Release 4B Ballot #1
AdministrationThis page is part of the FHIR Specification (v4.1.0: Release 4B Ballot #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions 
. Page versions: R5 R4B R4 R3
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Practitioner |
Raw XML (canonical form + also see XML Format Specification)
StructureDefinition for researchstudy
<?xml version="1.0" encoding="UTF-8"?> <StructureDefinition xmlns="http://hl7.org/fhir"> <id value="ResearchStudy"/> <meta> <lastUpdated value="2021-03-11T17:06:20.662+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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAACCE lEQVQ4y4XTv2sUQRTA8e9Mzt3kjoOLSXFgZ6GJQlALCysLC89OsLTXv0VFxE4stRAEQUghSWEXuM4qMZpATsUD70dyMdnduZ15z2I vMV5IfDDNm5nPm59GVTkpms1mTVXvhxDuichlEZn03m+KyJL3/mWj0fiKqp7YVlZWXrfbbR2PTqeji4uLn1WVEqdECKFRr9eP5Wdn Z/HeXwROB0TEA3S7XarVKiLC1tYW8/PzeO/5LxBCUABrLXEc02q1KJfLB30F0P144dPU9LVL1kwcrU06WP0ewhML4JwDYDgcHo7I8 7wAjNq5ypU3Z8arT8F5u/xejw52zmGM+Rcg1wyIcc/BTYCdBlODyh3ElA1AHMekaUoURURRBECWZSNgaGzBxxAU9jfQ9jrJr2dcbb XobRYHlQAzo9X1gDR9+KUArE6CwLefZD9WCW6P0uRZKreXqADkHXZ3dshzjwRholJH397AOXcTwHTfzQ1n7q6NnYEAy+DWQVNwKWQ J6vcx557Se7HAzIN1M9rCwVteA/rAYDRRICQgSZEr7WLYO3bzJVJGQBu0D74PkoHkoBnIHvjfkO9AGABmDHCjFWgH8i7kPQh9yEeY H4DfLhBJgA2A7BBQJ9uwXWY3rhJqFo1AaiB1CBngwKZQcqAeSFSduL9Akj7qPF64jnALS5VTPwdgPwwJ+uog9Qcx4kRZiPKqxgAAA ABJRU5ErkJggg==" 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"> <a href="versions.html#std-process" style="padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6" title="Standards Status = Trial Use">TU</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="domainresource.html">DomainResource</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">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 might not always be associated with version changes to the resource.">meta</a> , <a href="resource.html#Resource" title="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.">implicitRules</a> , <a href="resource.html#Resource" title="The base language in which the resource is written.">language</a> , <a href="domainresource.html#DomainResource" title="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.">text</a> , <a href="domainresource.html#DomainResource" title="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.">contained</a> , <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.">extension</a> , <a href="domainresource.html#DomainResource" title="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).">modifierExtension</a> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" 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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="plandefinition.html">PlanDefinition</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" 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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="conformance-rules.html#isModifier" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</a> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">1..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc rual-and-intervention | withdrawn <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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.primaryPurposeType : The type of study based upon the intent of the study's activities. A classification of the intent of the study.">primaryPurposeType</span> <a name="ResearchStudy.primaryPurposeType"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#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">treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility <br/> <a href="valueset-research-study-prim-purp-type.html" title="Codes for the main intent of the study.">ResearchStudyPrimaryPurposeType</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> ) </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.phase : The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.">phase</span> <a name="ResearchStudy.phase"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 <br/> <a href="valueset-research-study-phase.html" title="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.">ResearchStudyPhase</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" 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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#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/> <span title="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc.">ResearchStudyCategory</span> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.focus : The 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Drugs, devices, etc. under study <br/> <span title="Codes for medications, devices and other interventions.">ResearchStudyFocus</span> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.condition : The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.">condition</span> <a name="ResearchStudy.condition"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#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">Condition being studied <br/> <a href="valueset-condition-code.html" title="Identification of the condition or diagnosis.">Condition/Problem/Diagnosis Codes</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</a> ) <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" 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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Used to search for the study <br/> <span title="Words associated with the study that may be useful in discovery.">ResearchStudyKeyword</span> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.location : Indicates a country, state or other region where the study is taking place.">location</span> <a name="ResearchStudy.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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="datatypes.html#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</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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" 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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.sponsor : An organization that initiates the investigation and is legally responsible for 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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">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 that initiates and is legally responsible for the study</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.principalInvestigator : A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.">principalInvestigator</span> <a name="ResearchStudy.principalInvestigator"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">Reference</a> ( <a href="practitioner.html">Practitioner</a> | <a href="practitionerrole.html">PractitionerRole</a> ) </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">Researcher who oversees multiple aspects of 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjw