FHIR Release 3 (STU)
AdministrationThis page is part of the FHIR Specification (v3.0.2: STU 3). 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
| Regulated Clinical Research Information Management Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Practitioner |
StructureDefinition for researchstudy
<StructureDefinition xmlns="http://hl7.org/fhir"> <id value="ResearchStudy"/> <meta> <lastUpdated value="2019-10-24T11:53:00+11:00"/> </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="ResearchStudy : 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.">ResearchStudy</span> <a name="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"/> <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">Investigation to increase healthcare-related patient-independent knowledge <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 may 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.">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 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.">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. 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.">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. 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.">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="ResearchStudy.identifier : Identifiers assigned to this research study by the sponsor or other systems.">identifier</span> <a name="ResearchStudy.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"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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 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: 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="ResearchStudy.title : A short, descriptive user-friendly label for the study.">title</span> <a name="ResearchStudy.title"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#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">Name for this 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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.protocol : The set of steps expected to be performed as part of the execution of the study.">protocol</span> <a name="ResearchStudy.protocol"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="references.html">Reference</a> ( <a href="plandefinition.html">PlanDefinition</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Steps followed in executing 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: 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="ResearchStudy.partOf : A larger research study of which this particular study is a component or step.">partOf</span> <a name="ResearchStudy.partOf"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="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">Part of larger 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: 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="ResearchStudy.status : The current state of the study.">status</span> <a name="ResearchStudy.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"> <span style="padding: 3px" title="This element is a modifier element">?!</span> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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">draft | in-progress | suspended | stopped | completed | entered-in-error <br/> <a href="valueset-research-study-status.html" title="Codes that convey the current status of the research study">ResearchStudyStatus</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="ResearchStudy.category : Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.">category</span> <a name="ResearchStudy.category"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Classifications for the 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: 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="ResearchStudy.focus : 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.">focus</span> <a name="ResearchStudy.focus"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Drugs, devices, conditions, etc. under 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: 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="ResearchStudy.contact : Contact details to assist a user in learning more about or engaging with the study.">contact</span> <a name="ResearchStudy.contact"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="metadatatypes.html#ContactDetail">ContactDetail</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Contact details for the 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: 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="ResearchStudy.relatedArtifact : Citations, references and other related documents.">relatedArtifact</span> <a name="ResearchStudy.relatedArtifact"> </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..*</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="metadatatypes.html#RelatedArtifact">RelatedArtifact</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">References and dependencies <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: 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="ResearchStudy.keyword : Key terms to aid in searching for or filtering the study.">keyword</span> <a name="ResearchStudy.keyword"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Used to search for the 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: 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="ResearchStudy.jurisdiction : Indicates a country, state or other region where the study is taking place.">jurisdiction</span> <a name="ResearchStudy.jurisdiction"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Geographic region(s) for study <br/> <a href="valueset-jurisdiction.html" title="Countries and regions within which this artifact is targeted for use">Jurisdiction ValueSet</a> ( <a href="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.">Extensible</a> ) <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: 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="ResearchStudy.description : A full description of how the study is being conducted.">description</span> <a name="ResearchStudy.description"> </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#markdown">markdown</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 this is study doing</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="ResearchStudy.enrollment : 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".">enrollment</span> <a name="ResearchStudy.enrollment"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="references.html">Reference</a> ( <a href="group.html">Group</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Inclusion & exclusion criteria <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: 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="ResearchStudy.period : Identifies the start date and the expected (or actual, depending on status) end date for the study.">period</span> <a name="ResearchStudy.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"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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">When the study began and ended</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="ResearchStudy.sponsor : The organization responsible for the execution of the study.">sponsor</span> <a name="ResearchStudy.sponsor"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="references.html">Reference</a> ( <a href="organization.html">Organization</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Organization responsible for the 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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.principalInvestigator : Indicates the individual who has primary oversite of the execution of the study.">principalInvestigator</span> <a name="ResearchStudy.principalInvestigator"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="references.html">Reference</a> ( <a href="practitioner.html">Practitioner</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">The individual responsible for the 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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxj wv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjE EOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQ KlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.site : Clinic, hospital or other healthcare location that is participating in the study.">site</span> <a name="ResearchStudy.site"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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="references.html">Reference</a> ( <a href="location.html">Location</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Location involved in study execution <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: 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="ResearchStudy.reasonStopped : A description and/or code explaining the premature termination of the study.">reasonStopped</span> <a name="ResearchStudy.reasonStopped"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <span style="padding: 3px" title="This element is included in summaries">Σ</span> </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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Reason for terminating study early</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="ResearchStudy.note : Comments made about the event by the performer, subject or other participants.">note</span> <a name="ResearchStudy.note"> </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..