診療情報提供書FHIR記述仕様 実装ガイド
1.1.6 - release
Japan
診療情報提供書FHIR記述仕様 実装ガイド
1.1.6 - release
Japan
診療情報提供書FHIR記述仕様 実装ガイド - Local Development build (v1.1.6) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Active as of 2023-03-31 |
JSON representation of the JP-ResearchStudy resource profile(リソースプロファイル).
{
"resourceType" : "StructureDefinition",
"id" : "JP-ResearchStudy",
"text" : {
"status" : "extensions",
"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 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(tbl_bck1.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_resource.png\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Resource\" class=\"hierarchy\"/> <a href=\"StructureDefinition-JP-ResearchStudy-definitions.html#ResearchStudy\">ResearchStudy</a><a name=\"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\"/><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=\"http://hl7.org/fhir/R4/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\"/></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(tbl_bck01.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: #F7F7F7; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-JP-ResearchStudy-definitions.html#ResearchStudy.meta\">meta</a><a name=\"ResearchStudy.meta\"> </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\"/><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\"/></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(tbl_bck000.png)\" class=\"hierarchy\"><img src=\"tbl_spacer.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_blank.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"tbl_vjoin_end.png\" alt=\".\" style=\"background-color: inherit\" class=\"hierarchy\"/><img src=\"icon_element.gif\" alt=\".\" style=\"background-color: white; background-color: inherit\" title=\"Element\" class=\"hierarchy\"/> <a href=\"StructureDefinition-JP-ResearchStudy-definitions.html#ResearchStudy.meta.lastUpdated\">lastUpdated</a><a name=\"ResearchStudy.meta.lastUpdated\"> </a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"padding-left: 3px; padding-right: 3px; color: white; background-color: red\" title=\"This element must be supported\">S</span></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">0</span><span style=\"opacity: 0.5\">..</span><span style=\"opacity: 0.5\">1</span></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=\"opacity: 0.5\" href=\"http://hl7.org/fhir/R4/datatypes.html#instant\">instant</a></td><td style=\"vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px\" class=\"hierarchy\"><span style=\"opacity: 0.5\">リソースのバージョンが最後に変更されたとき</span></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,iVBORw0KGgoAAAANSUhEUgAAABAAAAAQCAYAAAAf8/9hAAAABmJLR0QA/wD/AP+gvaeTAAAACXBIWXMAAAsTAAALEwEAmpwYAAAAB3RJTUUH3goXBCwdPqAP0wAAAldJREFUOMuNk0tIlFEYhp9z/vE2jHkhxXA0zJCMitrUQlq4lnSltEqCFhFG2MJFhIvIFpkEWaTQqjaWZRkp0g26URZkTpbaaOJkDqk10szoODP//7XIMUe0elcfnPd9zsfLOYplGrpRwZaqTtw3K7PtGem7Q6FoidbGgqHVy/HRb669R+56zx7eRV1L31JGxYbBtjKK93cxeqfyQHbehkZbUkK20goELEuIzEd+dHS+qz/Y8PTSif0FnGkbiwcAjHaU1+QWOptFiyCLp/LnKptpqIuXHx6rbR26kJcBX3yLgBfnd7CxwJmflpP2wUg0HIAoUUpZBmKzELGWcN8nAr6Gpu7tLU/CkwAaoKTWRSQyt89Q8w6J+oVQkKnBoblH7V0PPvUOvDYXfopE/SJmALsxnVm6LbkotrUtNowMeIrVrBcBpaMmdS0j9df7abpSuy7HWehwJdt1lhVwi/J58U5beXGAF6c3UXLycw1wdFklArBn87xdh0ZsZtArghBdAA3+OEDVubG4UEzP6x1FOWneHh2VDAHBAt80IbdXDcesNoCvs3E5AFyNSU5nbrDPZpcUEQQTFZiEVx+51fxMhhyJEAgvlriadIJZZksRuwBYMOPBbO3hePVVqgEJhFeUuFLhIPkRP6BQLIBrmMenujm/3g4zc398awIe90Zb5A1vREALqneMcYgP/xVQWlG+Ncu5vgwwlaUNx+3799rfe96u9K0JSDXcOzOTJg4B6IgmXfsygc7/Bvg9g9E58/cDVmGIBOP/zT8Bz1zqWqpbXIsd0O9hajXfL6u4BaOS6SeWAAAAAElFTkSuQmCC\" alt=\"doco\" style=\"background-color: inherit\"/> Documentation for this format</a></td></tr></table></div>"
},
"url" : "http://jpfhir.jp/fhir/core/StructureDefinition/JP_ResearchStudy",
"version" : "1.1.6",
"name" : "JP_ResearchStudy",
"status" : "active",
"date" : "2023-03-31",
"publisher" : "管理団体：（一社）日本HL7協会、（一社）日本医療情報学会.",
"contact" : [
{
"name" : "管理団体：（一社）日本HL7協会、（一社）日本医療情報学会.",
"telecom" : [
{
"system" : "url",
"value" : "http://jpfhir.jp"
},
{
"system" : "email",
"value" : "office@hlfhir.jp"
}
]
}
],
"description" : "Derived Profile from JP-Core",
"jurisdiction" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166-2",
"code" : "JP"
}
]
}
],
"copyright" : "（一社）日本HL7協会、（一社）日本医療情報学会. CC(Creative Commons) BY-ND 4.0",
"fhirVersion" : "4.0.1",
"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" : "clinicaltrials-gov",
"uri" : "http://clinicaltrials.gov",
"name" : "ClinicalTrials.gov Mapping"
},
{
"identity" : "w5",
"uri" : "http://hl7.org/fhir/fivews",
"name" : "FiveWs Pattern Mapping"
}
],
"kind" : "resource",
"abstract" : false,
