{ "resourceType": "StructureDefinition", "id": "biobankcy-sd-researchstudy", "url": "http://ig.biobank.cy/fhir/StructureDefinition/biobankcy-sd-researchstudy", "name": "BIOBANKCYSDResearchStudy", "title": "Profile: Research Study (biobank.cy)", "status": "draft", "publisher": "biobank.cy", "contact": [ { "name": "Molecular Medicine Research Center (MMRC)", "telecom": [ { "system": "email", "value": "biobank@ucy.ac.cy", "use": "work" } ] } ], "description": "Represents every research project that is implemented under the auspices of biobank.cy.", "fhirVersion": "4.0.1", "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": "ResearchStudy", "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-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 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" }, { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice", "valueBoolean": true }, { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation", "valueMarkdown": "When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time." } ], "key": "dom-6", "severity": "warning", "human": "A resource should have narrative for robust management", "expression": "text.`div`.exists()", "xpath": "exists(f:text/h:div)", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" }, { "key": "dom-5", "severity": "error", "human": "If a resource is contained in another resource, it SHALL NOT have a security label", "expression": "contained.meta.security.empty()", "xpath": "not(exists(f:contained/*/f:meta/f:security))", "source": "http://hl7.org/fhir/StructureDefinition/DomainResource" } ], "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": "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": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "isSummary": true }, { "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 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" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "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. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.", "comment": "Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.", "min": 0, "max": "1", "base": { "path": "Resource.implicitRules", "min": 0, "max": "1" }, "type": [ { "code": "uri" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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, "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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": "A human language.", "valueSet": "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 can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it \"clinically safe\" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.", "comment": "Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a \"text blob\" or where text is additionally entered raw or narrated and encoded information is added later.", "alias": [ "narrative", "html", "xhtml", "display" ], "min": 0, "max": "1", "base": { "path": "DomainResource.text", "min": 0, "max": "1" }, "type": [ { "code": "Narrative" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "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. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.\r\n\r\nNot to be used for biobank.cy", "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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "DomainResource.extension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "DomainResource.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them", "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": 1, "max": "1", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "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 - 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": "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.identifier.id", "path": "ResearchStudy.identifier.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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 | old (If known)", "definition": "The purpose of this identifier.", "comment": "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": 1, "max": "1", "base": { "path": "Identifier.use", "min": 0, "max": "1" }, "type": [ { "code": "code" } ], "fixedCode": "official", "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "This is labeled as \"Is Modifier\" because applications should not mistake a temporary id for a permanent one.", "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 .", "valueSet": "http://hl7.org/fhir/ValueSet/identifier-use|4.0.1" }, "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. Where 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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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.", "valueSet": "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": "Identifier.system is always case sensitive.", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.", "min": 1, "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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": "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\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start <= end)", "xpath": "not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(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.\r\n\r\nbiobank.cy: For biobank.cy research projects reference biobank.cy Organization resource.", "min": 0, "max": "1", "base": { "path": "Identifier.assigner", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 %rootResource.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" } ], "mustSupport": true, "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 SHALL NOT exceed 1MB in size", "min": 1, "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "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": "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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 %rootResource.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": "BRIDG5.1", "map": "StudyProtocolDocumentVersionPublicTitle.name" }, { "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": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "http://ig.biobank.cy/fhir/StructureDefinition/biobankcy-sd-researchstudy" ] } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 %rootResource.