*</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#Annotation">Annotation</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Comments made about the event <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/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,R0lGODlhEAAQAMQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw /npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///////yH5BAEAAB8ALAAAAAAQABAAAAV24CeOZG mepqeqqOgxjBZFa+19r4ftWQUAgqDgltthMshMIJAZ4jYDHsBARSAmFOJvq+g6HIdEFgcYmBWNxoNAsDjGHgBnmV5bCoUDHLBIq9s FEhIdcAYJdYASFRUQhQkLCwkOFwcdEBAXhVabE52ecDahKy0oIQA7" style="background-color: white; background-color: inherit" title="Element"/> <span title="ResearchStudy.arm : 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.">arm</span> <a name="ResearchStudy.arm"> </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..*</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="backboneelement.html">BackboneElement</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Defined path through the study for a subject <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/LjIAAAALElEQVR42u3QwQkAMAwDsezq/WdIO4XJQwa9DTdJpulv258AAMANIgAAADUPYA VAgAJ//usAAAAASUVORK5CYII=)"> <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 3RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiY FCMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=" 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="ResearchStudy.arm.name : Unique, human-readable label for this arm of the study.">name</span> <a name="ResearchStudy.arm.name"> </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">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#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">Label for study arm</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/LjIAAAALElEQVR42u3QwQkAMAwDsezq/WdIO4XJQwa9DTdJpulv258AAMANIgAAADUPYA VAgAJ//usAAAAASUVORK5CYII=)"> <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 3RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiY FCMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=" 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="ResearchStudy.arm.code : Categorization of study arm, e.g. experimental, active comparator, placebo comparater.">code</span> <a name="ResearchStudy.arm.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"/> <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#CodeableConcept">CodeableConcept</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Categorization of study arm</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 3RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiY FCMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=" 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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIW XMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3gYBFzI0BrFQCwAAAERJREFUOMtj/P//PwMlgImBQjDwBrCcOnWKokBgYWBgYDCU+06W5i 8MUggvnH/EOVJjAW4AuQHJ+O75LYqikXE0LzAAALePEntTkEoSAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchStudy.arm.description : A succinct description of the path through the study that would be followed by a subject adhering to this arm.">description</span> <a name="ResearchStudy.arm.description"> </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">Short explanation of study path</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-fmm"> <valueInteger value="0"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="rcrim"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> <name value="ResearchStudy"/> <status value="draft"/> <date value="2019-10-24T11:53:00+11:00"/> <publisher value="Health Level Seven International (Regulated Clinical Research Information Management)"/> <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="Base StructureDefinition for ResearchStudy Resource"/> <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/DomainResource"/> <derivation value="specialization"/> <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="*"/> <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"/> <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="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"/> </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."/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/languages"/> </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"/> <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. 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="DomainResource.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.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="*"/> <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"/> <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="*"/> <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="*"/> <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"/> <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"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> <mapping> <identity value="w5"/> <map value="status"/> </mapping> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category"/> <short value="Classifications for the study"/> <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/> <min value="0"/> <max value="*"/> <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="*"/> <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="*"/> <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="*"/> <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="*"/> <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="*"/> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="Countries and regions within which this artifact is targeted for use"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </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"/> <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="*"/> <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"/> <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"/> <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"/> <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.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="*"/> <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"/> <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="*"/> <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="*"/> <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="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"/> <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"/> <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"/> <type> <code value="string"/> </type> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Description"/> </mapping> </element> </snapshot> <differential> <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="*"/> <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.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="*"/> <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"/> <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="*"/> <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="*"/> <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"/> <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"/> </valueSetReference> </binding> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> <mapping> <identity value="w5"/> <map value="status"/> </mapping> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category"/> <short value="Classifications for the study"/> <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/> <min value="0"/> <max value="*"/> <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="*"/> <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="*"/> <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="*"/> <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="*"/> <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="*"/> <type> <code value="CodeableConcept"/> </type> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="Countries and regions within which this artifact is targeted for use"/> <valueSetReference> <reference value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </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"/> <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="*"/> <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"/> <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"/> <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"/> <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.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="*"/> <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"/> <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="*"/> <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="*"/> <type> <code value="BackboneElement"/> </type> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arms"/> </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"/> <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"/> <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"/> <type> <code value="string"/> </type> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Description"/> </mapping> </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.
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