Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème
0.3.0 - trial-use France flag

Essais CLiniques Accessibles Interconnectés pour la Recherche ouverts à l'Ecosystème - Local Development build (v0.3.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: ECLAIREResearchStudy - Detailed Descriptions

Draft as of 2024-02-26

Definitions for the eclaire-researchstudy resource profile.

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
2. ResearchStudy.extension:eclaire-review-date
Slice Nameeclaire-review-date
ShortDate de dernière modification substancielle
Control0..1
TypeExtension(ECLAIREReviewDate) (Extension Type: instant)
Must Supporttrue
4. ResearchStudy.extension:eclaire-approval-date
Slice Nameeclaire-approval-date
ShortDate d'approbation du comité éthique
Control0..1
TypeExtension(ECLAIREApprovalDate) (Extension Type: instant)
Must Supporttrue
6. ResearchStudy.extension:eclaire-therapeutic-area
Slice Nameeclaire-therapeutic-area
ShortDomaine thérapeutique concerné
Control0..1
TypeExtension(ECLAIRETherapeuticArea) (Extension Type: string)
Must Supporttrue
8. ResearchStudy.extension:eclaire-recruitment-period
Slice Nameeclaire-recruitment-period
ShortPériode prévisionnelle de recrutement
Control0..1
TypeExtension(ECLAIRERecruitmentPeriod) (Extension Type: Period)
Must Supporttrue
10. ResearchStudy.extension:eclaire-recruitment-status
Slice Nameeclaire-recruitment-status
ShortStatut du recrutement / Recruitment status
Control0..1
TypeExtension(ECLAIRERecruitmentStatus) (Extension Type: CodeableConcept)
Must Supporttrue
12. ResearchStudy.extension:eclaire-description-summary-r5
Slice Nameeclaire-description-summary-r5
Definition

Cette extension implemente l'élément descriptionSummary de R5. elle permet l'ajout d'un texte bref décrivant l'essai

ShortTexte bref décrivant l'essai / Brief text explaining the study.
Control0..1
TypeExtension(Extension Definition for ResearchStudy.descriptionSummary for Version 5.0) (Extension Type: markdown)
Must Supporttrue
14. ResearchStudy.extension:eclaire-description-summary-r5.value[x]
Control1..?
[x] NoteSee Choice of Data Types for further information about how to use [x]
16. ResearchStudy.extension:eclaire-outcome-measure-r5
Slice Nameeclaire-outcome-measure-r5
Definition

Cette extension implemente l'élément outcomeMeasure de R5. elle permet l'ajout des conséquences principales et secondaires de l'essai

ShortConséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
Control0..*
TypeExtension(ECLAIREoutcomeMeasureR5) (Complex Extension)
Must Supporttrue
18. ResearchStudy.extension:eclaire-associated-party-r5
Slice Nameeclaire-associated-party-r5
Definition

Cette extension implemente l'élément associatedParty de R5 http://hl7.org/fhir/R5/researchstudy-definitions.html#ResearchStudy.associatedParty. elle permet l'ajout des sponsors, collaborateurs et autres parties

ShortSponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
Control0..*
TypeExtension(ECLAIREassociatedPartyR5) (Complex Extension)
Must Supporttrue
20. ResearchStudy.extension:eclaire-label-r5
Slice Nameeclaire-label-r5
Definition

Cette extension implemente l'élément label de R5. elle permet l'ajout de plusieurs titres pour l'essai

