R6 Ballot (2nd Draft)
AdministrationPublish-box (todo)
| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Device, Patient |
Raw JSON (canonical form + also see JSON Format Specification)
StructureDefinition for researchsubject
{
"resourceType" : "StructureDefinition",
"id" : "ResearchSubject",
"meta" : {
"lastUpdated" : "2024-08-12T16:52:12.437+08:00"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\"><tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top\"><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"The logical name of the element\">Name</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Information about the use of the element\">Flags</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Minimum and Maximum # of times the element can appear in the instance\">Card.</a></th><th style=\"width: 100px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Reference to the type of the element\">Type</a></th><th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Additional information about the element\">Description & Constraints</a><span style=\"float: right\"><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/></a></span></th></tr><tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <span title=\"ResearchSubject : A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.\">ResearchSubject</span><a name=\"ResearchSubject\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; border: 1px grey solid; font-weight: bold; color: black; background-color: #fff5e6\" href=\"versions.html#std-process\" title=\"Standards Status = Trial Use\">TU</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"domainresource.html\">DomainResource</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Participant or object which is the recipient of investigative activities in a study<br/><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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.\">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 managable, 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 managable, 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.\n\nModifier 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>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.identifier : Identifiers assigned to this research subject for a study.\">identifier</span><a name=\"ResearchSubject.identifier\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">Σ</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#Identifier\">Identifier</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Business Identifier for research subject in a study<br/><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.status : The publication state of the resource (not of the subject).\">status</span><a name=\"ResearchSubject.status\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"conformance-rules.html#isModifier\" title=\"This element is a modifier element\">?!</a><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">Σ</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#code\">code</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">draft | active | retired | unknown<br/>Binding: <a href=\"valueset-publication-status.html\">PublicationStatus</a> (<a href=\"terminologies.html#required\" title=\"To be conformant, the concept in this element SHALL be from the specified value set.\">Required</a>)<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.period : The dates the subject began and ended their participation in the study.\">period</span><a name=\"ResearchSubject.period\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">Σ</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#Period\">Period</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start and end of participation<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <span title=\"ResearchSubject.study : Reference to the study the subject is participating in.\">study</span><a name=\"ResearchSubject.study\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">Σ</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"references.html#Reference\">Reference</a>(<a href=\"researchstudy.html\">ResearchStudy</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Study subject is part of<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subject : The record of the person, animal or other entity involved in the study.\">subject</span><a name=\"ResearchSubject.subject\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a style=\"padding-left: 3px; padding-right: 3px; color: black; null\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">Σ</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"references.html#Reference\">Reference</a>(<a href=\"patient.html\">Patient</a> | <a href=\"group.html\">Group</a> | <a href=\"specimen.html\">Specimen</a> | <a href=\"device.html\">Device</a> | <a href=\"medication.html\">Medication</a> | <a href=\"substance.html\">Substance</a> | <a href=\"biologicallyderivedproduct.html\">BiologicallyDerivedProduct</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Who or what is part of study<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw/npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///wD/ACH5BAEKAB8ALAAAAAAQABAAAAVl4CeOZGme5qCqqDg8jyVJaz1876DsmAQAgqDgltspMEhMJoMZ4iy6I1AooFCIv+wKybziALVAoAEjYLwDgGIpJhMslgxaLR4/3rMAWoBp32V5exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectState : A duration in the lifecycle of the ResearchSubject within a ResearchStudy.\">subjectState</span><a name=\"ResearchSubject.subjectState\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"types.html#BackBoneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A duration in the lifecycle of the ResearchSubject within a ResearchStudy<br/><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectState.code : Identifies the aspect of the subject's journey that the state refers to.