Overview
The below overview shows the elements of the resource, data type and the cardinality of each. Further details like "Binding"/"Fixed values"/"contraints" etc can be found on clicking on each element.
Canonical URL - http://roche.com/fhir/rdc/StructureDefinition/researchstudy
| researchstudy (ResearchStudy) | C | ResearchStudy | There are no (further) constraints on this element Element idResearchStudyShort description Investigation to increase healthcare-related patient-independent knowledge Alternate namesClinical Trial, Study DefinitionA 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. Need to make sure we encompass public health studies.
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| id | Σ | 0..1 | id | There are no (further) constraints on this element Element idResearchStudy.idShort description Logical id of this artifact DefinitionThe logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| meta | Σ | 0..1 | Meta | There are no (further) constraints on this element Element idResearchStudy.metaShort description Metadata about the resource DefinitionThe metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| implicitRules | Σ ?! | 0..1 | uri | There are no (further) constraints on this element Element idResearchStudy.implicitRulesShort description A set of rules under which this content was created DefinitionA reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. 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. This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| language | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.languageShort description Language of the resource content DefinitionThe base language in which the resource is written. 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). A human language. Binding extensions
The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| text | C | 0..1 | Narrative | There are no (further) constraints on this element Element idResearchStudy.textShort description Text summary of the resource, for human interpretation Alternate namesnarrative, html, xhtml, display DefinitionA human-readable narrative that contains a summary of the resource, and may be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety. Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded in formation is added later. The cardinality or value of this element may be affected by these constraints: ele-1, dom-1 Constraints
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| contained | 0..* | Resource | There are no (further) constraints on this element Element idResearchStudy.containedShort description Contained, inline Resources Alternate namesinline resources, anonymous resources, contained resources DefinitionThese 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. 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.
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.extensionShort description Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| modifierExtension | ?! C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.modifierExtensionShort description Extensions that cannot be ignored Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the resource, and that modifies the understanding of the element that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| identifier | Σ | 1..1 | Identifier | There are no (further) constraints on this element Element idResearchStudy.identifierShort description Business Identifier for study DefinitionIdentifiers assigned to this research study by the sponsor or other systems. Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.idShort description xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.identifier.extensionShort description Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| use | Σ ?! | 0..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.useShort description usual | official | temp | secondary (If known) DefinitionThe purpose of this identifier. Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers. This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one. Applications can assume that an identifier is permanent unless it explicitly says that it is temporary. Identifies the purpose for this identifier, if known . ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| type | Σ | 0..1 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.identifier.typeShort description Description of identifier DefinitionA coded type for the identifier that can be used to determine which identifier to use for a specific purpose. Allows users to make use of identifiers when the identifier system is not known. 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. A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. Identifier Type Codes (extensible) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| system | Σ | 0..1 | uriBinding | Element idResearchStudy.identifier.systemShort description The namespace for the identifier value DefinitionEstablishes the namespace for the value - that is, a URL that describes a set values that are unique. 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. see http://en.wikipedia.org/wiki/Uniform_resource_identifier The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
General http://www.acme.com/identifiers/patientMappings
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| value | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.identifier.valueShort description The value that is unique DefinitionThe portion of the identifier typically relevant to the user and which is unique within the context of the system. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
General 123456Mappings
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| period | Σ C | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.identifier.periodShort description Time period when id is/was valid for use DefinitionTime period during which identifier is/was valid for use. This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval|Duration. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| assigner | Σ C | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.identifier.assignerShort description Organization that issued id (may be just text) DefinitionOrganization that issued/manages the identifier. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| title | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.titleShort description Name for this study DefinitionA short, descriptive user-friendly label for the study. Note that FHIR strings may not exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| protocol | Σ C | 0..0 | Reference(PlanDefinition) | There are no (further) constraints on this element Element idResearchStudy.protocolShort description Steps followed in executing study DefinitionThe set of steps expected to be performed as part of the execution of the study. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| partOf | Σ C | 0..0 | Reference(ResearchStudy) | There are no (further) constraints on this element Element idResearchStudy.partOfShort description Part of larger study Alternate namescontainer DefinitionA larger research study of which this particular study is a component or step. Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| status | Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element idResearchStudy.statusShort description draft | in-progress | suspended | stopped | completed | entered-in-error DefinitionThe current state of the study. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Codes that convey the current status of the research study ResearchStudyStatus (required) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| category | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.categoryShort description Classifications for the study DefinitionCodes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc. 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. Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| focus | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.focusShort description Drugs, devices, conditions, etc. under study DefinitionThe condition(s), medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about. 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. Codes for medications, devices, conditions and other interventions ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| contact | Σ | 0..0 | ContactDetail | There are no (further) constraints on this element Element idResearchStudy.contactShort description Contact details for the study DefinitionContact details to assist a user in learning more about or engaging with the study. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| relatedArtifact | 0..0 | RelatedArtifact | There are no (further) constraints on this element Element idResearchStudy.relatedArtifactShort description References and dependencies DefinitionCitations, references and other related documents. Each related artifact is either an attachment, or a reference to another knowledge resource, but not both. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| keyword | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.keywordShort description Used to search for the study DefinitionKey terms to aid in searching for or filtering the study. 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. Words associated with the study that may be useful in discovery ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| jurisdiction | Σ | 0..0 | CodeableConceptBinding | There are no (further) constraints on this element Element idResearchStudy.jurisdictionShort description Geographic region(s) for study DefinitionIndicates a country, state or other region where the study is taking place. 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. Countries and regions within which this artifact is targeted for use Jurisdiction ValueSet (extensible) ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| description | 0..1 | markdown | There are no (further) constraints on this element Element idResearchStudy.descriptionShort description What this is study doing DefinitionA full description of how the study is being conducted. Systems are not required to have markdown support, and there is considerable variation in markdown syntax, so the text should be readable without markdown processing. The preferred markdown syntax is described here: http://daringfireball.net/projects/markdown/syntax (and tests here: http://daringfireball.net/projects/downloads/MarkdownTest_1.0.zip) The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| enrollment | Σ C | 0..0 | Reference(Group) | There are no (further) constraints on this element Element idResearchStudy.enrollmentShort description Inclusion & exclusion criteria Alternate namespatient DefinitionReference 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". The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| period | Σ C | 0..1 | Period | There are no (further) constraints on this element Element idResearchStudy.periodShort description When the study began and ended Alternate namestiming DefinitionIdentifies the start date and the expected (or actual, depending on status) end date for the study. [The list of types may be constrained as appropriate for the type of event]. This is not a duration - that's a measure of time (a separate type), but a duration that occurs at a fixed value of time. A Period specifies a range of time; the context of use will specify whether the entire range applies (e.g. "the patient was an inpatient of the hospital for this time range") or one value from the range applies (e.g. "give to the patient between these two times"). If duration is required, specify the type as Interval|Duration. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| sponsor | Σ C | 0..1 | Reference(Organization) | There are no (further) constraints on this element Element idResearchStudy.sponsorShort description Organization responsible for the study DefinitionThe organization responsible for the execution of the study. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| id | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.sponsor.idShort description xml:id (or equivalent in JSON) Definitionunique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Note that FHIR strings may not exceed 1MB in size The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| extension | C | 0..* | Extension | There are no (further) constraints on this element Element idResearchStudy.sponsor.extensionShort description Additional Content defined by implementations Alternate namesextensions, user content DefinitionMay be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. 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. Unordered, Open, by url(Value) Extensions are always sliced by (at least) url ConditionsThe cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| reference | Σ C | 0..0 | string | There are no (further) constraints on this element Element idResearchStudy.sponsor.referenceShort description Literal reference, Relative, internal or absolute URL DefinitionA 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. 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. The cardinality or value of this element may be affected by these constraints: ele-1, ref-1 Constraints
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| identifier | Σ | 0..0 | Identifier | There are no (further) constraints on this element Element idResearchStudy.sponsor.identifierShort description Logical reference, when literal reference is not known DefinitionAn identifier for the other resource. This is used when there is no way to reference the other resource directly, either because the entity 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. 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. When 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 Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| display | Σ | 0..1 | string | There are no (further) constraints on this element Element idResearchStudy.sponsor.displayShort description Text alternative for the resource DefinitionPlain text narrative that identifies the resource in addition to the resource reference. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| principalInvestigator | Σ C | 0..0 | Reference(Practitioner) | There are no (further) constraints on this element Element idResearchStudy.principalInvestigatorShort description The individual responsible for the study DefinitionIndicates the individual who has primary oversite of the execution of the study. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| site | Σ C | 0..0 | Reference(Location) | There are no (further) constraints on this element Element idResearchStudy.siteShort description Location involved in study execution DefinitionClinic, hospital or other healthcare location that is participating in the study. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| reasonStopped | Σ | 0..0 | CodeableConcept | There are no (further) constraints on this element Element idResearchStudy.reasonStoppedShort description Reason for terminating study early DefinitionA description and/or code explaining the premature termination of the study. 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| note | 0..* | Annotation | There are no (further) constraints on this element Element idResearchStudy.noteShort description Comments made about the event DefinitionComments made about the event by the performer, subject or other participants. 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). The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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| arm | 0..0 | BackboneElement | There are no (further) constraints on this element Element idResearchStudy.armShort description Defined path through the study for a subject DefinitionDescribes 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. The cardinality or value of this element may be affected by these constraints: ele-1 Constraints
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