v8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEE OACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQK lQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC" style="background-color: white; background-color: inherit" title="Reference to another Resource"/> <span title="ResearchStudy.site : A facility in which study activities are conducted.">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"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="references.html#Reference">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">Facility where study activities are conducted <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"> <a href="elementdefinition-definitions.html#ElementDefinition.isSummary" style="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is included in summaries">Σ</a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close d-per-study-design <br/> <a href="valueset-research-study-reason-stopped.html" title="Codes for why the study ended prematurely.">ResearchStudyReasonStopped</a> ( <a href="terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set. The value set merely provides examples of the types of concepts intended to be included.">Example</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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: white; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.note : Comments made about the study 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 study <br/> </td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEA ADClAVWFQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw/ npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///wD/ACH5BAEKAB8ALAAAAAAQABAAAAVl4CeOZGm e5qCqqDg8jyVJaz1876DsmAQAgqDgltspMEhMJoMZ4iy6I1AooFCIv+wKybziALVAoAEjYLwDgGIpJhMslgxaLR4/3rMAWoBp32V5 exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==" style="background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAA AXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv +PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" 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: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA +NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv +PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.arm.type : Categorization of study arm, e.g. experimental, active comparator, placebo comparater.">type</span> <a name="ResearchStudy.arm.type"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVW FQIBRHMicAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv +PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL +O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" 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 style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30Cq ZFfFmwAAAABJRU5ErkJggg==)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL +O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw/ npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///wD/ACH5BAEKAB8ALAAAAAAQABAAAAVl4CeOZGm e5qCqqDg8jyVJaz1876DsmAQAgqDgltspMEhMJoMZ4iy6I1AooFCIv+wKybziALVAoAEjYLwDgGIpJhMslgxaLR4/3rMAWoBp32V5 exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==" style="background-color: #F7F7F7; background-color: inherit" title="Element"/> <span title="ResearchStudy.objective : A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.">objective</span> <a name="ResearchStudy.objective"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..*</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">A goal 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,iVBORw0KGg oAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALElEQVR4Xu3IsQ0AIAwEsez6+89AqKGGJj7JzVWS+mm3zgcAAMxwDQAAgFcaYAV AgNGLTjgAAAAASUVORK5CYII=)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiYF CMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7 /2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARk lEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvT RgwAAAABJRU5ErkJggg==" style="background-color: white; background-color: inherit" title="Primitive Data Type"/> <span title="ResearchStudy.objective.name : Unique, human-readable label for this objective of the study.">name</span> <a name="ResearchStudy.objective.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">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">Label for the objective</td> </tr> <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVB ORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoQ0AMAwEsez6+8/QBqe4IJJPMrlKUpt0Zz4AAGCHZwAA APxyAWqFQIAoZQ9kAAAAAElFTkSuQmCC)"> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwN dCABMPwMo2ctnoQAAAABJRU5ErkJggg==" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzIZgEiYEgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAIElEQVQ4y2P8//8/AyWAiYF CMGrAqAGjBowaMGoAAgAALL0DKYQ0DPIAAAAASUVORK5CYII=" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3 RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL +O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC" style="background-color: inherit"/> <img alt="." class="hierarchy" src="data:image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQka d4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz 58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvs zv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OU Pvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if 3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYw bdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSF VResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7" style="background-color: #F7F7F7; background-color: inherit" title="Data Type"/> <span title="ResearchStudy.objective.type : The kind of study objective.">type</span> <a name="ResearchStudy.objective.type"> </a> </td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px"/> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">0..1</td> <td class="hierarchy" style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px">primary | secondary | exploratory <br/> <a href="valueset-research-study-objective-type.html" title="Codes for the kind of study objective.">ResearchStudyObjectiveType</a> ( <a href="terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant.">Preferred</a> ) </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-category"> <valueString value="Specialized.Public Health &amp; Research"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"> <valueCode value="trial-use"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"> <valueInteger value="1"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category"> <valueCode value="business"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"> <valueCode value="brr"/> </extension> <url value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> <version value="4.1.0"/> <name value="ResearchStudy"/> <status value="draft"/> <date value="2021-03-11T17:06:20+11:00"/> <publisher value="Health Level Seven International (Biomedical Research and Regulation)"/> <contact> <telecom> <system value="url"/> <value value="http://hl7.org/fhir"/> </telecom> </contact> <contact> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim/index.cfm"/> </telecom> </contact> <fhirVersion value="4.1.0"/> <mapping> <identity value="BRIDG5.1"/> <uri value="https://bridgmodel.nci.nih.gov"/> <name value="BRIDG 5.1 Mapping"/> </mapping> <mapping> <identity value="v2"/> <uri value="http://hl7.org/v2"/> <name value="HL7 v2 Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern 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="*"/> <base> <path value="ResearchStudy"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/> <expression value="contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descenda nts().