\">code</span><a name=\"ResearchSubject.subjectState.code\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study<br/>Binding: <a href=\"valueset-research-subject-state.html\">Research Subject State</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>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectState.startDate : The date a research subject entered the given state.\">startDate</span><a name=\"ResearchSubject.subjectState.startDate\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#dateTime\">dateTime</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The date a research subject entered the given state<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectState.endDate : The date a research subject exited or left the given state.\">endDate</span><a name=\"ResearchSubject.subjectState.endDate\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#dateTime\">dateTime</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The date a research subject exited or left the given state<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL+O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectState.reason : The reason for the state change. If coded it should follow the formal subject state model.\">reason</span><a name=\"ResearchSubject.subjectState.reason\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">State change reason<br/>Binding: <a href=\"http://terminology.hl7.org/6.0.2/ValueSet-state-change-reason.html\">StateChangeReason</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>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,R0lGODlhEAAQAPQfAOvGUf7ztuvPMf/78/fkl/Pbg+u8Rvjqteu2Pf3zxPz36Pz0z+vTmPzurPvuw/npofbjquvNefHVduuyN+uuMu3Oafbgjfnqvf/3zv/3xevPi+vRjP/20/bmsP///wD/ACH5BAEKAB8ALAAAAAAQABAAAAVl4CeOZGme5qCqqDg8jyVJaz1876DsmAQAgqDgltspMEhMJoMZ4iy6I1AooFCIv+wKybziALVAoAEjYLwDgGIpJhMslgxaLR4/3rMAWoBp32V5exg8Shl1ckRUQVaMVkQ2kCstKCEAOw==\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectMilestone : A significant event in the progress of a ResearchSubject.\">subjectMilestone</span><a name=\"ResearchSubject.subjectMilestone\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"types.html#BackBoneElement\">BackboneElement</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">A significant event in the progress of a ResearchSubject<br/><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectMilestone.milestone : A specific event in the research subjects journey through a research study.\">milestone</span><a name=\"ResearchSubject.subjectMilestone.milestone\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">1..*</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">SignedUp | Screened | Randomized<br/>Binding: <a href=\"valueset-research-subject-milestone.html\">Research Subject Milestone</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/><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAMUlEQVR4Xu3LMQoAIBADwftr/v8GtdbqEAthAtMspJJUx9rYW8ftHwAA+NcRAAAAXplLq0BWj/rZigAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectMilestone.date : The date/time when this milestone event was completed.\">date</span><a name=\"ResearchSubject.subjectMilestone.date\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#dateTime\">dateTime</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">The date/time when this milestone event was completed<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzMPbYccAgAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAMElEQVQ4y+3OQREAIBDDwAv+PQcFFN5MIyCzqHMKUGVCpMFLK97heq+gggoq+EiwAVjvMhFGmlEUAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL+O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,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\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.subjectMilestone.reason : A rationale that provides additional clarification for the milestone that was captured or documented.\">reason</span><a name=\"ResearchSubject.subjectMilestone.reason\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#CodeableConcept\">CodeableConcept</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.assignedComparisonGroup : The name of the arm in the study the subject is expected to follow as part of this study.\">assignedComparisonGroup</span><a name=\"ResearchSubject.assignedComparisonGroup\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What path should be followed<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white\"><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAALUlEQVR4Xu3IoREAIAwEwfT6/ddA0GBAxO3NrLlKUj9263wAAAAvrgEAADClAVWFQIBRHMicAAAAAElFTkSuQmCC)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\" class=\"hierarchy\"/> <span title=\"ResearchSubject.actualComparisonGroup : The name of the arm in the study the subject actually followed as part of this study.\">actualComparisonGroup</span><a name=\"ResearchSubject.actualComparisonGroup\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..1</td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"datatypes.html#id\">id</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What path was followed<br/></td></tr>\r\n<tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7\"><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAyAAAAACCAYAAACg/LjIAAAAJUlEQVR4Xu3IIQEAAAgDsHd9/w4EQIOamFnaBgAA4MMKAACAKwNp30CqZFfFmwAAAABJRU5ErkJggg==)\" class=\"hierarchy\"><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL+O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Reference to another Resource\" class=\"hierarchy\"/> <span title=\"ResearchSubject.consent : A record of the patient's informed agreement to participate in the study.\">consent</span><a name=\"ResearchSubject.consent\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><a href=\"references.html#Reference\">Reference</a>(<a href=\"consent.html\">Consent</a>)</td><td style=\"vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Agreement to participate in study<br/><br/></td></tr>\r\n<tr><td colspan=\"5\" class=\"hierarchy\"><br/><a href=\"https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views\" title=\"Legend for this format\"><img src=\"data:image/png;base64,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\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
