patient.html">Patient</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Who is part of study</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIW XMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3gYBFzI0BrFQCwAAAERJREFUOMtj/P//PwMlgImBQjDwBrCcOnWKokBgYWBgYDCU+06W5i 8MUggvnH/EOVJjAW4AuQHJ+O75LYqikXE0LzAAALePEntTkEoSAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.assignedArm : The name of the arm in the study the subject is expected to follow as part of this study.">assignedArm</span> <a name="ResearchSubject.assignedArm"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#string">string</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">What path should be followed</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgC sPVYVAgIJrA/sAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav 7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIW XMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3gYBFzI0BrFQCwAAAERJREFUOMtj/P//PwMlgImBQjDwBrCcOnWKokBgYWBgYDCU+06W5i 8MUggvnH/EOVJjAW4AuQHJ+O75LYqikXE0LzAAALePEntTkEoSAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchSubject.actualArm : The name of the arm in the study the subject actually followed as part of this study.">actualArm</span> <a name="ResearchSubject.actualArm"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#string">string</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">What path was followed</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;"> <td class="hierarchy" 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(data: image/png;base64,iVBORw0KG goAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAI0lEQVR42u3QIQEAAAACIL/6/4MvTAQOkLYBAAB4kAAAANwMad9AqkRjgNAAAA AASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAw NdCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB 3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUO L+O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchSubject.consent : A record of the patient's informed agreement to participate in the study.">consent</span> <a name="ResearchSubject.consent"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html">Reference</a> ( <a href="consent.html">Consent</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Agreement to participate in study</td> </tr> <tr> <td class="hierarchy" colspan="5"> <br/> <a href="formats.html#table" title="Legend for this format"> <img alt="doco" src="help16.png" style="background-color: inherit"/> Documentation for this format </a> </td> </tr> </table> </div> </text> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-ballot-status"> <valueString value="Draft"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="0"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/> <name value="ResearchSubject"/> <status value="draft"/> <date value="2018-04-03T12:05:46+10:00"/> <publisher value="Health Level Seven International (Biomedical Research and Regulation)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim/index.cfm"/> </telecom> </contact> <description value="A physical entity which is the primary unit of operational and/or administrative interest in a study."/> <fhirVersion value="3.3.0"/> <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/fivews"/> <name value="FiveWs Pattern"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="ResearchSubject"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> <derivation value="specialization"/> <snapshot> <element id="ResearchSubject"> <path value="ResearchSubject"/> <short value="Physical entity which is the primary unit of interest in the study"/> <definition value="A physical entity which is the primary unit of operational and/or administrative interest in a study."/> <comment value="Need to make sure we encompass public health studies."/> <alias value="Study Subject"/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject"/> <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="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="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="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.all(('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical)) ) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists())"/> <xpath value="not(exists(for $contained in f:contained return $contained[not(parent::*/descendant::f:reference/@va lue=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/> <source value="DomainResource"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <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> </element> <element id="ResearchSubject.id"> <path value="ResearchSubject.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> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.meta"> <path value="ResearchSubject.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> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.implicitRules"> <path value="ResearchSubject.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> <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="ResearchSubject.language"> <path value="ResearchSubject.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> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueReference> <reference value="http://hl7.org/fhir/ValueSet/all-languages"/> </valueReference> </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="extensible"/> <description value="A human language."/> <valueSetCanonical value="http://hl7.org/fhir/ValueSet/languages"/> </binding> </element> <element id="ResearchSubject.text"> <path value="ResearchSubject.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 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"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="ResearchSubject.contained"> <path value="ResearchSubject.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> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.extension"> <path value="ResearchSubject.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> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.modifierExtension"> <path value="ResearchSubject.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. 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"/> <isModifierReason value="Not known why this is labelled a modifier"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchSubject.identifier"> <path value="ResearchSubject.identifier"/> <short value="Business Identifier for research subject in a study"/> <definition value="Identifiers assigned to this research subject for a study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchSubject.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchSubject.status"> <path value="ResearchSubject.status"/> <short value="candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn"/> <definition value="The current state of the subject."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <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="ResearchSubjectStatus"/> </extension> <strength value="required"/> <description value="Indicates the progression of a study subject through a study"/> <valueSetCanonical value="http://hl7.org/fhir/ValueSet/research-subject-status"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.period"> <path value="ResearchSubject.period"/> <short value="Start and end of participation"/> <definition value="The dates the subject began and ended their participation in the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.planned"/> </mapping> </element> <element id="ResearchSubject.study"> <path value="ResearchSubject.study"/> <short value="Study subject is part of"/> <definition value="Reference to the study the subject is participating in."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.study"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.individual"> <path value="ResearchSubject.individual"/> <short value="Who is part of study"/> <definition value="The record of the person or animal who is involved in the study."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchSubject.individual"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> </type> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchSubject.assignedArm"> <path value="ResearchSubject.assignedArm"/> <short value="What path should be followed"/> <definition value="The name of the arm in the study the subject is expected to follow as part of this study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.assignedArm"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.actualArm"> <path value="ResearchSubject.actualArm"/> <short value="What path was followed"/> <definition value="The name of the arm in the study the subject actually followed as part of this study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.actualArm"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="ResearchSubject.consent"> <path value="ResearchSubject.consent"/> <short value="Agreement to participate in study"/> <definition value="A record of the patient's informed agreement to participate in the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchSubject.consent"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent"/> </type> <isModifier value="false"/> <isSummary value="false"/> </element> </snapshot> <differential> <element id="ResearchSubject"> <path value="ResearchSubject"/> <short value="Physical entity which is the primary unit of interest in the study"/> <definition value="A physical entity which is the primary unit of operational and/or administrative interest in a study."/> <comment value="Need to make sure we encompass public health studies."/> <alias value="Study Subject"/> <min value="0"/> <max value="*"/> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> <mapping> <identity value="rim"/> <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> </mapping> </element> <element id="ResearchSubject.identifier"> <path value="ResearchSubject.identifier"/> <short value="Business Identifier for research subject in a study"/> <definition value="Identifiers assigned to this research subject for a study."/> <min value="0"/> <max value="*"/> <type> <code value="Identifier"/> </type> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchSubject.status"> <path value="ResearchSubject.status"/> <short value="candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn"/> <definition value="The current state of the subject."/> <min value="1"/> <max value="1"/> <type> <code value="code"/> </type> <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="ResearchSubjectStatus"/> </extension> <strength value="required"/> <description value="Indicates the progression of a study subject through a study"/> <valueSetCanonical value="http://hl7.org/fhir/ValueSet/research-subject-status"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchSubject.period"> <path value="ResearchSubject.period"/> <short value="Start and end of participation"/> <definition value="The dates the subject began and ended their participation in the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <type> <code value="Period"/> </type> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.planned"/> </mapping> </element> <element id="ResearchSubject.study"> <path value="ResearchSubject.study"/> <short value="Study subject is part of"/> <definition value="Reference to the study the subject is participating in."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <isSummary value="true"/> </element> <element id="ResearchSubject.individual"> <path value="ResearchSubject.individual"/> <short value="Who is part of study"/> <definition value="The record of the person or animal who is involved in the study."/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> </type> <isSummary value="true"/> </element> <element id="ResearchSubject.assignedArm"> <path value="ResearchSubject.assignedArm"/> <short value="What path should be followed"/> <definition value="The name of the arm in the study the subject is expected to follow as part of this study."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> </element> <element id="ResearchSubject.actualArm"> <path value="ResearchSubject.actualArm"/> <short value="What path was followed"/> <definition value="The name of the arm in the study the subject actually followed as part of this study."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> </element> <element id="ResearchSubject.consent"> <path value="ResearchSubject.consent"/> <short value="Agreement to participate in study"/> <definition value="A record of the patient's informed agreement to participate in the study."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent"/> </type> </element> </differential> </StructureDefinition>
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
®© HL7.org 2011+. FHIR Mixed Nomative/Trial Use Ballot (v3.3.0-13671) generated on Tue, Apr 3, 2018 12:17+1000. QA Page
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