"type" : "ResearchStudy",
"baseDefinition" : "http://hl7.org/fhir/StructureDefinition/ResearchStudy",
"derivation" : "constraint",
"snapshot" : {
"element" : [
{
"id" : "ResearchStudy",
"path" : "ResearchStudy",
"short" : "医療関連の患者に依存しない知識を高めるための調査 / Investigation to increase healthcare-related patient-independent knowledge",
"definition" : "研究者または組織が、医療関連の知識の分野を増やすことを目的とした一連のステップを計画し、実行するプロセス。これには、安全性、有効性、比較有効性、および薬、デバイス、治療、その他の介入および調査手法に関するその他の情報の研究が含まれます。研究の研究には、人間または動物の被験者に関する情報の収集が含まれます。 / A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge. This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques. A ResearchStudy involves the gathering of information about human or animal subjects.",
"comment" : "公衆衛生研究を網羅することを確認する必要があります。 / Need to make sure we encompass public health studies.",
"alias" : [
"Clinical Trial",
"Study"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy",
"min" : 0,
"max" : "*"
},
"constraint" : [
{
"key" : "dom-2",
"severity" : "error",
"human" : "リソースが別のリソースに含まれている場合、ネストされたリソースを含めてはなりません / 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" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-3",
"severity" : "error",
"human" : "リソースが別のリソースに含まれている場合、それはリソースの他の場所から参照されるか、含有リソースを参照するものとします / 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 $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-4",
"severity" : "error",
"human" : "リソースが別のリソースに含まれている場合、meta.versionidもmeta.lastupdatedも持ってはならない。 / 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" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
},
{
"key" : "dom-5",
"severity" : "error",
"human" : "別のリソースにリソースが含まれている場合、セキュリティラベルはありません / 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" : "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" : "リソースに叙述(Narative)がない場合、データを完全に理解するシステムのみがリソースを人間に安全に表示できます。リソースに人間の読み取り可能な表現を含めることは、はるかに堅牢なエコシステムと、仲介システムによるリソースのより安価な取り扱いになります。一部のエコシステムは、リソースの分布をリソースを完全に理解しているシステムのみに制限しており、その結果、実装者は叙述(Narative)が余計であると信じるかもしれません。しかし、経験によると、そのようなエコシステムは、多くの場合、時間の経過とともに新しい参加者に開かれています。 / 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" : "リソースには、堅牢な管理のための叙述(Narative)が必要です / A resource should have narrative for robust management",
"expression" : "text.`div`.exists()",
"xpath" : "exists(f:text/h:div)",
"source" : "http://hl7.org/fhir/StructureDefinition/DomainResource"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Entity. Role, or Act"
},
{
"identity" : "BRIDG5.1",
"map" : "ObservationalStudyProtocolVersion; Study;\nStudyProtocolVersion"
},
{
"identity" : "v2",
"map" : "OBX"
},
{
"identity" : "rim",
"map" : "Observation[classCode=CLNTRL, moodCode=EVN]"
}
]
},
{
"id" : "ResearchStudy.id",
"path" : "ResearchStudy.id",
"short" : "このアーティファクトの論理ID / Logical id of this artifact",
"definition" : "リソースのURLで使用されるリソースの論理ID。割り当てられたら、この値は変更されません。 / The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment" : "リソースにIDがないのは、IDが作成操作を使用してサーバーに送信されている場合です。 / 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" : [
{
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
"valueUrl" : "id"
}
],
"code" : "http://hl7.org/fhirpath/System.String"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta",
"path" : "ResearchStudy.meta",
"short" : "リソースに関するメタデータ / Metadata about the resource",
"definition" : "リソースに関するメタデータ。これは、インフラストラクチャによって維持されるコンテンツです。コンテンツの変更は、常にリソースのバージョンの変更に関連付けられているとは限りません。 / 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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta.id",
"path" : "ResearchStudy.meta.id",
"representation" : [
"xmlAttr"
],
"short" : "エレメント相互参照のためのユニークID",
"definition" : "リソース内の要素の固有ID（内部参照用）。これは、スペースを含まない任意の文字列値である可能性があります。",
"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"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.meta.extension",
"path" : "ResearchStudy.meta.extension",
"slicing" : {
"discriminator" : [
{
"type" : "value",
"path" : "url"
}
],
"description" : "拡張子は常にURLで切り片にされます。",
"rules" : "open"
},
"short" : "実装によって定義される追加コンテンツ",
"definition" : "要素の基本的な定義に含まれない追加情報を表すために使用されることがあります。拡張機能の使用を安全かつ管理しやすくするために、定義および使用に適用される厳格なガバナンスのセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たす必要のある要件のセットがあります。",
"comment" : "どのようなアプリケーション、プロジェクト、または標準が拡張機能を使用しているかに関わらず、拡張機能の使用には決して汚名が付くわけではありません - それらを使用または定義する機関または管轄区域に関係なく。拡張機能の使用こそが、FHIR仕様を誰にとっても簡単なコアレベルで維持することを可能にします。",
"alias" : [
"extensions",
"user content"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "Element.extension",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Extension"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "拡張機能または値[x]のいずれかが必要です。両方ではありません。",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.meta.versionId",
