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Resource "ResearchSubject" Version "1" (StructureDefinition)

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XML or JSON representation. Try out the Profile as a questionnaire based web form . Edit this as XML or JSON. provenance for this resource

Name Flags Card. Type Description & Constraints doco
. . ResearchSubject TU DomainResource Physical entity which is the primary unit of interest in the study
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
. . . identifier Σ 0..* Identifier Business Identifier for research subject in a study
. . . status ?! Σ 1..1 code candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn
ResearchSubjectStatus ( Required)
. . . period Σ 0..1 Period Start and end of participation
. . . study Σ 1..1 Reference( ResearchStudy) Study subject is part of
. . . individual Σ 1..1 Reference( Patient) Who is part of study
. . . assignedArm 0..1 string What path should be followed
. . . actualArm 0..1 string What path was followed
. . . consent 0..1 Reference( Consent) Agreement to participate in study

doco Documentation for this format

{
  "resourceType" : "StructureDefinition",
  "id" : "ResearchSubject",
  "meta" : {
    "versionId" : "1",
    "lastUpdated" : "2018-12-14T02:04:34.301Z"
  },
  "text" : {
    "status" : "generated",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <table style=\"border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\" border=\"0\" cellpadding=\"0\" cellspacing=\"0\">\n <tr style=\"border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;\">\n <th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a title=\"The logical name of the element\" href=\"formats.html#table\">Name</a>\n </th>\n <th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a title=\"Information about the use of the element\" href=\"formats.html#table\">Flags</a>\n </th>\n <th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a title=\"Minimum and Maximum # of times the the element can appear in the instance\" href=\"formats.html#table\">Card.</a>\n </th>\n <th style=\"width: 100px\" class=\"hierarchy\">\n <a title=\"Reference to the type of the element\" href=\"formats.html#table\">Type</a>\n </th>\n <th style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a title=\"Additional information about the element\" href=\"formats.html#table\">Description &amp; Constraints</a>\n <span style=\"float: right\">\n <a title=\"Legend for this format\" href=\"formats.html#table\">\n <img alt=\"doco\" style=\"background-color: inherit\"/>\n </a>\n </span>\n </th>\n </tr>\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,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\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\"/> \n <span title=\"ResearchSubject : A physical entity which is the primary unit of operational and/or administrative interest in a study.\">ResearchSubject</span>\n <a name=\"ResearchSubject\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <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>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"domainresource.html\">DomainResource</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Physical entity which is the primary unit of interest in the study\n <br/>Elements defined in Ancestors: \n <a title=\"The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.\" href=\"resource.html#Resource\">id</a>, \n <a 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.\" href=\"resource.html#Resource\">meta</a>, \n <a 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.\" href=\"resource.html#Resource\">implicitRules</a>, \n <a title=\"The base language in which the resource is written.\" href=\"resource.html#Resource\">language</a>, \n <a 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 &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.\" href=\"domainresource.html#DomainResource\">text</a>, \n <a title=\"These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.\" href=\"domainresource.html#DomainResource\">contained</a>, \n <a title=\"May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.\" href=\"domainresource.html#DomainResource\">extension</a>, \n <a 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&apos;s descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.&#10;&#10;Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).\" href=\"domainresource.html#DomainResource\">modifierExtension</a>\n </td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,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\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\"/> \n <span title=\"ResearchSubject.identifier : Identifiers assigned to this research subject for a study.\">identifier</span>\n <a name=\"ResearchSubject.identifier\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">&#931;</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">0..*</td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"datatypes.html#Identifier\">Identifier</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Business Identifier for research subject in a study\n <br/>\n </td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\"/> \n <span title=\"ResearchSubject.status : The current state of the subject.\">status</span>\n <a name=\"ResearchSubject.status\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"conformance-rules.html#isModifier\" title=\"This element is a modifier element\">?!</a>\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">&#931;</a>\n </td>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"datatypes.html#code\">code</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn\n <br/>\n <a title=\"Indicates the progression of a study subject through a study.