{ "resourceType": "StructureDefinition", "url": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1", "version": "1.0.0", "name": "CareConnect-ResearchStudy-1", "status": "draft", "date": "2019-03-01T13:34:00.74+00:00", "publisher": "NHS Digital", "contact": [ { "name": "Interoperability Team", "telecom": [ { "system": "email", "value": "interoperabilityteam@nhs.net", "use": "work" } ] } ], "description": "A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.", "purpose": "[NOT CURATED BY INTEROPEN see: http://www.interopen.org/careconnect-curation-methodology/] Initial development for the Digital Maternity programme", "copyright": "Copyright © 2016 HL7 UK\r \r Licensed under the Apache License, Version 2.0 (the \"License\"); you may not use this file except in compliance with the License. You may obtain a copy of the License at\r \r http://www.apache.org/licenses/LICENSE-2.0\r \r Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an \"AS IS\" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License.\r \r HL7® FHIR® standard Copyright © 2011+ HL7\r \r The HL7® FHIR® standard is used under the FHIR license. You may obtain a copy of the FHIR license at\r \r https://www.hl7.org/fhir/license.html", "fhirVersion": "3.0.2", "kind": "resource", "abstract": false, "type": "ResearchStudy", "baseDefinition": "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "derivation": "constraint", "snapshot": { "element": [ { "id": "ResearchStudy", "path": "ResearchStudy", "short": "Investigation to increase healthcare-related patient-independent knowledge", "definition": "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": "Need to make sure we encompass public health studies.", "alias": [ "Clinical Trial", "Study" ], "min": 0, "max": "*", "base": { "path": "Resource", "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": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-1", "severity": "error", "human": "If the resource is contained in another resource, it SHALL NOT contain any narrative", "expression": "contained.text.empty()", "xpath": "not(parent::f:contained and f:text)", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-4", "severity": "error", "human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated", "expression": "contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()", "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-3", "severity": "error", "human": "If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource", "expression": "contained.where(('#'+id in %resource.descendants().reference).not()).empty()", "xpath": "not(exists(for $id in f:contained/*/@id return $id[not(ancestor::f:contained/parent::*/descendant::f:reference/@value=concat('#', $id))]))", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" } ], "mapping": [ { "identity": "rim", "map": "Entity. Role, or Act" }, { "identity": "v2", "map": "OBX" }, { "identity": "rim", "map": "Observation[classCode=CLNTRL, moodCode=EVN]" }, { "identity": "w5", "map": "clinical.diagnostics" } ] }, { "id": "ResearchStudy.id", "path": "ResearchStudy.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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.meta", "path": "ResearchStudy.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 may 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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.implicitRules", "path": "ResearchStudy.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.", "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. \n\nThis element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.", "min": 0, "max": "1", "base": { "path": "Resource.implicitRules", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isModifier": true, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.language", "path": "ResearchStudy.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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet", "valueReference": { "reference": "http://hl7.org/fhir/ValueSet/all-languages" } }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Language" } ], "strength": "extensible", "description": "A human language.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/languages" } }, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.text", "path": "ResearchStudy.text", "short": "Text summary of the resource, for human interpretation", "definition": "A human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.", "comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded in formation is added later.", "alias": [ "narrative", "html", "xhtml", "display" ], "min": 0, "max": "1", "base": { "path": "DomainResource.text", "min": 0, "max": "1" }, "type": [ { "code": "Narrative" } ], "condition": [ "ele-1", "dom-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" }, { "identity": "rim", "map": "Act.text?" } ] }, { "id": "ResearchStudy.contained", "path": "ResearchStudy.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.", "alias": [ "inline resources", "anonymous resources", "contained resources" ], "min": 0, "max": "*", "base": { "path": "DomainResource.contained", "min": 0, "max": "*" }, "type": [ { "code": "Resource" } ], "mapping": [ { "identity": "rim", "map": "Entity. Role, or Act" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.extension", "path": "ResearchStudy.