"path" : "ResearchStudy.meta.versionId",
"short" : "バージョン固有の識別子 (Baajon koyū no shikibetsu-shi)",
"definition" : "URLのバージョン部分に表示されるバージョン固有の識別子。この値は、リソースが作成、更新、または削除された場合に変更されます。",
"comment" : "サーバーがこの値を割り当て、クライアントが指定した値を無視する。ただし、サーバーが更新/削除時にバージョンの整合性を強制する場合を除く。",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Meta.versionId",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "id"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta.lastUpdated",
"path" : "ResearchStudy.meta.lastUpdated",
"short" : "リソースのバージョンが最後に変更されたとき",
"definition" : "リソースが最後に変更されたとき - 例えば、バージョンが変更されたとき。",
"comment" : "この値はリソースが初めて作成される場合を除いて常に設定されています。サーバー/リソースマネージャーがこの値を設定します。クライアントが提供する値は関係ありません。これはHTTP Last-Modifiedに相当し、[read](http://hl7.org/fhir/R4/http.html#read)のインタラクションで同じ値を持つべきです。",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Meta.lastUpdated",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "instant"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"mustSupport" : true,
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta.source",
"path" : "ResearchStudy.meta.source",
"short" : "「リソースがどこから来たかを特定する」",
"definition" : "リソースのソースシステムを識別するURI。これにより、リソース内の情報のソースをトラックまたは区別するために使用できる最小限の[プロビナンス]（provenance.html＃）情報が提供されます。ソースは、別のFHIRサーバー、ドキュメント、メッセージ、データベースなどを識別できます。",
"comment" : "プロバナンスのリソースにおいて、これはProvenance.entity.what[x]に対応します。ソースの正確な使用方法（および含意されるProvenance.entity.role）は実装者の判断に委ねられます。指定されたソースは1つだけです。追加のプロバナンスの詳細が必要な場合は、完全なプロバナンスリソースを使用するべきです。\n\nこの要素は、正規のURLでホストされていないリソースの現在のマスターソースがどこにあるかを示すために使用できます。",
"min" : 0,
"max" : "1",
"base" : {
"path" : "Meta.source",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "uri"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta.profile",
"path" : "ResearchStudy.meta.profile",
"short" : "このリソースが適合を主張するプロファイル",
"definition" : "このリソースが準拠すると主張する [StructureDefinition](structuredefinition.html#) リソースに関するプロファイルのリストです。URL は [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url) への参照です。",
"comment" : "これらの主張が時間の経過に伴って検証または更新される方法と、それらを決定するサーバーや他の基盤に任されます。プロファイルURLのリストは1セットです。",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Meta.profile",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "canonical",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/StructureDefinition"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true
},
{
"id" : "ResearchStudy.meta.security",
"path" : "ResearchStudy.meta.security",
"short" : "このリソースに適用されたセキュリティラベル",
"definition" : "このリソースにはセキュリティラベルが適用されています。これらのタグにより、特定のリソースが全体的なセキュリティポリシーやインフラストラクチャに関連付けられます。",
"comment" : "セキュリティラベルは変更せずにリソースのバージョンを更新可能です。セキュリティラベルのリストはセットであり、一意性はシステム/コードに基づき、バージョンと表示は無視されます。",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Meta.security",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Coding"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "SecurityLabels"
}
],
"strength" : "extensible",
"description" : "医療プライバシーおよびセキュリティ分類システムからのセキュリティラベル。",
"valueSet" : "http://hl7.org/fhir/ValueSet/security-labels"
}
},
{
"id" : "ResearchStudy.meta.tag",
"path" : "ResearchStudy.meta.tag",
"short" : "このリソースに適用されたタグ",
"definition" : "このリソースに適用されるタグです。タグは、リソースをプロセスやワークフローに識別し、関連付けるために使用することが意図されており、アプリケーションはリソースの意味を解釈する際にタグを考慮する必要はありません。",
"comment" : "リソースの表示バージョンを変更することなく、タグを更新できます。タグのリストは集合です。ユニーク性はシステム/コードに基づき、バージョンと表示は無視されます。",
"min" : 0,
"max" : "*",
"base" : {
"path" : "Meta.tag",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Coding"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素は、@valueまたはchildrenを持っている必要があります。",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Tags"
}
],
"strength" : "example",
"description" : "様々なタグを表すコードで、一般的にはワークフローに関連しています。例：「ジョーンズ博士によるレビューが必要です」。",
"valueSet" : "http://hl7.org/fhir/ValueSet/common-tags"
}
},
{
"id" : "ResearchStudy.implicitRules",
"path" : "ResearchStudy.implicitRules",
"short" : "このコンテンツが作成されたルールのセット / A set of rules under which this content was created",
"definition" : "リソースが構築されたときに従った一連のルールへの参照。コンテンツの処理時に理解する必要があります。多くの場合、これは他のプロファイルなどとともに特別なルールを定義する実装ガイドへの参照です。 / 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" : "このルールセットを主張することは、コンテンツが限られた取引パートナーのセットによってのみ理解されることを制限します。これにより、本質的に長期的にデータの有用性が制限されます。ただし、既存の健康エコシステムは非常に破壊されており、一般的に計算可能な意味でデータを定義、収集、交換する準備ができていません。可能な限り、実装者や仕様ライターはこの要素の使用を避ける必要があります。多くの場合、使用する場合、URLは、これらの特別なルールを他のプロファイル、バリューセットなどとともに叙述(Narative)の一部として定義する実装ガイドへの参照です。 / 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"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "暗黙のルールは、意味または解釈を変更するリソースに関する追加の知識を提供する可能性があるため、この要素は修飾子としてラベル付けされています。 / 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" : "ResearchStudy.language",
"path" : "ResearchStudy.language",
"short" : "リソースコンテンツの言語 / Language of the resource content",