\" href=\"valueset-research-subject-status.html\">ResearchSubjectStatus</a> (\n <a title=\"To be conformant, the concept in this element SHALL be from the specified value set.\" href=\"terminologies.html#required\">Required</a>)\n </td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,R0lGODlhEAAQAPZ/APrkusOiYvvfqbiXWaV2G+jGhdq1b8GgYf3v1frw3vTUlsWkZNewbcSjY/DQkad4Hb6dXv3u0f3v1ObEgfPTlerJiP3w1v79+e7OkPrfrfnjuNOtZPrpydaxa+/YrvvdpP779ZxvFPvnwKKBQaFyF/369M2vdaqHRPz58/HNh/vowufFhfroxO3OkPrluv779tK0e6JzGProwvrow9m4eOnIifPTlPDPkP78+Naxaf3v0/zowfXRi+bFhLWUVv379/rnwPvszv3rye3LiPvnv+3MjPDasKiIS/789/3x2f747eXDg+7Mifvu0tu7f+/QkfDTnPXWmPrjsvrjtPbPgrqZW+/QlPz48K2EMv36866OUPvowat8Ivvgq/Pbrvzgq/PguvrgrqN0Gda2evfYm9+7d/rpw9q6e/LSku/Rl/XVl/LSlfrkt+zVqe7Wqv3x1/bNffbOf59wFdS6if3u0vrqyP3owPvepfXQivDQkO/PkKh9K7STVf779P///wD/ACH5BAEKAH8ALAAAAAAQABAAAAemgH+CgxeFF4OIhBdKGwFChYl/hYwbdkoBPnaQkosbG3d3VEpSUlonUoY1Gzo6QkI8SrGxWBOFG4uySgY5ZWR3PFy2hnaWZXC/PHcPwkpJk1ShoHcxhQEXSUmtFy6+0iSFVResrjoTPDzdcoU+F65CduVU6KAhhQa3F8Tx8nchBoYuqoTLZoAKFRIhqGwqJAULFx0GYpBQeChRIR4TJm6KJMhQRUSBAAA7\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Data Type\"/> \n <span title=\"ResearchSubject.period : The dates the subject began and ended their participation in the study.\">period</span>\n <a name=\"ResearchSubject.period\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">&#931;</a>\n </td>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"datatypes.html#Period\">Period</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Start and end of participation</td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\"/> \n <span title=\"ResearchSubject.study : Reference to the study the subject is participating in.\">study</span>\n <a name=\"ResearchSubject.study\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">&#931;</a>\n </td>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"references.html#Reference\">Reference</a>(\n <a href=\"researchstudy.html\">ResearchStudy</a>)\n </td>\n <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</td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\"/> \n <span title=\"ResearchSubject.individual : The record of the person or animal who is involved in the study.\">individual</span>\n <a name=\"ResearchSubject.individual\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a style=\"padding-left: 3px; padding-right: 3px; color: black; background-color: white\" href=\"elementdefinition-definitions.html#ElementDefinition.isSummary\" title=\"This element is included in summaries\">&#931;</a>\n </td>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"references.html#Reference\">Reference</a>(\n <a href=\"patient.html\">Patient</a>)\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Who is part of study</td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\"/> \n <span title=\"ResearchSubject.assignedArm : The name of the arm in the study the subject is expected to follow as part of this study.\">assignedArm</span>\n <a name=\"ResearchSubject.assignedArm\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"datatypes.html#string\">string</a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">What path should be followed</td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAL0lEQVR42u3XsQ0AQAgCQHdl/xn8jxvYWB3JlTR0VJLa+OltBwAAYP6EEQAAgCsPVYVAgIJrA/sAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzI3XJ6V3QAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+2RsQ0AIAzDav7/2VzQwoCY4iWbZSmo1QGoUgNMghvWaIejPQW/CrrNCylIwcOCDYfLNRcNer4SAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAACXBIWXMAAAsTAAALEwEAmpwYAAAARklEQVQ4y2P8//8/AyWAhYFCMAgMuHjx4n+KXaCv+I0szW8WpCG8kFO1lGFKW/SIjAUYgxz/MzAwMDC+nqhDUTQyjuYFBgCNmhP4OvTRgwAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Primitive Data Type\"/> \n <span title=\"ResearchSubject.actualArm : The name of the arm in the study the subject actually followed as part of this study.\">actualArm</span>\n <a name=\"ResearchSubject.actualArm\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"datatypes.html#string\">string</a>\n </td>\n <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</td>\n </tr>\n\n <tr style=\"border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white;\">\n <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/LjIAAAAI0lEQVR42u3QIQEAAAACIL/6/4MvTAQOkLYBAAB4kAAAANwMad9AqkRjgNAAAAAASUVORK5CYII=)\" class=\"hierarchy\">\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAEAAAAWCAYAAAABxvaqAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzIs1vtcMQAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAAE0lEQVQI12P4//8/AxMDAwNdCABMPwMo2ctnoQAAAABJRU5ErkJggg==\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAWCAYAAADJqhx8AAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3wYeFzME+lXFigAAAB1pVFh0Q29tbWVudAAAAAAAQ3JlYXRlZCB3aXRoIEdJTVBkLmUHAAAANklEQVQ4y+3OsRUAIAjEUOL+O8cJABttJM11/x1qZAGqRBEVcNIqdWj1efDqQbb3HwwwwEfABmQUHSPM9dtDAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: inherit\"/>\n <img src=\"data: image/png;base64,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAAAXNSR0IArs4c6QAAAARnQU1BAACxjwv8YQUAAAAJcEhZcwAADsMAAA7DAcdvqGQAAAAadEVYdFNvZnR3YXJlAFBhaW50Lk5FVCB2My41LjEwMPRyoQAAAFxJREFUOE/NjEEOACEIA/0o/38GGw+agoXYeNnDJDCUDnd/gkoFKhWozJiZI3gLwY6rAgxhsPKTPUzycTl8lAryMyMsVQG6TFi6cHULyz8KOjC7OIQKlQpU3uPjAwhX2CCcGsgOAAAAAElFTkSuQmCC\" class=\"hierarchy\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Reference to another Resource\"/> \n <span title=\"ResearchSubject.consent : A record of the patient&apos;s informed agreement to participate in the study.\">consent</span>\n <a name=\"ResearchSubject.consent\"> </a>\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"/>\n <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>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">\n <a href=\"references.html#Reference\">Reference</a>(\n <a href=\"consent.html\">Consent</a>)\n </td>\n <td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\">Agreement to participate in study</td>\n </tr>\n\n <tr>\n <td colspan=\"5\" class=\"hierarchy\">\n <br/>\n <a title=\"Legend for this format\" href=\"formats.html#table\">\n <img alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format\n </a>\n </td>\n </tr>\n </table>\n </div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