"valueString" : "Specialized.Public Health & Research"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
"valueCode" : "trial-use"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
"valueCode" : "brr"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
"valueInteger" : 0
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category",
"valueCode" : "patient"
}],
"url" : "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
"version" : "6.0.0-ballot2",
"name" : "ResearchSubject",
"status" : "draft",
"experimental" : true,
"date" : "2024-08-12T16:52:12+08:00",
"publisher" : "HL7 International / Biomedical Research and Regulation",
"contact" : [{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/fiwg"
}]
},
{
"telecom" : [{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/rcrim"
}]
}],
"description" : "A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.",
"jurisdiction" : [{
"coding" : [{
"system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
"code" : "001",
"display" : "World"
}]
}],
"fhirVersion" : "6.0.0-ballot2",
"mapping" : [{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
},
{
"identity" : "BRIDG5.1",
"uri" : "https://bridgmodel.nci.nih.gov",
"name" : "BRIDG 5.1 Mapping"
},
{
"identity" : "v2",
"uri" : "http://hl7.org/v2",
"name" : "HL7 V2 Mapping"
},
{
"identity" : "rim",
"uri" : "http://hl7.org/v3",
"name" : "RIM Mapping"
}],
"kind" : "resource",
"abstract" : false,
"type" : "ResearchSubject",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
"derivation" : "specialization",
"snapshot" : {
"element" : [{
"id" : "ResearchSubject",
"path" : "ResearchSubject",
"short" : "Participant or object which is the recipient of investigative activities in a study",
"definition" : "A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Study Subject"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject",
"min" : 0,
"max" : "*"
},
"constraint" : [{
"key" : "dom-2",
"severity" : "error",
"human" : "If the resource is contained in another resource, it SHALL NOT contain nested Resources",
"expression" : "contained.contained.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "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" : "contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"expression" : "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "If a resource is contained in another resource, it SHALL NOT have a security label",
"expression" : "contained.meta.security.empty()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation",
"valueMarkdown" : "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."
}],
"key" : "dom-6",
"severity" : "warning",
"human" : "A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]"
},
{
"identity" : "w5",
"map" : "clinical.diagnostics"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
},
{
"identity" : "v2",
"map" : "OBX"
}]
},
{
"id" : "ResearchSubject.id",
"path" : "ResearchSubject.id",
"short" : "Logical id of this artifact",
"definition" : "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchSubject.meta",
"path" : "ResearchSubject.meta",
"short" : "Metadata about the resource",
"definition" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.meta",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Meta"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchSubject.implicitRules",
"path" : "ResearchSubject.implicitRules",
"short" : "A set of rules under which this content was created",
"definition" : "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" : "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 its narrative along with other profiles, value sets, etc.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Resource.implicitRules",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "uri"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation",
"isSummary" : true
},
{
"id" : "ResearchSubject.language",
"path" : "ResearchSubject.language",
"short" : "Language of the resource content",
"definition" : "The base language in which the resource is written.",
"comment" : "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" : 0,
"max" : "1",
"base" : {
"path" : "Resource.language",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Language"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "required",
"description" : "IETF language tag for a human language",
"valueSet" : "http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot2",
"additional" : [{
"purpose" : "starter",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}]
}
},
{
"id" : "ResearchSubject.text",
"path" : "ResearchSubject.text",
"short" : "Text summary of the resource, for human interpretation",
"definition" : "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" : "Contained resources do not have a 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" : ["narrative",
"html",
"xhtml",
"display"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "DomainResource.text",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Narrative"
}],
"condition" : ["dom-6"],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "Act.text?"