"definition" : "リソースが書かれている基本言語。 / The base language in which the resource is written.",
"comment" : "言語は、インデックス作成とアクセシビリティをサポートするために提供されます（通常、テキストから音声までのサービスなどのサービスが言語タグを使用します）。叙述(Narative)のHTML言語タグは、叙述(Narative)に適用されます。リソース上の言語タグを使用して、リソース内のデータから生成された他のプレゼンテーションの言語を指定できます。すべてのコンテンツが基本言語である必要はありません。リソース。言語は、叙述(Narative)に自動的に適用されると想定されるべきではありません。言語が指定されている場合、HTMLのDIV要素にも指定されている場合（XML：LangとHTML Lang属性の関係については、HTML5のルールを参照してください）。 / 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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"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"
}
],
"strength" : "preferred",
"description" : "人間の言語。 / A human language.",
"valueSet" : "http://hl7.org/fhir/ValueSet/languages"
}
},
{
"id" : "ResearchStudy.text",
"path" : "ResearchStudy.text",
"short" : "人間の解釈のためのリソースのテキスト概要 / Text summary of the resource, for human interpretation",
"definition" : "リソースの概要を含み、人間へのリソースの内容を表すために使用できる人間の読み取り可能な叙述(Narative)。叙述(Narative)はすべての構造化されたデータをエンコードする必要はありませんが、人間が叙述(Narative)を読むだけで「臨床的に安全」にするために十分な詳細を含める必要があります。リソースの定義は、臨床的安全を確保するために、叙述(Narative)で表現するコンテンツを定義する場合があります。 / 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" : "含まれるリソースには叙述(Narative)がありません。含まれていないリソースには叙述(Narative)が必要です。場合によっては、リソースには、追加の個別のデータがほとんどまたはまったくないテキストのみがあります（すべてのMinoccur = 1要素が満たされている限り）。これは、情報がtext blob (バイナリー ラージ オブジェクト)としてキャプチャされるレガシーシステムからのデータ、またはテキストが生またはナレーションされ、エンコードされた情報が後で追加される場合に必要になる場合があります。 / 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"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "Act.text?"
}
]
},
{
"id" : "ResearchStudy.contained",
"path" : "ResearchStudy.contained",
"short" : "インラインリソースが含まれています / Contained, inline Resources",
"definition" : "これらのリソースには、それらを含むリソースを除いて独立した存在はありません - 独立して特定することはできず、独自の独立したトランザクションスコープを持つこともできません。 / 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" : "識別が失われると、コンテンツを適切に識別できる場合は、これを行うべきではありません。含まれるリソースには、メタ要素にプロファイルとタグがある場合がありますが、セキュリティラベルはありません。 / 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" : "ResearchStudy.extension",
"path" : "ResearchStudy.extension",
"short" : "実装で定義された追加のコンテンツ / Additional content defined by implementations",
"definition" : "リソースの基本的な定義の一部ではない追加情報を表すために使用できます。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たされる一連の要件があります。 / 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" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "N/A"
}
]
},
{
"id" : "ResearchStudy.modifierExtension",
"path" : "ResearchStudy.modifierExtension",
"short" : "無視できない拡張機能 / Extensions that cannot be ignored",
"definition" : "リソースの基本的な定義の一部ではなく、それを含む要素の理解および/または含有要素の子孫の理解を変更するために使用される場合があります。通常、修飾子要素は否定または資格を提供します。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義することが許可されていますが、拡張機能の定義の一部として満たされる一連の要件があります。アプリケーションの処理リソースは、修飾子拡張機能をチェックする必要があります。\n\nモディファイア拡張は、リソースまたはdomainResource上の要素の意味を変更してはなりません（修飾軸自体の意味を変更することはできません）。 / 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" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "修飾子拡張機能により、安全に無視できる大部分の拡張機能と明確に区別できるように、安全に無視できない拡張機能が可能になります。これにより、実装者が拡張の存在を禁止する必要性を排除することにより、相互運用性が促進されます。詳細については、[修飾子拡張の定義]（拡張性.html＃modifierextension）を参照してください。 / 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](http://hl7.org/fhir/R4/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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "モディファイア拡張は、それらを含むリソースの意味または解釈を変更することが期待されています / 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" : "ResearchStudy.identifier",
"path" : "ResearchStudy.identifier",
"short" : "研究のためのビジネス識別子 / Business Identifier for study",
"definition" : "スポンサーまたは他のシステムによるこの調査研究に割り当てられた識別子。 / Identifiers assigned to this research study by the sponsor or other systems.",
"requirements" : "さまざまな参加システムで知られており、サーバー全体で一貫性を保っている方法で、調査研究を特定できます。 / Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.identifier",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Identifier"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Organization's Unique Protocol ID; Secondary IDs"
},
{
"identity" : "w5",
"map" : "FiveWs.identifier"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)"
},
{
"identity" : "rim",
"map" : ".identifier"
}
]
},
{
"id" : "ResearchStudy.title",
"path" : "ResearchStudy.title",
"short" : "この調査の名前 / Name for this study",
"definition" : "研究のための短い、説明的なユーザーフレンドリーなラベル。 / A short, descriptive user-friendly label for the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.title",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Brief Title"
},
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"
}
]
},
{
"id" : "ResearchStudy.protocol",
"path" : "ResearchStudy.protocol",
"short" : "研究の実行に従ったプロシジャー（処置等） / Steps followed in executing study",