      "valueCode" : "trial-use"
    },
    {
      "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/structuredefinition-wg",
      "valueCode" : "brr"
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-category",
      "valueString" : "Specialized.Public Health &amp; Research"
    }
  ],
  "url" : "http://hl7.org/fhir/StructureDefinition/ResearchSubject",
  "version" : "4.0.0",
  "name" : "ResearchSubject",
  "status" : "draft",
  "date" : "2018-12-14T01:14:32+00:00",
  "publisher" : "Health Level Seven International (Biomedical Research and Regulation)",
  "contact" : [
    {
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://hl7.org/fhir"
        }
      ]
    },
    {
      "telecom" : [
        {
          "system" : "url",
          "value" : "http://www.hl7.org/Special/committees/rcrim/index.cfm"
        }
      ]
    }
  ],
  "description" : "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
  "fhirVersion" : "4.0.0",
  "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"
    },
    {
      "identity" : "w5",
      "uri" : "http://hl7.org/fhir/fivews",
      "name" : "FiveWs Pattern Mapping"
    }
  ],
  "kind" : "resource",
  "abstract" : false,
  "type" : "ResearchSubject",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/DomainResource",
  "derivation" : "specialization",
  "snapshot" : {
    "element" : [
      {
        "id" : "ResearchSubject",
        "path" : "ResearchSubject",
        "short" : "Physical entity which is the primary unit of interest in the study",
        "definition" : "A physical entity which is the primary unit of operational and/or administrative interest in a 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()",
            "xpath" : "not(parent::f:contained and f:contained)",
            "source" : "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()",
            "xpath" : "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
            "source" : "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().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()",
            "xpath" : "not(exists(for $contained in f:contained return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
            "source" : "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()",
            "xpath" : "exists(f:text/h:div)",
            "source" : "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()",
            "xpath" : "not(exists(f:contained/*/f:meta/f:security))",
            "source" : "DomainResource"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "rim",
            "map" : "Entity. Role, or Act"
          },
          {
            "identity" : "BRIDG5.1",
            "map" : "StudySubject"
          },
          {
            "identity" : "v2",
            "map" : "OBX"
          },
          {
            "identity" : "rim",
            "map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
          }
        ]
      },
      {
        "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" : "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.id",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "id"
          }
        ],
        "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"
          }
        ],
        "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 it's narrative along with other profiles, value sets, etc.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "Resource.implicitRules",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "uri"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation",
        "isSummary" : 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"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "binding" : {
          "extension" : [
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet",
              "valueCanonical" : "http://hl7.org/fhir/ValueSet/all-languages"
            },
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
              "valueString" : "Language"
            },
            {
              "url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding",
              "valueBoolean" : true
            }
          ],
          "strength" : "preferred",
          "description" : "A human language.",
          "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 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"
          }
        ],
        "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, and nor can they have their own independent transaction scope.",
        "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"
          }
        ],
        "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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
        "comment" : "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"
          }
        ],
        "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 manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\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"
          }
        ],
        "isModifier" : true,
        "isModifierReason" : "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
        "isSummary" : false,
        "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"
          }
        ],