}]
},
{
"id" : "ResearchSubject.contained",
"path" : "ResearchSubject.contained",
"short" : "Contained, inline Resources",
"definition" : "These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.",
"comment" : "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" : ["inline resources",
"anonymous resources",
"contained resources"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.contained",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Resource"
}],
"condition" : ["dom-2",
"dom-4",
"dom-3",
"dom-5"],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.extension",
"path" : "ResearchSubject.extension",
"short" : "Additional content defined by implementations",
"definition" : "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 managable, 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" : "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" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.modifierExtension",
"path" : "ResearchSubject.modifierExtension",
"short" : "Extensions that cannot be ignored",
"definition" : "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 managable, 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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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.html#modifierExtension).",
"alias" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "DomainResource.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.identifier",
"path" : "ResearchSubject.identifier",
"short" : "Business Identifier for research subject in a study",
"definition" : "Identifiers assigned to this research subject for a study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.identifier",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Identifier"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject > Subject.identifier"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchSubject.status",
"path" : "ResearchSubject.status",
"short" : "draft | active | retired | unknown",
"definition" : "The publication state of the resource (not of the subject).",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.status",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "code"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "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" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "required",
"description" : "Codes that convey the current publication status of the research study resource.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.period",
"path" : "ResearchSubject.period",
"short" : "Start and end of participation",
"definition" : "The dates the subject began and ended their participation in the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.period",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "Period"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "PerformedStudySubjectMilestone.studyReferenceDateRange"
}]
},
{
"id" : "ResearchSubject.study",
"path" : "ResearchSubject.study",
"short" : "Study subject is part of",
"definition" : "Reference to the study the subject is participating in.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.study",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubjectProtocolVersionRelationship"
}]
},
{
"id" : "ResearchSubject.subject",
"path" : "ResearchSubject.subject",
"short" : "Who or what is part of study",
"definition" : "The record of the person, animal or other entity involved in the study.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subject",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/Specimen",
"http://hl7.org/fhir/StructureDefinition/Device",
"http://hl7.org/fhir/StructureDefinition/Medication",
"http://hl7.org/fhir/StructureDefinition/Substance",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
}]
},
{
"id" : "ResearchSubject.subjectState",
"path" : "ResearchSubject.subjectState",
"short" : "A duration in the lifecycle of the ResearchSubject within a ResearchStudy",
"definition" : "A duration in the lifecycle of the ResearchSubject within a ResearchStudy.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.subjectState",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.id",
"path" : "ResearchSubject.subjectState.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"condition" : ["ele-1"],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.subjectState.extension",
"path" : "ResearchSubject.subjectState.extension",
"short" : "Additional content defined by implementations",
"definition" : "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 managable, 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" : "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" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.subjectState.modifierExtension",
"path" : "ResearchSubject.subjectState.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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 managable, 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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.subjectState.code",
"path" : "ResearchSubject.subjectState.code",
"short" : "candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study",
"definition" : "Identifies the aspect of the subject's journey that the state refers to.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectState.code",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectState"
}],
"strength" : "extensible",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.subjectState.startDate",
"path" : "ResearchSubject.subjectState.startDate",
"short" : "The date a research subject entered the given state",
"definition" : "The date a research subject entered the given state.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectState.startDate",
"min" : 1,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.endDate",
"path" : "ResearchSubject.subjectState.endDate",
"short" : "The date a research subject exited or left the given state",
"definition" : "The date a research subject exited or left the given state.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectState.endDate",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.reason",
"path" : "ResearchSubject.subjectState.reason",
"short" : "State change reason",
"definition" : "The reason for the state change. If coded it should follow the formal subject state model.",
"comment" : "Example, if the milestone is \"Randomized\" then the reason could be \"sponsor IVRS randomization code allocated\".",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectState.reason",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "StateChangeReason"