ShortAutres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5
Control0..*
TypeExtension(ECLAIRELabelR5) (Complex Extension)
Must Supporttrue
22. ResearchStudy.identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ use
24. ResearchStudy.identifier:idPrimary
Slice NameidPrimary
ShortIdentifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
Must Supporttrue
26. ResearchStudy.identifier:idPrimary.use
Control1..?
Pattern Valueofficial
28. ResearchStudy.identifier:idPrimary.period
30. ResearchStudy.identifier:idPrimary.period.start
ShortDate d'inscription au registre principal / Date of Registration in Primary Registry
32. ResearchStudy.identifier:idSecondary
Slice NameidSecondary
Shortidentifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
Must Supporttrue
34. ResearchStudy.identifier:idSecondary.use
Control1..?
Pattern Valuesecondary
36. ResearchStudy.title
ShortNom scientifique de l'étude / Scientific Title
Must Supporttrue
38. ResearchStudy.status
ShortStatut de l'essai / Study Status
Must Supporttrue
40. ResearchStudy.primaryPurposeType
ShortObjectif principal / Primary purpose
Must Supporttrue
42. ResearchStudy.phase
ShortPhase de l'essai / Study type : phase
BindingUnless not suitable, these codes SHALL be taken from Value Set type de phase de l'essai clinique
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs
Must Supporttrue
44. ResearchStudy.category
ShortType d'essai / Study type : type of study
BindingUnless not suitable, these codes SHALL be taken from Value Set type pour spécifier la catégorie l'essai clinique
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs
Must Supporttrue
46. ResearchStudy.condition
ShortSujet concerné / Problem(s) Studied exemple code MedDRA
Must Supporttrue
SlicingThis element introduces a set of slices on ResearchStudy.condition. The slices are unordered and Open, and defines no discriminators to differentiate the slices
48. ResearchStudy.condition:medDRACondition
Slice NamemedDRACondition
Shortcode MedDRA / MedDRA condition
Control0..*
Must Supporttrue
50. ResearchStudy.condition:medDRACondition.id
Pattern Valuemeddra-condition
52. ResearchStudy.condition:medDRACondition.coding
54. ResearchStudy.condition:medDRACondition.coding.system
Pattern Valuehttp://terminology.hl7.org/CodeSystem/mdr
56. ResearchStudy.condition:diseaseCondition
Slice NamediseaseCondition
Shortcondition de la pathologie / Disease Condition
Control0..*
Must Supporttrue
58. ResearchStudy.condition:diseaseCondition.id
Pattern Valuedisease-condition
60. ResearchStudy.condition:diseaseCondition.text
Control1..?
62. ResearchStudy.contact
ShortContact (Contact for public / scientific queries)
Must Supporttrue
64. ResearchStudy.contact.extension:eclaire-contact-type
Slice Nameeclaire-contact-type
ShortType de contact : Public ou Scientific
Control0..1
TypeExtension(ECLAIREContactType) (Extension Type: CodeableConcept)
Must Supporttrue
66. ResearchStudy.contact.extension:eclaire-contact-address
Slice Nameeclaire-contact-address
ShortAdresse du contact
Control0..1
TypeExtension(ECLAIREContactAddress) (Extension Type: Address)
Must Supporttrue
68. ResearchStudy.contact.extension:eclaire-contact-affiliation
Slice Nameeclaire-contact-affiliation
ShortAffiliation du contact
Control0..1
TypeExtension(ECLAIREContactAffiliation) (Extension Type: string)
Must Supporttrue
70. ResearchStudy.contact.extension:eclaire-contact-name
Slice Nameeclaire-contact-name
ShortNom du contact
Control0..1
TypeExtension(ECLAIREContactName) (Extension Type: HumanName)
Must Supporttrue
72. ResearchStudy.relatedArtifact
ShortPublications et résumé des résultats / Publications about the study and Summary results
Must Supporttrue
74. ResearchStudy.location
ShortPays de recrutement / Countries of Recruitment
Must Supporttrue
76. ResearchStudy.description
ShortRésumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results
Must Supporttrue
78. ResearchStudy.enrollment
ShortCritères d'inclusion et d'exclusion / Inclusion & exclusion criteria
TypeReference(ECLAIREGroup)
Must Supporttrue
80. ResearchStudy.period
82. ResearchStudy.period.end
ShortDate à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date
Must Supporttrue
84. ResearchStudy.sponsor
Control0..0
86. ResearchStudy.principalInvestigator
Control0..0
88. ResearchStudy.site
ShortLieux / Countries of Recruitment
TypeReference(ECLAIRELocation)
Must Supporttrue
90. ResearchStudy.arm
92. ResearchStudy.arm.extension:eclaire-arm-intervention
Slice Nameeclaire-arm-intervention
ShortIntervention / For each arm of the trial record a brief intervention name plus an intervention description.
Control0..*
TypeExtension(ECLAIREArmIntervention) (Complex Extension)
Must Supporttrue

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
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.

ShortInvestigation to increase healthcare-related patient-independent knowledge
Comments

Need to make sure we encompass public health studies.