        "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" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
        "definition" : "The current state of the subject.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ResearchSubject.status",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "code"
          }
        ],
        "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" : "ResearchSubjectStatus"
            }
          ],
          "strength" : "required",
          "description" : "Indicates the progression of a study subject through a study.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0"
        },
        "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"
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "w5",
            "map" : "FiveWs.planned"
          },
          {
            "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"
            ]
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "StudySubjectProtocolVersionRelationship"
          }
        ]
      },
      {
        "id" : "ResearchSubject.individual",
        "path" : "ResearchSubject.individual",
        "short" : "Who is part of study",
        "definition" : "The record of the person or animal who is involved in the study.",
        "min" : 1,
        "max" : "1",
        "base" : {
          "path" : "ResearchSubject.individual",
          "min" : 1,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Patient"
            ]
          }
        ],
        "isModifier" : false,
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "StudySubject"
          }
        ]
      },
      {
        "id" : "ResearchSubject.assignedArm",
        "path" : "ResearchSubject.assignedArm",
        "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.",
        "min" : 0,
        "max" : "1",
        "base" : {
          "path" : "ResearchSubject.assignedArm",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "isModifier" : false,
        "isSummary" : false,
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
          }
        ]
      },
      {
        "id" : "ResearchSubject.actualArm",
        "path" : "ResearchSubject.actualArm",
        "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.actualArm",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "string"
          }
        ],
        "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" : "1",
        "base" : {
          "path" : "ResearchSubject.consent",
          "min" : 0,
          "max" : "1"
        },
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Consent"
            ]
          }
        ],
        "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" : "Physical entity which is the primary unit of interest in the study",
        "definition" : "A physical entity which is the primary unit of operational and/or administrative interest in a study.",
        "comment" : "Need to make sure we encompass public health studies.",
        "alias" : [
          "Study Subject"
        ],
        "min" : 0,
        "max" : "*",
        "mapping" : [
          {
            "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"
          }
        ],
        "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" : "candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn",
        "definition" : "The current state of the subject.",
        "min" : 1,
        "max" : "1",
        "type" : [
          {
            "code" : "code"
          }
        ],
        "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" : "ResearchSubjectStatus"
            }
          ],
          "strength" : "required",
          "description" : "Indicates the progression of a study subject through a study.",
          "valueSet" : "http://hl7.org/fhir/ValueSet/research-subject-status|4.0.0"
        },
        "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"
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "w5",
            "map" : "FiveWs.planned"
          },
          {
            "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"
            ]
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "StudySubjectProtocolVersionRelationship"
          }
        ]
      },
      {
        "id" : "ResearchSubject.individual",
        "path" : "ResearchSubject.individual",
        "short" : "Who is part of study",
        "definition" : "The record of the person or animal who is involved in the study.",
        "min" : 1,
        "max" : "1",
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Patient"
            ]
          }
        ],
        "isSummary" : true,
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "StudySubject"
          }
        ]
      },
      {
        "id" : "ResearchSubject.assignedArm",
        "path" : "ResearchSubject.assignedArm",
        "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.",
        "min" : 0,
        "max" : "1",
        "type" : [
          {
            "code" : "string"
          }
        ],
        "mapping" : [
          {
            "identity" : "BRIDG5.1",
            "map" : "Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"
          }
        ]
      },
      {
        "id" : "ResearchSubject.actualArm",
        "path" : "ResearchSubject.actualArm",
        "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" : "string"
          }
        ],
        "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" : "1",
        "type" : [
          {
            "code" : "Reference",
            "targetProfile" : [
              "http://hl7.org/fhir/StructureDefinition/Consent"
            ]
          }
        ],
        "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."
          }
        ]
      }
    ]
  }
}