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.modifierExtension", "path": "ResearchStudy.modifierExtension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.", "comment": "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.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.identifier", "path": "ResearchStudy.identifier", "short": "Business Identifier for study", "definition": "Identifiers assigned to this research study by the sponsor or other systems.", "requirements": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX / EI (occasionally, more often EI maps to a resource id or a URL)" }, { "identity": "rim", "map": "II - see see identifier pattern at http://wiki.hl7.org/index.php?title=Common_Design_Patterns#Identifier_Pattern for relevant discussion. The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]" }, { "identity": "servd", "map": "Identifier" }, { "identity": "clinicaltrials-gov", "map": "Organization's Unique Protocol ID; Secondary IDs" }, { "identity": "rim", "map": ".identifier" }, { "identity": "w5", "map": "id" } ] }, { "id": "ResearchStudy.identifier.id", "path": "ResearchStudy.identifier.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.identifier.extension", "path": "ResearchStudy.identifier.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional Content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.identifier.use", "path": "ResearchStudy.identifier.use", "short": "usual | official | temp | secondary (If known)", "definition": "The purpose of this identifier.", "comment": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.", "requirements": "Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.", "min": 0, "max": "1", "base": { "path": "Identifier.use", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isModifier": true, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "IdentifierUse" } ], "strength": "required", "description": "Identifies the purpose for this identifier, if known .", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/identifier-use" } }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Role.code or implied by context" } ] }, { "id": "ResearchStudy.identifier.type", "path": "ResearchStudy.identifier.type", "short": "Description of identifier", "definition": "A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.", "comment": "This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. \n\nWhere the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.", "requirements": "Allows users to make use of identifiers when the identifier system is not known.", "min": 0, "max": "1", "base": { "path": "Identifier.type", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "IdentifierType" } ], "strength": "extensible", "description": "A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/identifier-type" } }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "v2", "map": "CX.5" }, { "identity": "rim", "map": "Role.code or implied by context" } ] }, { "id": "ResearchStudy.identifier.system", "path": "ResearchStudy.identifier.system", "short": "The namespace for the identifier value", "definition": "Establishes the namespace for the value - that is, a URL that describes a set values that are unique.", "comment": "see http://en.wikipedia.org/wiki/Uniform_resource_identifier", "requirements": "There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.", "min": 0, "max": "1", "base": { "path": "Identifier.system", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "example": [ { "label": "General", "valueUri": "http://www.acme.com/identifiers/patient" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX.4 / EI-2-4" }, { "identity": "rim", "map": "II.root or Role.id.root" }, { "identity": "servd", "map": "./IdentifierType" } ] }, { "id": "ResearchStudy.identifier.value", "path": "ResearchStudy.identifier.value", "short": "The value that is unique", "definition": "The portion of the identifier typically relevant to the user and which is unique within the context of the system.", "comment": "If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](extension-rendered-value.html).", "min": 0, "max": "1", "base": { "path": "Identifier.value", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "example": [ { "label": "General", "valueString": "123456" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CX.1 / EI.1" }, { "identity": "rim", "map": "II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)" }, { "identity": "servd", "map": "./Value" } ] }, { "id": "ResearchStudy.identifier.period", "path": "ResearchStudy.identifier.period", "short": "Time period when id is/was valid for use", "definition": "Time period during which identifier is/was valid for use.", "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.", "min": 0, "max": "1", "base": { "path": "Identifier.period", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Period" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower value than end", "expression": "start.empty() or end.empty() or (start <= end)", "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" }, { "identity": "v2", "map": "CX.7 + CX.8" }, { "identity": "rim", "map": "Role.effectiveTime or implied by context" }, { "identity": "servd", "map": "./StartDate and ./EndDate" } ] }, { "id": "ResearchStudy.identifier.assigner", "path": "ResearchStudy.identifier.assigner", "short": "Organization that issued id (may be just text)", "definition": "Organization that issued/manages the identifier.", "comment": "The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.", "min": 0, "max": "1", "base": { "path": "Identifier.assigner", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "v2", "map": "CX.4 / (CX.4,CX.9,CX.10)" }, { "identity": "rim", "map": "II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper" }, { "identity": "servd", "map": "./IdentifierIssuingAuthority" } ] }, { "id": "ResearchStudy.title", "path": "ResearchStudy.title", "short": "Name for this study", "definition": "A short, descriptive user-friendly label for the study.