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" } ], "mustSupport": true, "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": "BRIDG5.1", "map": "CompanionStudyRelationship" }, { "identity": "rim", "map": ".inboundRelationship[typeCode=COMP].source[moodCode=EVN]" } ] }, { "id": "ResearchStudy.partOf.id", "path": "ResearchStudy.partOf.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.partOf.extension", "path": "ResearchStudy.partOf.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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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.partOf.reference", "path": "ResearchStudy.partOf.reference", "short": "Literal reference, Relative, internal or absolute URL", "definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.", "comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.", "min": 1, "max": "1", "base": { "path": "Reference.reference", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1", "ref-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.partOf.type", "path": "ResearchStudy.partOf.type", "short": "Type the reference refers to (e.g. \"Patient\")", "definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).", "comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.", "min": 0, "max": "1", "base": { "path": "Reference.type", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "FHIRResourceTypeExt" } ], "strength": "extensible", "description": "Aa resource (or, for logical models, the URI of the logical model).", "valueSet": "http://hl7.org/fhir/ValueSet/resource-types" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.partOf.identifier", "path": "ResearchStudy.partOf.identifier", "short": "Logical reference, when literal reference is not known", "definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.", "comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).", "min": 0, "max": "1", "base": { "path": "Reference.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "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 - 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": "rim", "map": ".identifier" } ] }, { "id": "ResearchStudy.partOf.display", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true } ], "path": "ResearchStudy.partOf.display", "short": "Text alternative for the resource", "definition": "Plain text narrative that identifies the resource in addition to the resource reference.", "comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.", "min": 0, "max": "1", "base": { "path": "Reference.display", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.status", "path": "ResearchStudy.status", "short": "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": "The current state of the study.", "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size\r\n\r\nbiobank.cy: Use the following status values: active | completed | withdrawn", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "isModifier": true, "isModifierReason": "This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid", "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyStatus" } ], "strength": "required", "description": "Codes that convey the current status of the research study.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-status|4.0.1" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "w5", "map": "FiveWs.status" }, { "identity": "BRIDG5.1", "map": "StudyOverallStatus.code" }, { "identity": "rim", "map": ".status" } ] }, { "id": "ResearchStudy.primaryPurposeType", "path": "ResearchStudy.primaryPurposeType", "short": "treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility", "definition": "The type of study based upon the intent of the study's activities. A classification of the intent 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.primaryPurposeType", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPrimaryPurposeType" } ], "strength": "extensible", "description": "Codes for the main intent of the study.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-prim-purp-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": "BRIDG5.1", "map": "StudyProtocolVersion.primaryPurposeTypeCode" } ] }, { "id": "ResearchStudy.phase", "path": "ResearchStudy.phase", "short": "n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4", "definition": "The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.", "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.phase", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyPhase" } ], "strength": "example", "description": "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": "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 Phase" }, { "identity": "BRIDG5.1", "map": "StudyProtocolVersion.phaseCode" } ] }, { "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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; 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": "Drugs, devices, etc. under study", "definition": "The 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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyFocus" } ], "strength": "example", "description": "Codes for medications, devices 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": "Focus of Study" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "BRIDG5.1", "map": "InterventionalStudyProtocol.interventionTypeCode" } ] }, { "id": "ResearchStudy.condition", "path": "ResearchStudy.condition", "short": "Condition being studied", "definition": "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.", "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.condition", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ConditionCode" } ], "strength": "example", "description": "Identification of the condition or diagnosis.", "valueSet": "http://hl7.org/fhir/ValueSet/condition-code" }, "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" }, { "identity": "w5", "map": "FiveWs.what[x]" }, { "identity": "BRIDG5.1", "map": "StudyCondition.code" } ] }, { "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "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" }, { "identity": "BRIDG5.1", "map": "PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion" } ] }, { "id": "ResearchStudy.contact.id", "path": "ResearchStudy.contact.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.contact.extension", "path": "ResearchStudy.contact.