Control0..*
Alternate NamesClinical Trial, Study
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: 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 (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())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
2. ResearchStudy.implicitRules
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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. ResearchStudy.extension:eclaire-review-date
Slice Nameeclaire-review-date
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout d'une date de révision fonctionnelle lorque que l'on souhaite indiquer la date de la dernière modification substancielle

ShortDate de dernière modification substancielle
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREReviewDate) (Extension Type: instant)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
6. ResearchStudy.extension:eclaire-approval-date
Slice Nameeclaire-approval-date
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout la date d'approbation du comité éthique

ShortDate d'approbation du comité éthique
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREApprovalDate) (Extension Type: instant)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. ResearchStudy.extension:eclaire-therapeutic-area
Slice Nameeclaire-therapeutic-area
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout du domaine thérapeutique concerné par l'essai

ShortDomaine thérapeutique concerné
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRETherapeuticArea) (Extension Type: string)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
10. ResearchStudy.extension:eclaire-recruitment-period
Slice Nameeclaire-recruitment-period
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de la période prévisionnelle de recrutement l'essai

ShortPériode prévisionnelle de recrutement
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRERecruitmentPeriod) (Extension Type: Period)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. ResearchStudy.extension:eclaire-recruitment-status
Slice Nameeclaire-recruitment-status
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer le statut du recrutement

ShortStatut du recrutement / Recruitment status
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRERecruitmentStatus) (Extension Type: CodeableConcept)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
14. ResearchStudy.extension:eclaire-description-summary-r5
Slice Nameeclaire-description-summary-r5
Definition

Cette extension implemente l'élément descriptionSummary de R5. elle permet l'ajout d'un texte bref décrivant l'essai

ShortTexte bref décrivant l'essai / Brief text explaining the study.
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(Extension Definition for ResearchStudy.descriptionSummary for Version 5.0) (Extension Type: markdown)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
16. ResearchStudy.extension:eclaire-description-summary-r5.extension
Definition

An Extension


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.

ShortExtensionAdditional content defined by implementations
Comments

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.

Control0..0*
This element is affected by the following invariants: ele-1
TypeExtension
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
18. ResearchStudy.extension:eclaire-description-summary-r5.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
XML FormatIn the XML format, this property is represented as an attribute.
Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
20. ResearchStudy.extension:eclaire-description-summary-r5.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

ShortValue of extension
Control10..1
This element is affected by the following invariants: ele-1
Typemarkdown, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. ResearchStudy.extension:eclaire-outcome-measure-r5
Slice Nameeclaire-outcome-measure-r5
Definition

Cette extension implemente l'élément outcomeMeasure de R5. elle permet l'ajout des conséquences principales et secondaires de l'essai

ShortConséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREoutcomeMeasureR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
24. ResearchStudy.extension:eclaire-associated-party-r5
Slice Nameeclaire-associated-party-r5
Definition

Cette extension implemente l'élément associatedParty de R5 http://hl7.org/fhir/R5/researchstudy-definitions.html#ResearchStudy.associatedParty. elle permet l'ajout des sponsors, collaborateurs et autres parties

ShortSponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREassociatedPartyR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
26. ResearchStudy.extension:eclaire-label-r5
Slice Nameeclaire-label-r5
Definition

Cette extension implemente l'élément label de R5. elle permet l'ajout de plusieurs titres pour l'essai

ShortAutres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRELabelR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
28. ResearchStudy.modifierExtension
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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Standards StatusNormative (from Trial Use)
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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
30. ResearchStudy.identifier
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
This element is affected by the following invariants: ele-1
TypeIdentifier
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ use
32. ResearchStudy.identifier:idPrimary
Slice NameidPrimary
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortIdentifiant primaire de l'essai clinique / Primary Registry and Trial Identifying NumberBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1*
This element is affected by the following invariants: ele-1
TypeIdentifier
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. ResearchStudy.identifier:idPrimary.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control10..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Pattern Valueofficial
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ResearchStudy.identifier:idSecondary
Slice NameidSecondary
Definition

Identifiers assigned to this research study by the sponsor or other systems.

Shortidentifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.Business Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
This element is affected by the following invariants: ele-1
TypeIdentifier
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. ResearchStudy.identifier:idSecondary.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control10..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|4.0.1
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Pattern Valuesecondary
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
40. ResearchStudy.title
Definition

A short, descriptive user-friendly label for the study.