}],
"strength" : "example",
"description" : "Indicates why the state of the subject changed.",
"valueSet" : "http://terminology.hl7.org/ValueSet/state-change-reason"
}
},
{
"id" : "ResearchSubject.subjectMilestone",
"path" : "ResearchSubject.subjectMilestone",
"short" : "A significant event in the progress of a ResearchSubject",
"definition" : "A significant event in the progress of a ResearchSubject.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.subjectMilestone",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "BackboneElement"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectMilestone.id",
"path" : "ResearchSubject.subjectMilestone.id",
"representation" : ["xmlAttr"],
"short" : "Unique id for inter-element referencing",
"definition" : "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Element.id",
"min" : 0,
"max" : "1"
},
"type" : [{
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "string"
}],
"code" : "http://hl7.org/fhirpath/System.String"
}],
"condition" : ["ele-1"],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.subjectMilestone.extension",
"path" : "ResearchSubject.subjectMilestone.extension",
"short" : "Additional content defined by implementations",
"definition" : "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 managable, 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" : "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" : ["extensions",
"user content"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "rim",
"map" : "n/a"
}]
},
{
"id" : "ResearchSubject.subjectMilestone.modifierExtension",
"path" : "ResearchSubject.subjectMilestone.modifierExtension",
"short" : "Extensions that cannot be ignored even if unrecognized",
"definition" : "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 managable, 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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "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" : "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.html#modifierExtension).",
"alias" : ["extensions",
"user content",
"modifiers"],
"min" : 0,
"max" : "*",
"base" : {
"path" : "BackboneElement.modifierExtension",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Extension"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"isModifier" : true,
"isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
"isSummary" : true,
"mapping" : [{
"identity" : "rim",
"map" : "N/A"
}]
},
{
"id" : "ResearchSubject.subjectMilestone.milestone",
"path" : "ResearchSubject.subjectMilestone.milestone",
"short" : "SignedUp | Screened | Randomized",
"definition" : "A specific event in the research subjects journey through a research study.",
"min" : 1,
"max" : "*",
"base" : {
"path" : "ResearchSubject.subjectMilestone.milestone",
"min" : 1,
"max" : "*"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectMilestone"
}],
"strength" : "extensible",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-milestone"
}
},
{
"id" : "ResearchSubject.subjectMilestone.date",
"path" : "ResearchSubject.subjectMilestone.date",
"short" : "The date/time when this milestone event was completed",
"definition" : "The date/time when this milestone event was completed.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectMilestone.date",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "dateTime"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectMilestone.reason",
"path" : "ResearchSubject.subjectMilestone.reason",
"definition" : "A rationale that provides additional clarification for the milestone that was captured or documented.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.subjectMilestone.reason",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "CodeableConcept"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.assignedComparisonGroup",
"path" : "ResearchSubject.assignedComparisonGroup",
"short" : "What path should be followed",
"definition" : "The name of the arm in the study the subject is expected to follow as part of this study.",
"comment" : "Maybe this is really PlanDefinition.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.assignedComparisonGroup",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "id"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.actualComparisonGroup",
"path" : "ResearchSubject.actualComparisonGroup",
"short" : "What path was followed",
"definition" : "The name of the arm in the study the subject actually followed as part of this study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchSubject.actualComparisonGroup",
"min" : 0,
"max" : "1"
},
"type" : [{
"code" : "id"
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.consent",
"path" : "ResearchSubject.consent",
"short" : "Agreement to participate in study",
"definition" : "A record of the patient's informed agreement to participate in the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchSubject.consent",
"min" : 0,
"max" : "*"
},
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Consent"]
}],
"constraint" : [{
"key" : "ele-1",
"severity" : "error",
"human" : "All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
}]
}]
},
"differential" : {
"element" : [{
"id" : "ResearchSubject",
"path" : "ResearchSubject",
"short" : "Participant or object which is the recipient of investigative activities in a study",
"definition" : "A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.",
"comment" : "Need to make sure we encompass public health studies.",
"alias" : ["Study Subject"],
"min" : 0,
"max" : "*",
"mustSupport" : false,
"isModifier" : false,
"mapping" : [{
"identity" : "w5",
"map" : "clinical.diagnostics"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
}]
},
{
"id" : "ResearchSubject.identifier",
"path" : "ResearchSubject.identifier",
"short" : "Business Identifier for research subject in a study",
"definition" : "Identifiers assigned to this research subject for a study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Identifier"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject > Subject.identifier"
},
{
"identity" : "rim",
"map" : ".identifier"
}]
},
{
"id" : "ResearchSubject.status",
"path" : "ResearchSubject.status",
"short" : "draft | active | retired | unknown",
"definition" : "The publication state of the resource (not of the subject).",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "code"
}],
"mustSupport" : false,
"isModifier" : true,
"isModifierReason" : "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" : true,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "PublicationStatus"
},
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