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "ResearchStudy.title", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Brief Title" } ] }, { "id": "ResearchStudy.protocol", "path": "ResearchStudy.protocol", "short": "Steps followed in executing study", "definition": "The set of steps expected to be performed as part of the execution of the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.protocol", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": "http://hl7.org/fhir/StructureDefinition/PlanDefinition" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "clinicaltrials-gov", "map": "Interventions; Arm/Intervention Cross-Reference" }, { "identity": "rim", "map": ".outboundRelationship[typeCode=DEFN].target" } ] }, { "id": "ResearchStudy.partOf", "path": "ResearchStudy.partOf", "short": "Part of larger study", "definition": "A larger research study of which this particular study is a component or step.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "requirements": "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": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "rim", "map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" } ] }, { "id": "ResearchStudy.status", "path": "ResearchStudy.status", "short": "draft | in-progress | suspended | stopped | completed | entered-in-error", "definition": "The current state of the study.", "comment": "This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.", "min": 1, "max": "1", "base": { "path": "ResearchStudy.status", "min": 1, "max": "1" }, "type": [ { "code": "code" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isModifier": true, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyStatus" } ], "strength": "required", "description": "Codes that convey the current status of the research study", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/research-study-status" } }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": ".status" }, { "identity": "w5", "map": "status" } ] }, { "id": "ResearchStudy.category", "path": "ResearchStudy.category", "short": "Classifications for the study", "definition": "Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.category", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyCategory" } ], "strength": "example", "description": "Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc." }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "clinicaltrials-gov", "map": "Study Type; Primary Purpose; Study Phase; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention" } ] }, { "id": "ResearchStudy.focus", "path": "ResearchStudy.focus", "short": "Drugs, devices, conditions, etc. under study", "definition": "The condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.focus", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyFocus" } ], "strength": "example", "description": "Codes for medications, devices, conditions and other interventions" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "clinicaltrials-gov", "map": "Conditions or Focus of Study" }, { "identity": "w5", "map": "what" } ] }, { "id": "ResearchStudy.contact", "path": "ResearchStudy.contact", "short": "Contact details for the study", "definition": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators" } ] }, { "id": "ResearchStudy.relatedArtifact", "path": "ResearchStudy.relatedArtifact", "short": "References and dependencies", "definition": "Citations, references and other related documents.", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.relatedArtifact", "min": 0, "max": "*" }, "type": [ { "code": "RelatedArtifact" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Citations, Links, Available Study Data/Documents" } ] }, { "id": "ResearchStudy.keyword", "path": "ResearchStudy.keyword", "short": "Used to search for the study", "definition": "Key terms to aid in searching for or filtering the study.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.keyword", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyKeyword" } ], "strength": "example", "description": "Words associated with the study that may be useful in discovery" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "clinicaltrials-gov", "map": "Keywords" } ] }, { "id": "ResearchStudy.jurisdiction", "path": "ResearchStudy.jurisdiction", "short": "Geographic region(s) for study", "definition": "Indicates a country, state or other region where the study is taking place.