"definition" : "一連のステップは、研究の実行の一部として実行されると予想されます。 / The set of steps expected to be performed as part of the execution of the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.protocol",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/PlanDefinition"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Interventions; Arm/Intervention Cross-Reference"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersionPublicTitle.name"
},
{
"identity" : "rim",
"map" : ".outboundRelationship[typeCode=DEFN].target"
}
]
},
{
"id" : "ResearchStudy.partOf",
"path" : "ResearchStudy.partOf",
"short" : "大規模な研究の一部 / Part of larger study",
"definition" : "この特定の研究がコンポーネントまたはステップである大規模な調査研究。 / A larger research study of which this particular study is a component or step.",
"requirements" : "独自のPI、ステータス、登録などで、それぞれのコンポーネント（例えば、調査サイトによる）に研究を破壊することができます。 / Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.",
"alias" : [
"container"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.partOf",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/ResearchStudy"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "CompanionStudyRelationship"
},
{
"identity" : "rim",
"map" : ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"
}
]
},
{
"id" : "ResearchStudy.status",
"path" : "ResearchStudy.status",
"short" : "アクティブ|管理上完成|承認|閉じたcrual |閉じたcrualとintervention |完了|不承認|in-review |一時的に閉鎖されてから刻まれています|一時的に閉鎖されてから断続的に介入している|引きこもった / active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn",
"definition" : "研究の現状。 / The current state of the study.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.status",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "code"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : true,
"isModifierReason" : "この要素は、リソースを有効として扱うべきではないことを意味するステータスに入力されたステータスを含むステータス要素であるため、修飾子としてラベル付けされています。 / 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" : "ResearchStudyStatus"
}
],
"strength" : "required",
"description" : "調査研究の現在の状況を伝えるコード。 / Codes that convey the current status of the research study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-status|4.0.1"
},
"mapping" : [
{
"identity" : "w5",
"map" : "FiveWs.status"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.code"
},
{
"identity" : "rim",
"map" : ".status"
}
]
},
{
"id" : "ResearchStudy.primaryPurposeType",
"path" : "ResearchStudy.primaryPurposeType",
"short" : "治療|予防|診断|サポートケア|スクリーニング|Health-Services-Research |基本的な科学|デバイスの可能性 / treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility",
"definition" : "研究の活動の意図に基づく研究の種類。研究の意図の分類。 / The type of study based upon the intent of the study's activities. A classification of the intent of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.primaryPurposeType",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPrimaryPurposeType"
}
],
"strength" : "extensible",
"description" : "研究の主な意図をコードします。 / Codes for the main intent of the study.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-prim-purp-type"
},
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.primaryPurposeTypeCode"
}
]
},
{
"id" : "ResearchStudy.phase",
"path" : "ResearchStudy.phase",
"short" : "n-a |初期段階-1 |フェーズ-1 |フェーズ-1フェーズ-2 |フェーズ-2 |フェーズ-2相-3 |フェーズ3 |フェーズ4 / n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4",
"definition" : "臨床試験におけるヒトでの最初の実験的使用から市場後の評価への治療の進行の段階。 / The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.phase",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyPhase"
}
],
"strength" : "example",
"description" : "臨床試験におけるヒトの初期実験的使用から市場後の評価への治療の進行の段階のコード。 / Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Phase"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.phaseCode"
}
]
},
{
"id" : "ResearchStudy.category",
"path" : "ResearchStudy.category",
"short" : "研究の分類 / Classifications for the study",
"definition" : "調査対観測、盲検化の種類、ランダム化の種類、安全性と有効性などのタイプの研究を分類するコード。 / Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.category",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyCategory"
}
],
"strength" : "example",
"description" : "調査研究の種類を説明するコード。例えば。研究段階、介入/観察、盲検化タイプなど。 / Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc."
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"
}
]
},
{
"id" : "ResearchStudy.focus",
"path" : "ResearchStudy.focus",
"short" : "研究中の薬物、デバイスなど / Drugs, devices, etc. under study",
"definition" : "薬物、食物、療法（IES）、デバイスまたはその他の懸念または介入が、研究がより多くの情報を得ようとしている介入。 / The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.focus",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyFocus"
}
],
"strength" : "example",
"description" : "薬、デバイス、その他の介入のコード。 / Codes for medications, devices and other interventions."