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()"/> <xpath value="not(exists(for $resource in . return (for $contained in $resource/f:contained return $contained[not( descendant::f:*/@value='#' or (exists(f:id) and $resource//f:*/@*=concat('#', $contained/*/f:id/@valu e)))])))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:security))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <xpath value="exists(f:text/h:div)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="ObservationalStudyProtocolVersion; Study; StudyProtocolVersion"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> <mapping> <identity value="rim"/> <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> </mapping> <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> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUri value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchStudy.meta"> <path value="ResearchStudy.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="ResearchStudy.implicitRules"> <path value="ResearchStudy.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/> <isSummary value="true"/> </element> <element id="ResearchStudy.language"> <path value="ResearchStudy.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="A human language."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="preferred"/> <description value="IETF language tag"/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </binding> </element> <element id="ResearchStudy.text"> <path value="ResearchStudy.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="ResearchStudy.contained"> <path value="ResearchStudy.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchStudy.extension"> <path value="ResearchStudy.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchStudy.modifierExtension"> <path value="ResearchStudy.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.ht ml#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchStudy.identifier"> <path value="ResearchStudy.identifier"/> <short value="Business Identifier for study"/> <definition value="Identifiers assigned to this research study by the sponsor or other systems."/> <requirements value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Organization's Unique Protocol ID; Secondary IDs"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchStudy.title"> <path value="ResearchStudy.title"/> <short value="Name for this study"/> <definition value="A short, descriptive user-friendly label for the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.title"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Brief Title"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/> </mapping> </element> <element id="ResearchStudy.protocol"> <path value="ResearchStudy.protocol"/> <short value="Steps followed in executing study"/> <definition value="The set of steps expected to be performed as part of the execution of the study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.protocol"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Interventions; Arm/Intervention Cross-Reference"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocumentVersionPublicTitle.name"/> </mapping> <mapping> <identity value="rim"/> <map value=".outboundRelationship[typeCode=DEFN].target"/> </mapping> </element> <element id="ResearchStudy.partOf"> <path value="ResearchStudy.partOf"/> <short value="Part of larger study"/> <definition value="A larger research study of which this particular study is a component or step."/> <requirements value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/> <alias value="container"/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.partOf"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="CompanionStudyRelationship"/> </mapping> <mapping> <identity value="rim"/> <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/> </mapping> </element> <element id="ResearchStudy.status"> <path value="ResearchStudy.status"/> <short value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc rual-and-intervention | withdrawn"/> <definition value="The current state of the study."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchStudy.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes that convey the current status of the research study."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyStatus"/> </extension> <strength value="required"/> <description value="Codes that convey the current status of the research study."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status|4.1.0"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyOverallStatus.code"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchStudy.primaryPurposeType"> <path value="ResearchStudy.primaryPurposeType"/> <short value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/> <definition value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.primaryPurposeType"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the main intent of the study."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyPrimaryPurposeType"/> </extension> <strength value="extensible"/> <description value="Codes for the main intent of the study."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.primaryPurposeTypeCode"/> </mapping> </element> <element id="ResearchStudy.phase"> <path value="ResearchStudy.phase"/> <short value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/> <definition value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.phase"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyPhase"/> </extension> <strength value="example"/> <description value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Phase"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.phaseCode"/> </mapping> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category"/> <short value="Classifications for the study"/> <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.category"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyCategory"/> </extension> <strength value="example"/> <description value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyP rotocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol. controlTypeCode"/> </mapping> </element> <element id="ResearchStudy.focus"> <path value="ResearchStudy.focus"/> <short value="Drugs, devices, etc. under study"/> <definition value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.focus"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for medications, devices and other interventions."