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.jurisdiction", "min": 0, "max": "*" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "Jurisdiction" } ], "strength": "extensible", "description": "Countries and regions within which this artifact is targeted for use", "valueSetReference": { "reference": "http://hl7.org/fhir/ValueSet/jurisdiction" } }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" } ] }, { "id": "ResearchStudy.description", "path": "ResearchStudy.description", "short": "What this is study doing", "definition": "A full description of how the study is being conducted.", "comment": "Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip)", "min": 0, "max": "1", "base": { "path": "ResearchStudy.description", "min": 0, "max": "1" }, "type": [ { "code": "markdown" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Detailed Description" } ] }, { "id": "ResearchStudy.enrollment", "path": "ResearchStudy.enrollment", "short": "Inclusion & exclusion criteria", "definition": "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": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "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": "who.focus" } ] }, { "id": "ResearchStudy.period", "path": "ResearchStudy.period", "short": "When the study began and ended", "definition": "Identifies the start date and the expected (or actual, depending on status) end date for the study.", "comment": "This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. \"the patient was an inpatient of the hospital for this time range\") or one value from the range applies (e.g. \"give to the patient between these two times\"). If duration is required, specify the type as Interval|Duration.", "requirements": "[The list of types may be constrained as appropriate for the type of event].", "alias": [ "timing" ], "min": 0, "max": "1", "base": { "path": "ResearchStudy.period", "min": 0, "max": "1" }, "type": [ { "code": "Period" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Period" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower value than end", "expression": "start.empty() or end.empty() or (start <= end)", "xpath": "not(exists(f:start)) or not(exists(f:end)) or (f:start/@value <= f:end/@value)", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "DR" }, { "identity": "rim", "map": "IVL[lowClosed=\"true\" and highClosed=\"true\"] or URG[lowClosed=\"true\" and highClosed=\"true\"]" }, { "identity": "clinicaltrials-gov", "map": "Study Start Date (start); Study Completion Date (end)" }, { "identity": "w5", "map": "when.done" } ] }, { "id": "ResearchStudy.sponsor", "path": "ResearchStudy.sponsor", "short": "Organization responsible for the study", "definition": "The organization responsible for the execution of the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "1", "base": { "path": "ResearchStudy.sponsor", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "clinicaltrials-gov", "map": "Sponsor" }, { "identity": "w5", "map": "who.actor" } ] }, { "id": "ResearchStudy.principalInvestigator", "path": "ResearchStudy.principalInvestigator", "short": "The individual responsible for the study", "definition": "Indicates the individual who has primary oversite of the execution of the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "1", "base": { "path": "ResearchStudy.principalInvestigator", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "clinicaltrials-gov", "map": "Principal Investigator" }, { "identity": "w5", "map": "who.actor" } ] }, { "id": "ResearchStudy.site", "path": "ResearchStudy.site", "short": "Location involved in study execution", "definition": "Clinic, hospital or other healthcare location that is participating in the study.", "comment": "References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.", "min": 0, "max": "*", "base": { "path": "ResearchStudy.site", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Location-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Reference" }, { "key": "ref-1", "severity": "error", "human": "SHALL have a contained resource if a local reference is provided", "expression": "reference.startsWith('#').not() or (reference.substring(1).trace('url') in %resource.contained.id.trace('ids'))", "xpath": "not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])", "source": "http://hl7.org/fhir/StructureDefinition/Reference" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "The target of a resource reference is a RIM entry point (Act, Role, or Entity)" }, { "identity": "clinicaltrials-gov", "map": "Facility" }, { "identity": "w5", "map": "where" } ] }, { "id": "ResearchStudy.reasonStopped", "path": "ResearchStudy.reasonStopped", "short": "Reason for terminating study early", "definition": "A description and/or code explaining the premature termination of the study.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "1", "base": { "path": "ResearchStudy.reasonStopped", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "clinicaltrials-gov", "map": "Why Study Stopped" }, { "identity": "w5", "map": "why" } ] }, { "id": "ResearchStudy.note", "path": "ResearchStudy.note", "short": "Comments made about the event", "definition": "Comments made about the event by the performer, subject or other participants.", "comment": "For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. *Annotations SHOULD NOT* be used to communicate \"modifying\" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).", "min": 0, "max": "*", "base": { "path": "ResearchStudy.note", "min": 0, "max": "*" }, "type": [ { "code": "Annotation" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act" } ] }, { "id": "ResearchStudy.note.id", "path": "ResearchStudy.note.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.note.extension", "path": "ResearchStudy.note.