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Focus of Study"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionTypeCode"
}
]
},
{
"id" : "ResearchStudy.condition",
"path" : "ResearchStudy.condition",
"short" : "研究されている状態 / Condition being studied",
"definition" : "研究の焦点である状態。たとえば、ループスの危険因子を調べるための研究では、「健全なボランティア」を含む基準として持っている可能性がありますが、ターゲット条件コードはループススノムコードです。 / The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion \"healthy volunteer\", but the target condition code would be a Lupus SNOMED code.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.condition",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ConditionCode"
}
],
"strength" : "example",
"description" : "状態または診断の識別。 / Identification of the condition or diagnosis.",
"valueSet" : "http://hl7.org/fhir/ValueSet/condition-code"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Conditions"
},
{
"identity" : "w5",
"map" : "FiveWs.what[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyCondition.code"
}
]
},
{
"id" : "ResearchStudy.contact",
"path" : "ResearchStudy.contact",
"short" : "調査の連絡先の詳細 / Contact details for the study",
"definition" : "ユーザーが調査の詳細または研究を学ぶのを支援するための連絡先の詳細。 / Contact details to assist a user in learning more about or engaging with the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.contact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "ContactDetail"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators"
},
{
"identity" : "BRIDG5.1",
"map" : "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion"
}
]
},
{
"id" : "ResearchStudy.relatedArtifact",
"path" : "ResearchStudy.relatedArtifact",
"short" : "参照と依存関係 / References and dependencies",
"definition" : "引用、参照、その他の関連文書。 / Citations, references and other related documents.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.relatedArtifact",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "RelatedArtifact"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Citations, Links, Available Study Data/Documents"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocument, StudyProtocolDocumentVersion"
}
]
},
{
"id" : "ResearchStudy.keyword",
"path" : "ResearchStudy.keyword",
"short" : "研究の検索に使用されます / Used to search for the study",
"definition" : "研究の検索またはフィルタリングを支援する重要な用語。 / Key terms to aid in searching for or filtering the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.keyword",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyKeyword"
}
],
"strength" : "example",
"description" : "発見に役立つかもしれない研究に関連する言葉。 / Words associated with the study that may be useful in discovery."
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Keywords"
},
{
"identity" : "BRIDG5.1",
"map" : "DocumentVersion.keywordCode; DocumentVersion.keywordText"
}
]
},
{
"id" : "ResearchStudy.location",
"path" : "ResearchStudy.location",
"short" : "研究のための地理的領域 / Geographic region(s) for study",
"definition" : "研究が行われている国、州、またはその他の地域を示します。 / Indicates a country, state or other region where the study is taking place.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.location",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "Jurisdiction"
}
],
"strength" : "extensible",
"description" : "このアーティファクトが使用することを目的としている国と地域。 / Countries and regions within which this artifact is targeted for use.",
"valueSet" : "http://hl7.org/fhir/ValueSet/jurisdiction"
},
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolVersion.participatingLocationCode"
}
]
},
{
"id" : "ResearchStudy.description",
"path" : "ResearchStudy.description",
"short" : "これは研究とは何ですか / What this is study doing",
"definition" : "研究がどのように実施されているかについての完全な説明。 / A full description of how the study is being conducted.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "markdown"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Detailed Description"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyProtocolDocumentVersion.publicDescription"
}
]
},
{
"id" : "ResearchStudy.enrollment",
"path" : "ResearchStudy.enrollment",
"short" : "包含および除外基準 / Inclusion & exclusion criteria",
"definition" : "研究に参加している被験者の基準と数量を定義するグループへの参照。例えば。「20歳から45歳までの200人の女性ヨーロッパ人が早期発症糖尿病で」。 / Reference to a Group that defines the criteria for and quantity of subjects participating in the study. E.g. \" 200 female Europeans between the ages of 20 and 45 with early onset diabetes\".",
"comment" : "参照されているグループは、一般に特定の被験者を列挙すべきではありません。被験者は、ResearchSubject Resourceを使用した研究にリンクされます。 / The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.",
"alias" : [
"patient"
],
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.enrollment",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Group"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Enrollment; Number of Groups/Cohorts (= number of \"enrollment\" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"
},
{
"identity" : "w5",
"map" : "FiveWs.subject[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "InterventionalStudyProtocol.interventionGroupQuantity"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=SBJ].role"
},
{
"identity" : "w5",
"map" : "FiveWs.subject"
}
]
},
{
"id" : "ResearchStudy.period",
"path" : "ResearchStudy.period",
"short" : "研究が始まって終了したとき / When the study began and ended",
"definition" : "研究の開始日と予想される（またはステータスに応じて）終了日を識別します。 / Identifies the start date and the expected (or actual, depending on status) end date for the study.",
"alias" : [
"timing"
],
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.period",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Period"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Study Start Date (start); Study Completion Date (end)"
},
{
"identity" : "w5",
"map" : "FiveWs.done[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"
},
{
"identity" : "rim",