ShortNom scientifique de l'étude / Scientific TitleName for this study
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. ResearchStudy.status
Definition

The current state of the study.

ShortStatut de l'essai / Study Statusactive | 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
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from ResearchStudyStatushttp://hl7.org/fhir/ValueSet/research-study-status|4.0.1
(required to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. ResearchStudy.primaryPurposeType
Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

ShortObjectif principal / Primary purposetreatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeTypehttp://hl7.org/fhir/ValueSet/research-study-prim-purp-type
(extensible to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
46. ResearchStudy.phase
Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

ShortPhase de l'essai / Study type : phasen-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see Value Set type de phase de l'essai cliniquehttp://hl7.org/fhir/ValueSet/research-study-phase
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ResearchStudy.category
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortType d'essai / Study type : type of studyClassifications for the study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from For example codes, see Value Set type pour spécifier la catégorie l'essai clinique
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. ResearchStudy.condition
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.

ShortSujet concerné / Problem(s) Studied exemple code MedDRACondition being studied
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.condition. The slices are unordered and Open, and defines no discriminators to differentiate the slices
52. ResearchStudy.condition:medDRACondition
Slice NamemedDRACondition
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.

Shortcode MedDRA / MedDRA conditionCondition being studied
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ResearchStudy.condition:medDRACondition.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
Pattern Valuemeddra-condition
56. ResearchStudy.condition:diseaseCondition
Slice NamediseaseCondition
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.

Shortcondition de la pathologie / Disease ConditionCondition being studied
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodeshttp://hl7.org/fhir/ValueSet/condition-code
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ResearchStudy.condition:diseaseCondition.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
Pattern Valuedisease-condition
60. ResearchStudy.condition:diseaseCondition.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control10..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
62. ResearchStudy.contact
Definition

Contact details to assist a user in learning more about or engaging with the study.

ShortContact (Contact for public / scientific queries)Contact details for the study
Control0..*
This element is affected by the following invariants: ele-1
TypeContactDetail
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
64. ResearchStudy.contact.extension:eclaire-contact-type
Slice Nameeclaire-contact-type
Definition

Extension créée dans le cadre du projet ECLAIRE qui indique le type de Contact : Public ou Scientific

ShortType de contact : Public ou Scientific
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactType) (Extension Type: CodeableConcept)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
66. ResearchStudy.contact.extension:eclaire-contact-address
Slice Nameeclaire-contact-address
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer l'adresse du contact

ShortAdresse du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactAddress) (Extension Type: Address)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
68. ResearchStudy.contact.extension:eclaire-contact-affiliation
Slice Nameeclaire-contact-affiliation
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer l'affiliation du contact

ShortAffiliation du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactAffiliation) (Extension Type: string)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
70. ResearchStudy.contact.extension:eclaire-contact-name
Slice Nameeclaire-contact-name
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer le nom de contact

ShortNom du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactName) (Extension Type: HumanName)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
72. ResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

ShortPublications et résumé des résultats / Publications about the study and Summary resultsReferences and dependencies
Comments

Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

Control0..*
This element is affected by the following invariants: ele-1
TypeRelatedArtifact
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ResearchStudy.location
Definition

Indicates a country, state or other region where the study is taking place.

ShortPays de recrutement / Countries of RecruitmentGeographic region(s) for study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSethttp://hl7.org/fhir/ValueSet/jurisdiction
(extensible to http://hl7.org/fhir/ValueSet/jurisdiction
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
76. ResearchStudy.description
Definition

A full description of how the study is being conducted.

ShortRésumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary ResultsWhat this is study doing
Comments

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/

Control0..1
This element is affected by the following invariants: ele-1
Typemarkdown
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
78. ResearchStudy.enrollment
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".

ShortCritères d'inclusion et d'exclusion / Inclusion & exclusion criteriaInclusion & exclusion criteria
Comments

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(ECLAIREGroup, Group)
Must Supporttrue
Summarytrue
Alternate Namespatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
80. ResearchStudy.period
Definition

Identifies the start date and the expected (or actual, depending on status) end date for the study.