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyFocus"/> </extension> <strength value="example"/> <description value="Codes for medications, devices and other interventions."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Focus of Study"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocol.interventionTypeCode"/> </mapping> </element> <element id="ResearchStudy.condition"> <path value="ResearchStudy.condition"/> <short value="Condition being studied"/> <definition value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.condition"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Identification of the condition or diagnosis."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ConditionCode"/> </extension> <strength value="example"/> <description value="Identification of the condition or diagnosis."/> <valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Conditions"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyCondition.code"/> </mapping> </element> <element id="ResearchStudy.contact"> <path value="ResearchStudy.contact"/> <short value="Contact details for the study"/> <definition value="Contact details to assist a user in learning more about or engaging with the study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.contact"/> <min value="0"/> <max value="*"/> </base> <type> <code value="ContactDetail"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVe rsion"/> </mapping> </element> <element id="ResearchStudy.relatedArtifact"> <path value="ResearchStudy.relatedArtifact"/> <short value="References and dependencies"/> <definition value="Citations, references and other related documents."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.relatedArtifact"/> <min value="0"/> <max value="*"/> </base> <type> <code value="RelatedArtifact"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Citations, Links, Available Study Data/Documents"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/> </mapping> </element> <element id="ResearchStudy.keyword"> <path value="ResearchStudy.keyword"/> <short value="Used to search for the study"/> <definition value="Key terms to aid in searching for or filtering the study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.keyword"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Words associated with the study that may be useful in discovery."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyKeyword"/> </extension> <strength value="example"/> <description value="Words associated with the study that may be useful in discovery."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Keywords"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/> </mapping> </element> <element id="ResearchStudy.location"> <path value="ResearchStudy.location"/> <short value="Geographic region(s) for study"/> <definition value="Indicates a country, state or other region where the study is taking place."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.location"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Countries and regions within which this artifact is targeted for use."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="Countries and regions within which this artifact is targeted for use."/> <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.participatingLocationCode"/> </mapping> </element> <element id="ResearchStudy.description"> <path value="ResearchStudy.description"/> <short value="What this is study doing"/> <definition value="A full description of how the study is being conducted."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.description"/> <min value="0"/> <max value="1"/> </base> <type> <code value="markdown"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Detailed Description"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocumentVersion.publicDescription"/> </mapping> </element> <element id="ResearchStudy.enrollment"> <path value="ResearchStudy.enrollment"/> <short value="Inclusion & exclusion criteria"/> <definition value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"."/> <comment value="The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource."/> <alias value="patient"/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.enrollment"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=SBJ].role"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject"/> </mapping> </element> <element id="ResearchStudy.period"> <path value="ResearchStudy.period"/> <short value="When the study began and ended"/> <definition value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Start Date (start); Study Completion Date (end)"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.done[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/> </mapping> <mapping> <identity value="rim"/> <map value=".effectiveTime"/> </mapping> </element> <element id="ResearchStudy.sponsor"> <path value="ResearchStudy.sponsor"/> <short value="Organization that initiates and is legally responsible for the study"/> <definition value="An organization that initiates the investigation and is legally responsible for the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.sponsor"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Sponsor"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/> </mapping> </element> <element id="ResearchStudy.principalInvestigator"> <path value="ResearchStudy.principalInvestigator"/> <short value="Researcher who oversees multiple aspects of the study"/> <definition value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.principalInvestigator"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Principal Investigator"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyInvestigator"/> </mapping> </element> <element id="ResearchStudy.site"> <path value="ResearchStudy.site"/> <short value="Facility where study activities are conducted"/> <definition value="A facility in which study activities are conducted."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.site"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Facility"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.where[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="PlannedStudySite; StudySite"/> </mapping> </element> <element id="ResearchStudy.reasonStopped"> <path value="ResearchStudy.reasonStopped"/> <short value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close d-per-study-design"/> <definition value="A description and/or code explaining the premature termination of the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.reasonStopped"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for why the study ended prematurely."