"map" : ".effectiveTime"
}
]
},
{
"id" : "ResearchStudy.sponsor",
"path" : "ResearchStudy.sponsor",
"short" : "研究を開始し、法的責任を負う組織 / Organization that initiates and is legally responsible for the study",
"definition" : "調査を開始し、研究に法的責任を負う組織。 / An organization that initiates the investigation and is legally responsible for the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.sponsor",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Organization"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Sponsor"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"
},
{
"identity" : "rim",
"map" : ".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"
}
]
},
{
"id" : "ResearchStudy.principalInvestigator",
"path" : "ResearchStudy.principalInvestigator",
"short" : "研究の複数の側面を監督する研究者 / Researcher who oversees multiple aspects of the study",
"definition" : "概念開発、プロトコルライティング、IRB承認のプロトコル提出、参加者の募集、インフォームドコンセント、データ収集、分析、解釈、プレゼンテーションなど、研究の複数の側面を監督する研究の研究者。 / A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.principalInvestigator",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Practitioner"🔗 ,
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Principal Investigator"
},
{
"identity" : "w5",
"map" : "FiveWs.actor"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyInvestigator"
}
]
},
{
"id" : "ResearchStudy.site",
"path" : "ResearchStudy.site",
"short" : "研究活動が実施される施設 / Facility where study activities are conducted",
"definition" : "研究活動が実施される施設。 / A facility in which study activities are conducted.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.site",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Reference",
"targetProfile" : [
🔗 "http://hl7.org/fhir/StructureDefinition/Location"
]
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Facility"
},
{
"identity" : "w5",
"map" : "FiveWs.where[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "PlannedStudySite; StudySite"
}
]
},
{
"id" : "ResearchStudy.reasonStopped",
"path" : "ResearchStudy.reasonStopped",
"short" : "ACRUAL-GOAL-MET |クローズドデューから毒性|閉じた距離からlack-of-study-progress |一時的に閉じられたスタディデザイン / accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design",
"definition" : "研究の早期終了を説明する説明および/またはコード。 / A description and/or code explaining the premature termination of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.reasonStopped",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : true,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyReasonStopped"
}
],
"strength" : "example",
"description" : "研究が時期尚早に終了した理由をコードします。 / Codes for why the study ended prematurely.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-reason-stopped"
},
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Why Study Stopped"
},
{
"identity" : "w5",
"map" : "FiveWs.why[x]"
},
{
"identity" : "BRIDG5.1",
"map" : "StudyOverallStatus.studyStoppedReasonCode"
}
]
},
{
"id" : "ResearchStudy.note",
"path" : "ResearchStudy.note",
"short" : "研究についてのコメント / Comments made about the study",
"definition" : "パフォーマー、被験者、または他の参加者による研究についてのコメント。 / Comments made about the study by the performer, subject or other participants.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.note",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "Annotation"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping"
},
{
"identity" : "rim",
"map" : ".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"
}
]
},
{
"id" : "ResearchStudy.arm",
"path" : "ResearchStudy.arm",
"short" : "被験者の研究を通して定義されたパス / Defined path through the study for a subject",
"definition" : "研究の参加者の1人に予想される一連のイベントについて説明します。例えば。薬物Aへの曝露、ウォッシュアウト、薬物Bへの暴露、ウォッシュアウト、フォローアップ。 / Describes an expected sequence of events for one of the participants of a study. E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.arm",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Arms"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm"
}
]
},
{
"id" : "ResearchStudy.arm.id",
"path" : "ResearchStudy.arm.id",
"representation" : [
"xmlAttr"
],
"short" : "要素間参照のための一意のID / Unique id for inter-element referencing",
"definition" : "リソース内の要素の一意のID（内部参照用）。これは、スペースを含まない文字列値である場合があります。 / 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"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.arm.extension",
"path" : "ResearchStudy.arm.extension",
"short" : "実装で定義された追加のコンテンツ / Additional content defined by implementations",
"definition" : "要素の基本的な定義の一部ではない追加情報を表すために使用できます。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たされる一連の要件があります。 / May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.arm.modifierExtension",
"path" : "ResearchStudy.arm.modifierExtension",
"short" : "認識されていなくても無視できない拡張機能 / Extensions that cannot be ignored even if unrecognized",
"definition" : "要素の基本的な定義の一部ではなく、それが含まれている要素の理解、および/または含まれる要素の子孫の理解を変更するために使用される場合があります。通常、修飾子要素は否定または資格を提供します。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たされる一連の要件があります。アプリケーションの処理リソースは、修飾子拡張機能をチェックする必要があります。\n\nモディファイア拡張は、リソースまたはdomainResource上の要素の意味を変更してはなりません（修飾軸自体の意味を変更することはできません）。 / May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "修飾子拡張機能により、安全に無視できる大部分の拡張機能と明確に区別できるように、安全に無視できない拡張機能が可能になります。これにより、実装者が拡張の存在を禁止する必要性を排除することにより、相互運用性が促進されます。詳細については、[修飾子拡張の定義]（拡張性.html＃modifierextension）を参照してください。 / 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](http://hl7.org/fhir/R4/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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "修飾子拡張は、それらを含む要素の意味または解釈を変更することが期待されています / 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" : "ResearchStudy.arm.name",
"path" : "ResearchStudy.arm.name",
"short" : "学習群のラベル / Label for study arm",
"definition" : "この研究のこの腕のためのユニークで人間読み取り可能なラベル。 / Unique, human-readable label for this arm of the study.",
"min" : 1,
"max" : "1",
"base" : {