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional Content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.note.author[x]", "path": "ResearchStudy.note.author[x]", "short": "Individual responsible for the annotation", "definition": "The individual responsible for making the annotation.", "min": 0, "max": "1", "base": { "path": "Annotation.author[x]", "min": 0, "max": "1" }, "type": [ { "code": "string" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Patient-1" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-RelatedPerson-1" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act.participant[typeCode=AUT].role" } ] }, { "id": "ResearchStudy.note.time", "path": "ResearchStudy.note.time", "short": "When the annotation was made", "definition": "Indicates when this particular annotation was made.", "min": 0, "max": "1", "base": { "path": "Annotation.time", "min": 0, "max": "1" }, "type": [ { "code": "dateTime" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act.effectiveTime" } ] }, { "id": "ResearchStudy.note.text", "path": "ResearchStudy.note.text", "short": "The annotation - text content", "definition": "The text of the annotation.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 1, "max": "1", "base": { "path": "Annotation.text", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act.text" } ] }, { "id": "ResearchStudy.arm", "path": "ResearchStudy.arm", "short": "Defined path through the study for a subject", "definition": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arms" } ] }, { "id": "ResearchStudy.arm.id", "path": "ResearchStudy.arm.id", "representation": [ "xmlAttr" ], "short": "xml:id (or equivalent in JSON)", "definition": "unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.arm.extension", "path": "ResearchStudy.arm.extension", "slicing": { "discriminator": [ { "type": "value", "path": "url" } ], "description": "Extensions are always sliced by (at least) url", "rules": "open" }, "short": "Additional Content defined by implementations", "definition": "May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.arm.modifierExtension", "path": "ResearchStudy.arm.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 element, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.", "comment": "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", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Extension" }, { "key": "ext-1", "severity": "error", "human": "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, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.arm.name", "path": "ResearchStudy.arm.name", "short": "Label for study arm", "definition": "Unique, human-readable label for this arm of the study.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 1, "max": "1", "base": { "path": "ResearchStudy.arm.name", "min": 1, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arm Label" } ] }, { "id": "ResearchStudy.arm.code", "path": "ResearchStudy.arm.code", "short": "Categorization of study arm", "definition": "Categorization of study arm, e.g. experimental, active comparator, placebo comparater.", "comment": "Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.", "min": 0, "max": "1", "base": { "path": "ResearchStudy.arm.code", "min": 0, "max": "1" }, "type": [ { "code": "CodeableConcept" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "CE/CNE/CWE" }, { "identity": "rim", "map": "CD" }, { "identity": "orim", "map": "fhir:CodeableConcept rdfs:subClassOf dt:CD" }, { "identity": "clinicaltrials-gov", "map": "Arm Type" } ] }, { "id": "ResearchStudy.arm.description", "path": "ResearchStudy.arm.description", "short": "Short explanation of study path", "definition": "A succinct description of the path through the study that would be followed by a subject adhering to this arm.", "comment": "Note that FHIR strings may not exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "ResearchStudy.arm.description", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "All FHIR elements must have a @value or children", "expression": "hasValue() | (children().count() > id.count())", "xpath": "@value|f:*|h:div" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arm Description" } ] } ] }, "differential": { "element": [ { "id": "ResearchStudy.identifier.assigner", "path": "ResearchStudy.identifier.assigner", "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1" } ] }, { "id": "ResearchStudy.partOf", "path": "ResearchStudy.partOf", "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-ResearchStudy-1" } ] }, { "id": "ResearchStudy.sponsor", "path": "ResearchStudy.sponsor", "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Organization-1" } ] }, { "id": "ResearchStudy.principalInvestigator", "path": "ResearchStudy.principalInvestigator", "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1" } ] }, { "id": "ResearchStudy.site", "path": "ResearchStudy.site", "type": [ { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Location-1" } ] }, { "id": "ResearchStudy.note.author[x]", "path": "ResearchStudy.note.author[x]", "type": [ { "code": "string" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Patient-1" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-Practitioner-1" }, { "code": "Reference", "targetProfile": "https://fhir.hl7.org.uk/STU3/StructureDefinition/CareConnect-RelatedPerson-1" } ] } ] } }