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyReasonStopped"/> </extension> <strength value="example"/> <description value="Codes for why the study ended prematurely."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Why Study Stopped"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.why[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyOverallStatus.studyStoppedReasonCode"/> </mapping> </element> <element id="ResearchStudy.note"> <path value="ResearchStudy.note"/> <short value="Comments made about the study"/> <definition value="Comments made about the study by the performer, subject or other participants."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.note"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Annotation"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping"/> </mapping> <mapping> <identity value="rim"/> <map value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/> </mapping> </element> <element id="ResearchStudy.arm"> <path value="ResearchStudy.arm"/> <short value="Defined path through the study for a subject"/> <definition value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.arm"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children unless an empty Parameters resource"/> <expression value="hasValue() or (children().count() > id.count()) or $this is Parameters"/> <xpath value="@value|f:*|h:div|self::f:Parameters"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arms"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm"/> </mapping> </element> <element id="ResearchStudy.arm.id"> <path value="ResearchStudy.arm.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUri value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchStudy.arm.extension"> <path value="ResearchStudy.arm.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchStudy.arm.modifierExtension"> <path value="ResearchStudy.arm.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.ht ml#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchStudy.arm.name"> <path value="ResearchStudy.arm.name"/> <short value="Label for study arm"/> <definition value="Unique, human-readable label for this arm of the study."/> <min value="1"/> <max value="1"/> <base> <path value="ResearchStudy.arm.name"/> <min value="1"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Label"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.name"/> </mapping> </element> <element id="ResearchStudy.arm.type"> <path value="ResearchStudy.arm.type"/> <short value="Categorization of study arm"/> <definition value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.arm.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Type"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.typeCode"/> </mapping> </element> <element id="ResearchStudy.arm.description"> <path value="ResearchStudy.arm.description"/> <short value="Short explanation of study path"/> <definition value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.arm.description"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Description"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.description"/> </mapping> </element> <element id="ResearchStudy.objective"> <path value="ResearchStudy.objective"/> <short value="A goal for the study"/> <definition value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/> <min value="0"/> <max value="*"/> <base> <path value="ResearchStudy.objective"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children unless an empty Parameters resource"/> <expression value="hasValue() or (children().count() > id.count()) or $this is Parameters"/> <xpath value="@value|f:*|h:div|self::f:Parameters"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudyObjective"/> </mapping> </element> <element id="ResearchStudy.objective.id"> <path value="ResearchStudy.objective.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <!-- Note: special primitive values have a FHIRPath system type. e.g. this is compiler magic (j) --> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUri value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchStudy.objective.extension"> <path value="ResearchStudy.objective.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="ResearchStudy.objective.modifierExtension"> <path value="ResearchStudy.objective.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.ht ml#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="ResearchStudy.objective.name"> <path value="ResearchStudy.objective.name"/> <short value="Label for the objective"/> <definition value="Unique, human-readable label for this objective of the study."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.objective.name"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (BRIDG has a description, but not a name)"/> </mapping> </element> <element id="ResearchStudy.objective.type"> <path value="ResearchStudy.objective.type"/> <short value="primary | secondary | exploratory"/> <definition value="The kind of study objective."/> <min value="0"/> <max value="1"/> <base> <path value="ResearchStudy.objective.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the kind of study objective."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyObjectiveType"/> </extension> <strength value="preferred"/> <description value="Codes for the kind of study objective."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyObjective.typeCode"/> </mapping> </element> </snapshot> <differential> <element id="ResearchStudy"> <path value="ResearchStudy"/> <short value="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="*"/> <mustSupport value="false"/> <isModifier value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="ObservationalStudyProtocolVersion; Study; StudyProtocolVersion"/> </mapping> <mapping> <identity value="v2"/> <map value="OBX"/> </mapping> <mapping> <identity value="rim"/> <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/> </mapping> <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> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Organization's Unique Protocol ID; Secondary IDs"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.identifier"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"/> </mapping> <mapping> <identity value="rim"/> <map value=".identifier"/> </mapping> </element> <element id="ResearchStudy.title"> <path value="ResearchStudy.title"/> <short value="Name for this study"/> <definition value="A short, descriptive user-friendly label for the study."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Brief Title"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/> </mapping> </element> <element id="ResearchStudy.protocol"> <path value="ResearchStudy.protocol"/> <short value="Steps followed in executing study"/> <definition value="The set of steps expected to be performed as part of the execution of the study."