ShortWhen the study began and ended
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Control0..1
This element is affected by the following invariants: ele-1
TypePeriod
Summarytrue
Alternate Namestiming
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
82. ResearchStudy.period.start
Definition

The start of the period. The boundary is inclusive.

ShortStarting time with inclusive boundary
Comments

If the low element is missing, the meaning is that the low boundary is not known.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ResearchStudy.period.end
Definition

The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

ShortDate à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion dateEnd time with inclusive boundary, if not ongoing
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ResearchStudy.sponsor
Definition

An organization that initiates the investigation and is legally responsible for the study.

ShortOrganization that initiates and is legally responsible for the study
Comments

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.

Control0..01
This element is affected by the following invariants: ele-1
TypeReference(Organization)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
88. ResearchStudy.principalInvestigator
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.

ShortResearcher who oversees multiple aspects of the study
Comments

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.

Control0..01
This element is affected by the following invariants: ele-1
TypeReference(Practitioner, PractitionerRole)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
90. ResearchStudy.site
Definition

A facility in which study activities are conducted.

ShortLieux / Countries of RecruitmentFacility where study activities are conducted
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(ECLAIRELocation, Location)
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
92. ResearchStudy.arm
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.

ShortDefined path through the study for a subject
Control0..*
This element is affected by the following invariants: ele-1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
94. ResearchStudy.arm.extension:eclaire-arm-intervention
Slice Nameeclaire-arm-intervention
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer les 'Interventions' dans les cohortes

ShortIntervention / For each arm of the trial record a brief intervention name plus an intervention description.
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREArmIntervention) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
96. ResearchStudy.arm.modifierExtension
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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
98. ResearchStudy.arm.name
Definition

Unique, human-readable label for this arm of the study.

ShortLabel for study arm
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control1..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

Guidance on how to interpret the contents of this table can be found here

0. ResearchStudy
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.

ShortInvestigation to increase healthcare-related patient-independent knowledge
Comments

Need to make sure we encompass public health studies.

Control0..*
Alternate NamesClinical Trial, Study
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-3: 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 (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())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
2. ResearchStudy.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

ShortLogical id of this artifact
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

Control0..1
Typeid
Summarytrue
4. ResearchStudy.meta
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.

ShortMetadata about the resource
Control0..1
This element is affected by the following invariants: ele-1
TypeMeta
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. ResearchStudy.implicitRules
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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. ResearchStudy.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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).

Control0..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from CommonLanguages
(preferred to http://hl7.org/fhir/ValueSet/languages
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
10. ResearchStudy.text
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.

ShortText summary of the resource, for human interpretation
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
12. ResearchStudy.contained
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.

ShortContained, inline Resources
Comments

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.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
14. ResearchStudy.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
16. ResearchStudy.extension:eclaire-review-date
Slice Nameeclaire-review-date
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout d'une date de révision fonctionnelle lorque que l'on souhaite indiquer la date de la dernière modification substancielle

ShortDate de dernière modification substancielle
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREReviewDate) (Extension Type: instant)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
18. ResearchStudy.extension:eclaire-approval-date
Slice Nameeclaire-approval-date
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout la date d'approbation du comité éthique

ShortDate d'approbation du comité éthique
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREApprovalDate) (Extension Type: instant)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
20. ResearchStudy.extension:eclaire-therapeutic-area
Slice Nameeclaire-therapeutic-area
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout du domaine thérapeutique concerné par l'essai

ShortDomaine thérapeutique concerné
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRETherapeuticArea) (Extension Type: string)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
22. ResearchStudy.extension:eclaire-recruitment-period
Slice Nameeclaire-recruitment-period
Definition

Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de la période prévisionnelle de recrutement l'essai

ShortPériode prévisionnelle de recrutement
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRERecruitmentPeriod) (Extension Type: Period)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
24. ResearchStudy.extension:eclaire-recruitment-status
Slice Nameeclaire-recruitment-status
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer le statut du recrutement

ShortStatut du recrutement / Recruitment status
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRERecruitmentStatus) (Extension Type: CodeableConcept)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
26. ResearchStudy.extension:eclaire-description-summary-r5
Slice Nameeclaire-description-summary-r5
Definition

Cette extension implemente l'élément descriptionSummary de R5. elle permet l'ajout d'un texte bref décrivant l'essai

ShortTexte bref décrivant l'essai / Brief text explaining the study.
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(Extension Definition for ResearchStudy.descriptionSummary for Version 5.0) (Extension Type: markdown)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
28. ResearchStudy.extension:eclaire-description-summary-r5.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
30. ResearchStudy.extension:eclaire-description-summary-r5.extension
Definition

An Extension

ShortExtension
Control0..0
This element is affected by the following invariants: ele-1
TypeExtension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.extension.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
32. ResearchStudy.extension:eclaire-description-summary-r5.url
Definition

Source of the definition for the extension code - a logical name or a URL.