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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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.contact.name", "path": "ResearchStudy.contact.name", "short": "Name of an individual to contact", "definition": "The name of an individual to contact.", "comment": "If there is no named individual, the telecom information is for the organization as a whole.", "min": 0, "max": "1", "base": { "path": "ContactDetail.name", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.contact.telecom", "path": "ResearchStudy.contact.telecom", "short": "Contact details for individual or organization", "definition": "The contact details for the individual (if a name was provided) or the organization.", "min": 0, "max": "*", "base": { "path": "ContactDetail.telecom", "min": 0, "max": "*" }, "type": [ { "code": "ContactPoint" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "cpt-2", "severity": "error", "human": "A system is required if a value is provided.", "expression": "value.empty() or system.exists()", "xpath": "not(exists(f:value)) or exists(f:system)", "source": "http://hl7.org/fhir/StructureDefinition/ContactPoint" } ], "mustSupport": true, "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "XTN" }, { "identity": "rim", "map": "TEL" }, { "identity": "servd", "map": "ContactPoint" } ] }, { "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Citations, Links, Available Study Data/Documents" }, { "identity": "BRIDG5.1", "map": "StudyProtocolDocument, StudyProtocolDocumentVersion" } ] }, { "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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" }, { "identity": "BRIDG5.1", "map": "DocumentVersion.keywordCode; DocumentVersion.keywordText" } ] }, { "id": "ResearchStudy.location", "path": "ResearchStudy.location", "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.location", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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.", "valueSet": "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" }, { "identity": "BRIDG5.1", "map": "StudyProtocolVersion.participatingLocationCode" } ] }, { "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, so the text should be readable without markdown processing. The markdown syntax is GFM - see https://github.github.com/gfm/", "min": 1, "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mustSupport": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Detailed Description" }, { "identity": "BRIDG5.1", "map": "StudyProtocolDocumentVersion.publicDescription" } ] }, { "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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 %rootResource.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": "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": "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": "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\").\n\nPeriod is not used for a duration (a measure of elapsed time). See [Duration](datatypes.html#Duration).", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "key": "per-1", "severity": "error", "human": "If present, start SHALL have a lower value than end", "expression": "start.hasValue().not() or end.hasValue().not() or (start <= end)", "xpath": "not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))", "source": "http://hl7.org/fhir/StructureDefinition/Period" } ], "mustSupport": true, "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": "FiveWs.done[x]" }, { "identity": "BRIDG5.1", "map": "ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration" }, { "identity": "rim", "map": ".effectiveTime" } ] }, { "id": "ResearchStudy.sponsor", "path": "ResearchStudy.sponsor", "short": "Organization that initiates and is legally responsible for the study", "definition": "An organization that initiates the investigation and is legally responsible for 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.\r\n\r\nNot to be used for biobank.cy", "min": 0, "max": "1", "base": { "path": "ResearchStudy.sponsor", "min": 0, "max": "1" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Organization" ] } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 %rootResource.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": "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": "Researcher who oversees multiple aspects of the study", "definition": "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.", "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": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://ig.biobank.cy/fhir/StructureDefinition/biobankcy-sd-practitioner" ] } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 %rootResource.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" } ], "mustSupport": true, "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": "FiveWs.actor" }, { "identity": "BRIDG5.1", "map": "StudyInvestigator" } ] }, { "id": "ResearchStudy.principalInvestigator.id", "path": "ResearchStudy.principalInvestigator.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.principalInvestigator.extension", "path": "ResearchStudy.principalInvestigator.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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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.principalInvestigator.reference", "path": "ResearchStudy.principalInvestigator.reference", "short": "Literal reference, Relative, internal or absolute URL", "definition": "A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.", "comment": "Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure \"/[type]/[id]\" then it should be assumed that the reference is to a FHIR RESTful server.", "min": 1, "max": "1", "base": { "path": "Reference.reference", "min": 0, "max": "1" }, "type": [ { "code": "string" } ], "condition": [ "ele-1", "ref-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.principalInvestigator.type", "path": "ResearchStudy.principalInvestigator.type", "short": "Type the reference refers to (e.g. \"Patient\")", "definition": "The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.