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PlanDefinition"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Interventions; Arm/Intervention Cross-Reference"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocumentVersionPublicTitle.name"/> </mapping> <mapping> <identity value="rim"/> <map value=".outboundRelationship[typeCode=DEFN].target"/> </mapping> </element> <element id="ResearchStudy.partOf"> <path value="ResearchStudy.partOf"/> <short value="Part of larger study"/> <definition value="A larger research study of which this particular study is a component or step."/> <requirements value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/> <alias value="container"/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="BRIDG5.1"/> <map value="CompanionStudyRelationship"/> </mapping> <mapping> <identity value="rim"/> <map value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/> </mapping> </element> <element id="ResearchStudy.status"> <path value="ResearchStudy.status"/> <short value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervent ion | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-acc rual-and-intervention | withdrawn"/> <definition value="The current state of the study."/> <min value="1"/> <max value="1"/> <type> <code value="code"/> </type> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes that convey the current status of the research study."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyStatus"/> </extension> <strength value="required"/> <description value="Codes that convey the current status of the research study."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-status|4.1.0"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.status"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyOverallStatus.code"/> </mapping> <mapping> <identity value="rim"/> <map value=".status"/> </mapping> </element> <element id="ResearchStudy.primaryPurposeType"> <path value="ResearchStudy.primaryPurposeType"/> <short value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/> <definition value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the main intent of the study."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyPrimaryPurposeType"/> </extension> <strength value="extensible"/> <description value="Codes for the main intent of the study."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.primaryPurposeTypeCode"/> </mapping> </element> <element id="ResearchStudy.phase"> <path value="ResearchStudy.phase"/> <short value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/> <definition value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyPhase"/> </extension> <strength value="example"/> <description value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Phase"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.phaseCode"/> </mapping> </element> <element id="ResearchStudy.category"> <path value="ResearchStudy.category"/> <short value="Classifications for the study"/> <definition value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyCategory"/> </extension> <strength value="example"/> <description value="Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyP rotocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol. controlTypeCode"/> </mapping> </element> <element id="ResearchStudy.focus"> <path value="ResearchStudy.focus"/> <short value="Drugs, devices, etc. under study"/> <definition value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for medications, devices and other interventions."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyFocus"/> </extension> <strength value="example"/> <description value="Codes for medications, devices and other interventions."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Focus of Study"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocol.interventionTypeCode"/> </mapping> </element> <element id="ResearchStudy.condition"> <path value="ResearchStudy.condition"/> <short value="Condition being studied"/> <definition value="The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Identification of the condition or diagnosis."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ConditionCode"/> </extension> <strength value="example"/> <description value="Identification of the condition or diagnosis."/> <valueSet value="http://hl7.org/fhir/ValueSet/condition-code"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Conditions"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyCondition.code"/> </mapping> </element> <element id="ResearchStudy.contact"> <path value="ResearchStudy.contact"/> <short value="Contact details for the study"/> <definition value="Contact details to assist a user in learning more about or engaging with the study."/> <min value="0"/> <max value="*"/> <type> <code value="ContactDetail"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVe rsion"/> </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> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Citations, Links, Available Study Data/Documents"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/> </mapping> </element> <element id="ResearchStudy.keyword"> <path value="ResearchStudy.keyword"/> <short value="Used to search for the study"/> <definition value="Key terms to aid in searching for or filtering the study."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Words associated with the study that may be useful in discovery."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyKeyword"/> </extension> <strength value="example"/> <description value="Words associated with the study that may be useful in discovery."/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Keywords"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/> </mapping> </element> <element id="ResearchStudy.location"> <path value="ResearchStudy.location"/> <short value="Geographic region(s) for study"/> <definition value="Indicates a country, state or other region where the study is taking place."/> <min value="0"/> <max value="*"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Countries and regions within which this artifact is targeted for use."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding"> <valueBoolean value="true"/> </extension> <strength value="extensible"/> <description value="Countries and regions within which this artifact is targeted for use."/> <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolVersion.participatingLocationCode"/> </mapping> </element> <element id="ResearchStudy.description"> <path value="ResearchStudy.description"/> <short value="What this is study doing"/> <definition value="A full description of how the study is being conducted."/> <min value="0"/> <max value="1"/> <type> <code value="markdown"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Detailed Description"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyProtocolDocumentVersion.publicDescription"/> </mapping> </element> <element id="ResearchStudy.enrollment"> <path value="ResearchStudy.enrollment"/> <short value="Inclusion & exclusion criteria"/> <definition value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. " 200 female Europeans between the ages of 20 and 45 with early onset diabetes"."