Shortidentifies the meaning of the extension
Comments

The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

Control1..1
Typeuri
XML FormatIn the XML format, this property is represented as an attribute.
Fixed Valuehttp://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary
34. ResearchStudy.extension:eclaire-description-summary-r5.value[x]
Definition

Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

ShortValue of extension
Control1..1
This element is affected by the following invariants: ele-1
Typemarkdown
[x] NoteSee Choice of Data Types for further information about how to use [x]
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. ResearchStudy.extension:eclaire-outcome-measure-r5
Slice Nameeclaire-outcome-measure-r5
Definition

Cette extension implemente l'élément outcomeMeasure de R5. elle permet l'ajout des conséquences principales et secondaires de l'essai

ShortConséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREoutcomeMeasureR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
38. ResearchStudy.extension:eclaire-associated-party-r5
Slice Nameeclaire-associated-party-r5
Definition

Cette extension implemente l'élément associatedParty de R5 http://hl7.org/fhir/R5/researchstudy-definitions.html#ResearchStudy.associatedParty. elle permet l'ajout des sponsors, collaborateurs et autres parties

ShortSponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREassociatedPartyR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
40. ResearchStudy.extension:eclaire-label-r5
Slice Nameeclaire-label-r5
Definition

Cette extension implemente l'élément label de R5. elle permet l'ajout de plusieurs titres pour l'essai

ShortAutres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIRELabelR5) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
42. ResearchStudy.modifierExtension
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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Standards StatusNormative (from Trial Use)
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.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.modifierExtension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
44. ResearchStudy.identifier
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortBusiness Identifier for study
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
This element is affected by the following invariants: ele-1
TypeIdentifier
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.identifier. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ use
46. ResearchStudy.identifier:idPrimary
Slice NameidPrimary
Definition

Identifiers assigned to this research study by the sponsor or other systems.

ShortIdentifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..1
This element is affected by the following invariants: ele-1
TypeIdentifier
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. ResearchStudy.identifier:idPrimary.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
50. ResearchStudy.identifier:idPrimary.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
52. ResearchStudy.identifier:idPrimary.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Pattern Valueofficial
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
54. ResearchStudy.identifier:idPrimary.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type
TypeCodeableConcept
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
56. ResearchStudy.identifier:idPrimary.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
58. ResearchStudy.identifier:idPrimary.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
60. ResearchStudy.identifier:idPrimary.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Control0..1
This element is affected by the following invariants: ele-1
TypePeriod
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
62. ResearchStudy.identifier:idPrimary.period.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
64. ResearchStudy.identifier:idPrimary.period.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.period.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
66. ResearchStudy.identifier:idPrimary.period.start
Definition

The start of the period. The boundary is inclusive.

ShortDate d'inscription au registre principal / Date of Registration in Primary Registry
Comments

If the low element is missing, the meaning is that the low boundary is not known.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
68. ResearchStudy.identifier:idPrimary.period.end
Definition

The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

ShortEnd time with inclusive boundary, if not ongoing
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
70. ResearchStudy.identifier:idPrimary.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
TypeReference(Organization)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
72. ResearchStudy.identifier:idSecondary
Slice NameidSecondary
Definition

Identifiers assigned to this research study by the sponsor or other systems.

Shortidentifiants secondaires / Secondary Identifying Numbers (e.g., protocol number) if available. Also include other trial registries that have issued an identifying number to this trial. There is no limit on the number of Secondary identifying numbers that can be provided.
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..*
This element is affected by the following invariants: ele-1
TypeIdentifier
Must Supporttrue
Summarytrue
Requirements

Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
74. ResearchStudy.identifier:idSecondary.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
76. ResearchStudy.identifier:idSecondary.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.identifier.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
78. ResearchStudy.identifier:idSecondary.use
Definition

The purpose of this identifier.