"valueBoolean" : true
}],
"strength" : "required",
"description" : "Codes that convey the current publication status of the research study resource.",
"valueSet" : "http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot2"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.period",
"path" : "ResearchSubject.period",
"short" : "Start and end of participation",
"definition" : "The dates the subject began and ended their participation in the study.",
"alias" : ["timing"],
"min" : 0,
"max" : "1",
"type" : [{
"code" : "Period"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "PerformedStudySubjectMilestone.studyReferenceDateRange"
}]
},
{
"id" : "ResearchSubject.study",
"path" : "ResearchSubject.study",
"short" : "Study subject is part of",
"definition" : "Reference to the study the subject is participating in.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/ResearchStudy"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubjectProtocolVersionRelationship"
}]
},
{
"id" : "ResearchSubject.subject",
"path" : "ResearchSubject.subject",
"short" : "Who or what is part of study",
"definition" : "The record of the person, animal or other entity involved in the study.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Group",
"http://hl7.org/fhir/StructureDefinition/Specimen",
"http://hl7.org/fhir/StructureDefinition/Device",
"http://hl7.org/fhir/StructureDefinition/Medication",
"http://hl7.org/fhir/StructureDefinition/Substance",
"http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : true,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "StudySubject"
}]
},
{
"id" : "ResearchSubject.subjectState",
"path" : "ResearchSubject.subjectState",
"short" : "A duration in the lifecycle of the ResearchSubject within a ResearchStudy",
"definition" : "A duration in the lifecycle of the ResearchSubject within a ResearchStudy.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.code",
"path" : "ResearchSubject.subjectState.code",
"short" : "candidate | in-prescreening | in-screening | eligible | ineligible | on-study | on-study-intervention | in-follow-up | off-study",
"definition" : "Identifies the aspect of the subject's journey that the state refers to.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectState"
}],
"strength" : "extensible",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-state"
},
"mapping" : [{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudySubject.statusCode"
},
{
"identity" : "rim",
"map" : ".status"
}]
},
{
"id" : "ResearchSubject.subjectState.startDate",
"path" : "ResearchSubject.subjectState.startDate",
"short" : "The date a research subject entered the given state",
"definition" : "The date a research subject entered the given state.",
"min" : 1,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.endDate",
"path" : "ResearchSubject.subjectState.endDate",
"short" : "The date a research subject exited or left the given state",
"definition" : "The date a research subject exited or left the given state.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectState.reason",
"path" : "ResearchSubject.subjectState.reason",
"short" : "State change reason",
"definition" : "The reason for the state change. If coded it should follow the formal subject state model.",
"comment" : "Example, if the milestone is \"Randomized\" then the reason could be \"sponsor IVRS randomization code allocated\".",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "StateChangeReason"
}],
"strength" : "example",
"description" : "Indicates why the state of the subject changed.",
"valueSet" : "http://terminology.hl7.org/ValueSet/state-change-reason"
}
},
{
"id" : "ResearchSubject.subjectMilestone",
"path" : "ResearchSubject.subjectMilestone",
"short" : "A significant event in the progress of a ResearchSubject",
"definition" : "A significant event in the progress of a ResearchSubject.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "BackboneElement"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectMilestone.milestone",
"path" : "ResearchSubject.subjectMilestone.milestone",
"short" : "SignedUp | Screened | Randomized",
"definition" : "A specific event in the research subjects journey through a research study.",
"min" : 1,
"max" : "*",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchSubjectMilestone"
}],
"strength" : "extensible",
"description" : "Indicates the progression of a study subject through a study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-milestone"
}
},
{
"id" : "ResearchSubject.subjectMilestone.date",
"path" : "ResearchSubject.subjectMilestone.date",
"short" : "The date/time when this milestone event was completed",
"definition" : "The date/time when this milestone event was completed.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "dateTime"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.subjectMilestone.reason",
"path" : "ResearchSubject.subjectMilestone.reason",
"definition" : "A rationale that provides additional clarification for the milestone that was captured or documented.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "CodeableConcept"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false
},
{
"id" : "ResearchSubject.assignedComparisonGroup",
"path" : "ResearchSubject.assignedComparisonGroup",
"short" : "What path should be followed",
"definition" : "The name of the arm in the study the subject is expected to follow as part of this study.",
"comment" : "Maybe this is really PlanDefinition.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "id"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.actualComparisonGroup",
"path" : "ResearchSubject.actualComparisonGroup",
"short" : "What path was followed",
"definition" : "The name of the arm in the study the subject actually followed as part of this study.",
"min" : 0,
"max" : "1",
"type" : [{
"code" : "id"
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
}]
},
{
"id" : "ResearchSubject.consent",
"path" : "ResearchSubject.consent",
"short" : "Agreement to participate in study",
"definition" : "A record of the patient's informed agreement to participate in the study.",
"min" : 0,
"max" : "*",
"type" : [{
"code" : "Reference",
"targetProfile" : ["http://hl7.org/fhir/StructureDefinition/Consent"]
}],
"mustSupport" : false,
"isModifier" : false,
"isSummary" : false,
"mapping" : [{
"identity" : "BRIDG5.1",
"map" : "ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."
}]
}]
}
}
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 R6 hl7.fhir.core#6.0.0-ballot2 generated on Mon, Aug 12, 2024 16:59+0800.
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