\n\nThe type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. \"Patient\" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).", "comment": "This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified.", "min": 0, "max": "1", "base": { "path": "Reference.type", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "FHIRResourceTypeExt" } ], "strength": "extensible", "description": "Aa resource (or, for logical models, the URI of the logical model).", "valueSet": "http://hl7.org/fhir/ValueSet/resource-types" }, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.principalInvestigator.identifier", "path": "ResearchStudy.principalInvestigator.identifier", "short": "Logical reference, when literal reference is not known", "definition": "An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.", "comment": "When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. \n\nWhen both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference\n\nApplications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.\n\nReference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).", "min": 0, "max": "1", "base": { "path": "Reference.identifier", "min": 0, "max": "1" }, "type": [ { "code": "Identifier" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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" } ], "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 - 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": "rim", "map": ".identifier" } ] }, { "id": "ResearchStudy.principalInvestigator.display", "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable", "valueBoolean": true } ], "path": "ResearchStudy.principalInvestigator.display", "short": "Text alternative for the resource", "definition": "Plain text narrative that identifies the resource in addition to the resource reference.", "comment": "This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.", "min": 0, "max": "1", "base": { "path": "Reference.display", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.site", "path": "ResearchStudy.site", "short": "Facility where study activities are conducted", "definition": "A facility in which study activities are conducted.", "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.\r\n\r\nNot to be used for biobank.cy", "min": 0, "max": "*", "base": { "path": "ResearchStudy.site", "min": 0, "max": "*" }, "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Location" ] } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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 %rootResource.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": "FiveWs.where[x]" }, { "identity": "BRIDG5.1", "map": "PlannedStudySite; StudySite" } ] }, { "id": "ResearchStudy.reasonStopped", "path": "ResearchStudy.reasonStopped", "short": "accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design", "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.\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "isSummary": true, "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyReasonStopped" } ], "strength": "example", "description": "Codes for why the study ended prematurely.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-reason-stopped" }, "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": "FiveWs.why[x]" }, { "identity": "BRIDG5.1", "map": "StudyOverallStatus.studyStoppedReasonCode" } ] }, { "id": "ResearchStudy.note", "path": "ResearchStudy.note", "short": "Comments made about the study", "definition": "Comments made about the study 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).\r\n\r\nNot to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "v2", "map": "N/A" }, { "identity": "rim", "map": "Act" }, { "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": "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.", "comment": "Not to be used for biobank.cy", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arms" }, { "identity": "BRIDG5.1", "map": "Arm" } ] }, { "id": "ResearchStudy.arm.id", "path": "ResearchStudy.arm.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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 even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "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 SHALL 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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arm Label" }, { "identity": "BRIDG5.1", "map": "Arm.name" } ] }, { "id": "ResearchStudy.arm.type", "path": "ResearchStudy.arm.type", "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.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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "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" }, { "identity": "BRIDG5.1", "map": "Arm.typeCode" } ] }, { "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 SHALL 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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "clinicaltrials-gov", "map": "Arm Description" }, { "identity": "BRIDG5.1", "map": "Arm.description" } ] }, { "id": "ResearchStudy.objective", "path": "ResearchStudy.objective", "short": "A goal for the study", "definition": "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.", "comment": "Not to be used for biobank.cy", "min": 0, "max": "*", "base": { "path": "ResearchStudy.objective", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "BRIDG5.1", "map": "StudyObjective" } ] }, { "id": "ResearchStudy.objective.id", "path": "ResearchStudy.objective.id", "representation": [ "xmlAttr" ], "short": "Unique id for inter-element referencing", "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.", "min": 0, "max": "1", "base": { "path": "Element.id", "min": 0, "max": "1" }, "type": [ { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type", "valueUrl": "string" } ], "code": "http://hl7.org/fhirpath/System.String" } ], "mapping": [ { "identity": "rim", "map": "n/a" } ] }, { "id": "ResearchStudy.objective.extension", "path": "ResearchStudy.objective.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. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.", "comment": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "alias": [ "extensions", "user content" ], "min": 0, "max": "*", "base": { "path": "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" }, { "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.objective.modifierExtension", "path": "ResearchStudy.objective.modifierExtension", "short": "Extensions that cannot be ignored even if unrecognized", "definition": "May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and 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": "There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.", "requirements": "Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](extensibility.html#modifierExtension).", "alias": [ "extensions", "user content", "modifiers" ], "min": 0, "max": "*", "base": { "path": "BackboneElement.modifierExtension", "min": 0, "max": "*" }, "type": [ { "code": "Extension" } ], "condition": [ "ele-1" ], "constraint": [ { "key": "ele-1", "severity": "error", "human": "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": "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": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them", "isSummary": true, "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "rim", "map": "N/A" } ] }, { "id": "ResearchStudy.objective.name", "path": "ResearchStudy.objective.name", "short": "Label for the objective", "definition": "Unique, human-readable label for this objective of the study.", "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size", "min": 0, "max": "1", "base": { "path": "ResearchStudy.objective.name", "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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "mapping": [ { "identity": "rim", "map": "n/a" }, { "identity": "BRIDG5.1", "map": "No BRIDG mapping (BRIDG has a description, but not a name)" } ] }, { "id": "ResearchStudy.objective.type", "path": "ResearchStudy.objective.type", "short": "primary | secondary | exploratory", "definition": "The kind of study objective.", "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.objective.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() or (children().count() > id.count())", "xpath": "@value|f:*|h:div", "source": "http://hl7.org/fhir/StructureDefinition/Element" } ], "binding": { "extension": [ { "url": "http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName", "valueString": "ResearchStudyObjectiveType" } ], "strength": "preferred", "description": "Codes for the kind of study objective.", "valueSet": "http://hl7.org/fhir/ValueSet/research-study-objective-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": "BRIDG5.1", "map": "StudyObjective.typeCode" } ] } ] }, "differential": { "element": [ { "id": "ResearchStudy.contained", "path": "ResearchStudy.contained", "comment": "This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.identifier", "path": "ResearchStudy.identifier", "min": 1, "max": "1", "mustSupport": true }, { "id": "ResearchStudy.identifier.use", "path": "ResearchStudy.identifier.use", "min": 1, "fixedCode": "official" }, { "id": "ResearchStudy.identifier.value", "path": "ResearchStudy.identifier.value", "min": 1 }, { "id": "ResearchStudy.identifier.assigner", "path": "ResearchStudy.identifier.assigner", "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.\r\n\r\nbiobank.cy: For biobank.cy research projects reference biobank.cy Organization resource.", "mustSupport": true }, { "id": "ResearchStudy.title", "path": "ResearchStudy.title", "min": 1, "mustSupport": true }, { "id": "ResearchStudy.protocol", "path": "ResearchStudy.protocol", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.partOf", "path": "ResearchStudy.partOf", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/ResearchStudy", "http://ig.biobank.cy/fhir/StructureDefinition/biobankcy-sd-researchstudy" ] } ], "mustSupport": true }, { "id": "ResearchStudy.partOf.reference", "path": "ResearchStudy.partOf.reference", "min": 1 }, { "id": "ResearchStudy.status", "path": "ResearchStudy.status", "comment": "Note that FHIR strings SHALL NOT exceed 1MB in size\r\n\r\nbiobank.cy: Use the following status values: active | completed | withdrawn", "mustSupport": true }, { "id": "ResearchStudy.category", "path": "ResearchStudy.category", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.focus", "path": "ResearchStudy.focus", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.condition", "path": "ResearchStudy.condition", "mustSupport": true }, { "id": "ResearchStudy.contact", "path": "ResearchStudy.contact", "mustSupport": true }, { "id": "ResearchStudy.contact.name", "path": "ResearchStudy.contact.name", "mustSupport": true }, { "id": "ResearchStudy.contact.telecom", "path": "ResearchStudy.contact.telecom", "mustSupport": true }, { "id": "ResearchStudy.relatedArtifact", "path": "ResearchStudy.relatedArtifact", "comment": "Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.keyword", "path": "ResearchStudy.keyword", "definition": "Key terms to aid in searching for or filtering the study.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.description", "path": "ResearchStudy.description", "min": 1, "mustSupport": true }, { "id": "ResearchStudy.enrollment", "path": "ResearchStudy.enrollment", "comment": "The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.period", "path": "ResearchStudy.period", "mustSupport": true }, { "id": "ResearchStudy.sponsor", "path": "ResearchStudy.sponsor", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.principalInvestigator", "path": "ResearchStudy.principalInvestigator", "type": [ { "code": "Reference", "targetProfile": [ "http://hl7.org/fhir/StructureDefinition/Practitioner", "http://hl7.org/fhir/StructureDefinition/PractitionerRole", "http://ig.biobank.cy/fhir/StructureDefinition/biobankcy-sd-practitioner" ] } ], "mustSupport": true }, { "id": "ResearchStudy.principalInvestigator.reference", "path": "ResearchStudy.principalInvestigator.reference", "min": 1 }, { "id": "ResearchStudy.site", "path": "ResearchStudy.site", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.reasonStopped", "path": "ResearchStudy.reasonStopped", "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.\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.note", "path": "ResearchStudy.note", "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).\r\n\r\nNot to be used for biobank.cy" }, { "id": "ResearchStudy.arm", "path": "ResearchStudy.arm", "comment": "Not to be used for biobank.cy" }, { "id": "ResearchStudy.objective", "path": "ResearchStudy.objective", "comment": "Not to be used for biobank.cy" } ] } }