Shortusual | official | temp | secondary | old (If known)
Comments

Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from IdentifierUse
(required to http://hl7.org/fhir/ValueSet/identifier-use|4.0.1
Typecode
Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

Pattern Valuesecondary
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
80. ResearchStudy.identifier:idSecondary.type
Definition

A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

ShortDescription of identifier
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Identifier Type Codes
(extensible to http://hl7.org/fhir/ValueSet/identifier-type
TypeCodeableConcept
Summarytrue
Requirements

Allows users to make use of identifiers when the identifier system is not known.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
82. ResearchStudy.identifier:idSecondary.system
Definition

Establishes the namespace for the value - that is, a URL that describes a set values that are unique.

ShortThe namespace for the identifier value
Comments

Identifier.system is always case sensitive.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
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.

Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
84. ResearchStudy.identifier:idSecondary.value
Definition

The portion of the identifier typically relevant to the user and which is unique within the context of the system.

ShortThe value that is unique
Comments

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. 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.

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Example<br/><b>General</b>:123456
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
86. ResearchStudy.identifier:idSecondary.period
Definition

Time period during which identifier is/was valid for use.

ShortTime period when id is/was valid for use
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Control0..1
This element is affected by the following invariants: ele-1
TypePeriod
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
88. ResearchStudy.identifier:idSecondary.assigner
Definition

Organization that issued/manages the identifier.

ShortOrganization that issued id (may be just text)
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
TypeReference(Organization)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
90. ResearchStudy.title
Definition

A short, descriptive user-friendly label for the study.

ShortNom scientifique de l'étude / Scientific Title
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
92. ResearchStudy.protocol
Definition

The set of steps expected to be performed as part of the execution of the study.

ShortSteps followed in executing study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(PlanDefinition)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
94. ResearchStudy.partOf
Definition

A larger research study of which this particular study is a component or step.

ShortPart of larger study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(ResearchStudy)
Summarytrue
Requirements

Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.

Alternate Namescontainer
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
96. ResearchStudy.status
Definition

The current state of the study.

ShortStatut de l'essai / Study Status
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control1..1
This element is affected by the following invariants: ele-1
BindingThe codes SHALL be taken from ResearchStudyStatus
(required to http://hl7.org/fhir/ValueSet/research-study-status|4.0.1
Typecode
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
98. ResearchStudy.primaryPurposeType
Definition

The type of study based upon the intent of the study's activities. A classification of the intent of the study.

ShortObjectif principal / Primary purpose
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from ResearchStudyPrimaryPurposeType
(extensible to http://hl7.org/fhir/ValueSet/research-study-prim-purp-type
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
100. ResearchStudy.phase
Definition

The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.

ShortPhase de l'essai / Study type : phase
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Value Set type de phase de l'essai clinique
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-study-phase-vs
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
102. ResearchStudy.category
Definition

Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.

ShortType d'essai / Study type : type of study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Value Set type pour spécifier la catégorie l'essai clinique
(extensible to https://interop.esante.gouv.fr/ig/fhir/eclaire/ValueSet/eclaire-category-vs
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
104. ResearchStudy.focus
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.

ShortDrugs, devices, etc. under study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
Binding

Codes for medications, devices and other interventions.

TypeCodeableConcept
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
106. ResearchStudy.condition
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.

ShortSujet concerné / Problem(s) Studied exemple code MedDRA
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodes
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on ResearchStudy.condition. The slices are unordered and Open, and defines no discriminators to differentiate the slices
108. ResearchStudy.condition:medDRACondition
Slice NamemedDRACondition
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.

Shortcode MedDRA / MedDRA condition
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodes
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
110. ResearchStudy.condition:medDRACondition.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
Pattern Valuemeddra-condition
112. ResearchStudy.condition:medDRACondition.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.condition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
114. ResearchStudy.condition:medDRACondition.coding
Definition

A reference to a code defined by a terminology system.

ShortCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
This element is affected by the following invariants: ele-1
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
116. ResearchStudy.condition:medDRACondition.coding.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
118. ResearchStudy.condition:medDRACondition.coding.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.condition.coding.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
120. ResearchStudy.condition:medDRACondition.coding.system
Definition

The identification of the code system that defines the meaning of the symbol in the code.