"path" : "ResearchStudy.arm.name",
"min" : 1,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Arm Label"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.name"
}
]
},
{
"id" : "ResearchStudy.arm.type",
"path" : "ResearchStudy.arm.type",
"short" : "研究群の分類 / Categorization of study arm",
"definition" : "研究群の分類、例えば実験的、アクティブコンパレータ、プラセボコンパレータ。 / Categorization of study arm, e.g. experimental, active comparator, placebo comparater.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.arm.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Arm Type"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.typeCode"
}
]
},
{
"id" : "ResearchStudy.arm.description",
"path" : "ResearchStudy.arm.description",
"short" : "学習経路の短い説明 / Short explanation of study path",
"definition" : "この腕に付着した主題が続く研究を通してのパスの簡潔な説明。 / A succinct description of the path through the study that would be followed by a subject adhering to this arm.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.arm.description",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "clinicaltrials-gov",
"map" : "Arm Description"
},
{
"identity" : "BRIDG5.1",
"map" : "Arm.description"
}
]
},
{
"id" : "ResearchStudy.objective",
"path" : "ResearchStudy.objective",
"short" : "研究の目標 / A goal for the study",
"definition" : "この研究が、研究中に収集されたデータの分析によって答えられる科学的な質問の観点から達成することを目指しているという目標。 / A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.",
"min" : 0,
"max" : "*",
"base" : {
"path" : "ResearchStudy.objective",
"min" : 0,
"max" : "*"
},
"type" : [
{
"code" : "BackboneElement"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyObjective"
}
]
},
{
"id" : "ResearchStudy.objective.id",
"path" : "ResearchStudy.objective.id",
"representation" : [
"xmlAttr"
],
"short" : "要素間参照のための一意のID / Unique id for inter-element referencing",
"definition" : "リソース内の要素の一意のID（内部参照用）。これは、スペースを含まない文字列値である場合があります。 / 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"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.objective.extension",
"path" : "ResearchStudy.objective.extension",
"short" : "実装で定義された追加のコンテンツ / Additional content defined by implementations",
"definition" : "要素の基本的な定義の一部ではない追加情報を表すために使用できます。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たされる一連の要件があります。 / May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.",
"comment" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "rim",
"map" : "n/a"
}
]
},
{
"id" : "ResearchStudy.objective.modifierExtension",
"path" : "ResearchStudy.objective.modifierExtension",
"short" : "認識されていなくても無視できない拡張機能 / Extensions that cannot be ignored even if unrecognized",
"definition" : "要素の基本的な定義の一部ではなく、それが含まれている要素の理解、および/または含まれる要素の子孫の理解を変更するために使用される場合があります。通常、修飾子要素は否定または資格を提供します。拡張機能を安全で管理しやすくするために、拡張機能の定義と使用に適用される厳格なガバナンスセットがあります。実装者は拡張機能を定義できますが、拡張機能の定義の一部として満たされる一連の要件があります。アプリケーションの処理リソースは、修飾子拡張機能をチェックする必要があります。\n\nモディファイア拡張は、リソースまたはdomainResource上の要素の意味を変更してはなりません（修飾軸自体の意味を変更することはできません）。 / May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment" : "拡張機能を使用または定義する機関や管轄権に関係なく、アプリケーション、プロジェクト、または標準による拡張機能の使用に関連するスティグマはありません。拡張機能の使用は、FHIR仕様がすべての人にコアレベルのシンプルさを保持できるようにするものです。 / 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" : "修飾子拡張機能により、安全に無視できる大部分の拡張機能と明確に区別できるように、安全に無視できない拡張機能が可能になります。これにより、実装者が拡張の存在を禁止する必要性を排除することにより、相互運用性が促進されます。詳細については、[修飾子拡張の定義]（拡張性.html＃modifierextension）を参照してください。 / 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](http://hl7.org/fhir/R4/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" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
},
{
"key" : "ext-1",
"severity" : "error",
"human" : "両方ではなく、拡張または値[x]が必要です / Must have either extensions or value[x], not both",
"expression" : "extension.exists() != value.exists()",
"xpath" : "exists(f:extension)!=exists(f:*[starts-with(local-name(.), \"value\")])",
"source" : "http://hl7.org/fhir/StructureDefinition/Extension"
}
],
"isModifier" : true,
"isModifierReason" : "修飾子拡張は、それらを含む要素の意味または解釈を変更することが期待されています / 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" : "ResearchStudy.objective.name",
"path" : "ResearchStudy.objective.name",
"short" : "目的のためのラベル / Label for the objective",
"definition" : "この研究のこの目的のためのユニークで人間読み取り可能なラベル。 / Unique, human-readable label for this objective of the study.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.objective.name",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "string"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "No BRIDG mapping (BRIDG has a description, but not a name)"
}
]
},
{
"id" : "ResearchStudy.objective.type",
"path" : "ResearchStudy.objective.type",
"short" : "プライマリ|セカンダリ|探索的 / primary | secondary | exploratory",
"definition" : "一種の研究目的。 / The kind of study objective.",
"min" : 0,
"max" : "1",
"base" : {
"path" : "ResearchStudy.objective.type",
"min" : 0,
"max" : "1"
},
"type" : [
{
"code" : "CodeableConcept"
}
],
"constraint" : [
{
"key" : "ele-1",
"severity" : "error",
"human" : "すべてのFHIR要素には、@valueまたは子供が必要です / All FHIR elements must have a @value or children",
"expression" : "hasValue() or (children().count() > id.count())",
"xpath" : "@value|f:*|h:div",
"source" : "http://hl7.org/fhir/StructureDefinition/Element"
}
],
"isModifier" : false,
"isSummary" : false,
"binding" : {
"extension" : [
{
"url" : "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName",
"valueString" : "ResearchStudyObjectiveType"
}
],
"strength" : "preferred",
"description" : "学習目標の種類をコードします。 / Codes for the kind of study objective.",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-objective-type"
},
"mapping" : [
{
"identity" : "BRIDG5.1",
"map" : "StudyObjective.typeCode"
}
]
}
]
},
"differential" : {
"element" : [
{
"id" : "ResearchStudy.meta.lastUpdated",
"path" : "ResearchStudy.meta.lastUpdated",
"mustSupport" : true
}
]
}
}