/> <comment value="The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource."/> <alias value="patient"/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="InterventionalStudyProtocol.interventionGroupQuantity"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=SBJ].role"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.subject"/> </mapping> </element> <element id="ResearchStudy.period"> <path value="ResearchStudy.period"/> <short value="When the study began and ended"/> <definition value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/> <alias value="timing"/> <min value="0"/> <max value="1"/> <type> <code value="Period"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Study Start Date (start); Study Completion Date (end)"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.done[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/> </mapping> <mapping> <identity value="rim"/> <map value=".effectiveTime"/> </mapping> </element> <element id="ResearchStudy.sponsor"> <path value="ResearchStudy.sponsor"/> <short value="Organization that initiates and is legally responsible for the study"/> <definition value="An organization that initiates the investigation and is legally responsible for the study."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Sponsor"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/> </mapping> <mapping> <identity value="rim"/> <map value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/> </mapping> </element> <element id="ResearchStudy.principalInvestigator"> <path value="ResearchStudy.principalInvestigator"/> <short value="Researcher who oversees multiple aspects of the study"/> <definition value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/> <min value="0"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Principal Investigator"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.actor"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyInvestigator"/> </mapping> </element> <element id="ResearchStudy.site"> <path value="ResearchStudy.site"/> <short value="Facility where study activities are conducted"/> <definition value="A facility in which study activities are conducted."/> <min value="0"/> <max value="*"/> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Facility"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.where[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="PlannedStudySite; StudySite"/> </mapping> </element> <element id="ResearchStudy.reasonStopped"> <path value="ResearchStudy.reasonStopped"/> <short value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-close d-per-study-design"/> <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> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for why the study ended prematurely."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyReasonStopped"/> </extension> <strength value="example"/> <description value="Codes for why the study ended prematurely."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped"/> </binding> <mapping> <identity value="clinicaltrials-gov"/> <map value="Why Study Stopped"/> </mapping> <mapping> <identity value="w5"/> <map value="FiveWs.why[x]"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="StudyOverallStatus.studyStoppedReasonCode"/> </mapping> </element> <element id="ResearchStudy.note"> <path value="ResearchStudy.note"/> <short value="Comments made about the study"/> <definition value="Comments made about the study by the performer, subject or other participants."/> <min value="0"/> <max value="*"/> <type> <code value="Annotation"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping"/> </mapping> <mapping> <identity value="rim"/> <map value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/> </mapping> </element> <element id="ResearchStudy.arm"> <path value="ResearchStudy.arm"/> <short value="Defined path through the study for a subject"/> <definition value="Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arms"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm"/> </mapping> </element> <element id="ResearchStudy.arm.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> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Label"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.name"/> </mapping> </element> <element id="ResearchStudy.arm.type"> <path value="ResearchStudy.arm.type"/> <short value="Categorization of study arm"/> <definition value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Type"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.typeCode"/> </mapping> </element> <element id="ResearchStudy.arm.description"> <path value="ResearchStudy.arm.description"/> <short value="Short explanation of study path"/> <definition value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="clinicaltrials-gov"/> <map value="Arm Description"/> </mapping> <mapping> <identity value="BRIDG5.1"/> <map value="Arm.description"/> </mapping> </element> <element id="ResearchStudy.objective"> <path value="ResearchStudy.objective"/> <short value="A goal for the study"/> <definition value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/> <min value="0"/> <max value="*"/> <type> <code value="BackboneElement"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="StudyObjective"/> </mapping> </element> <element id="ResearchStudy.objective.name"> <path value="ResearchStudy.objective.name"/> <short value="Label for the objective"/> <definition value="Unique, human-readable label for this objective of the study."/> <min value="0"/> <max value="1"/> <type> <code value="string"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="BRIDG5.1"/> <map value="No BRIDG mapping (BRIDG has a description, but not a name)"/> </mapping> </element> <element id="ResearchStudy.objective.type"> <path value="ResearchStudy.objective.type"/> <short value="primary | secondary | exploratory"/> <definition value="The kind of study objective."/> <min value="0"/> <max value="1"/> <type> <code value="CodeableConcept"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/build/StructureDefinition/definition"> <valueString value="Codes for the kind of study objective."/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ResearchStudyObjectiveType"/> </extension> <strength value="preferred"/> <description value="Codes for the kind of study objective."/> <valueSet value="http://hl7.org/fhir/ValueSet/research-study-objective-type"/> </binding> <mapping> <identity value="BRIDG5.1"/> <map value="StudyObjective.typeCode"/> </mapping> </element> </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.
FHIR ®© HL7.org 2011+. FHIR R4B Ballot #1 hl7.fhir.core#4.1.0 generated on Thu, Mar 11, 2021 17:11+1100.
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