ShortIdentity of the terminology system
Comments

The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.

Control0..1
This element is affected by the following invariants: ele-1
Typeuri
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be unambiguous about the source of the definition of the symbol.

Pattern Valuehttp://terminology.hl7.org/CodeSystem/mdr
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
122. ResearchStudy.condition:medDRACondition.coding.version
Definition

The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

ShortVersion of the system - if relevant
Comments

Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

NoteThis is a business versionId, not a resource version id (see discussion)
Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
124. ResearchStudy.condition:medDRACondition.coding.code
Definition

A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

ShortSymbol in syntax defined by the system
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typecode
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to refer to a particular code in the system.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
126. ResearchStudy.condition:medDRACondition.coding.display
Definition

A representation of the meaning of the code in the system, following the rules of the system.

ShortRepresentation defined by the system
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
128. ResearchStudy.condition:medDRACondition.coding.userSelected
Definition

Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

ShortIf this coding was chosen directly by the user
Comments

Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

Control0..1
This element is affected by the following invariants: ele-1
Typeboolean
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
130. ResearchStudy.condition:medDRACondition.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
132. ResearchStudy.condition:diseaseCondition
Slice NamediseaseCondition
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.

Shortcondition de la pathologie / Disease Condition
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingFor example codes, see Condition/Problem/DiagnosisCodes
(example to http://hl7.org/fhir/ValueSet/condition-code
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
134. ResearchStudy.condition:diseaseCondition.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
Pattern Valuedisease-condition
136. ResearchStudy.condition:diseaseCondition.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.condition.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
138. ResearchStudy.condition:diseaseCondition.coding
Definition

A reference to a code defined by a terminology system.

ShortCode defined by a terminology system
Comments

Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

Control0..*
This element is affected by the following invariants: ele-1
TypeCoding
Summarytrue
Requirements

Allows for alternative encodings within a code system, and translations to other code systems.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
140. ResearchStudy.condition:diseaseCondition.text
Definition

A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

ShortPlain text representation of the concept
Comments

Very often the text is the same as a displayName of one of the codings.

Control1..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Requirements

The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
142. ResearchStudy.contact
Definition

Contact details to assist a user in learning more about or engaging with the study.

ShortContact (Contact for public / scientific queries)
Control0..*
This element is affected by the following invariants: ele-1
TypeContactDetail
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
144. ResearchStudy.contact.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
146. ResearchStudy.contact.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.contact.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
148. ResearchStudy.contact.extension:eclaire-contact-type
Slice Nameeclaire-contact-type
Definition

Extension créée dans le cadre du projet ECLAIRE qui indique le type de Contact : Public ou Scientific

ShortType de contact : Public ou Scientific
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactType) (Extension Type: CodeableConcept)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
150. ResearchStudy.contact.extension:eclaire-contact-address
Slice Nameeclaire-contact-address
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer l'adresse du contact

ShortAdresse du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactAddress) (Extension Type: Address)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
152. ResearchStudy.contact.extension:eclaire-contact-affiliation
Slice Nameeclaire-contact-affiliation
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer l'affiliation du contact

ShortAffiliation du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactAffiliation) (Extension Type: string)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
154. ResearchStudy.contact.extension:eclaire-contact-name
Slice Nameeclaire-contact-name
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer le nom de contact

ShortNom du contact
Control0..1
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREContactName) (Extension Type: HumanName)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
156. ResearchStudy.contact.name
Definition

The name of an individual to contact.

ShortName of an individual to contact
Comments

If there is no named individual, the telecom information is for the organization as a whole.

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
158. ResearchStudy.contact.telecom
Definition

The contact details for the individual (if a name was provided) or the organization.

ShortContact details for individual or organization
Control0..*
This element is affected by the following invariants: ele-1
TypeContactPoint
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
cpt-2: A system is required if a value is provided. (value.empty() or system.exists())
160. ResearchStudy.relatedArtifact
Definition

Citations, references and other related documents.

ShortPublications et résumé des résultats / Publications about the study and Summary results
Comments

Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.

Control0..*
This element is affected by the following invariants: ele-1
TypeRelatedArtifact
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
162. ResearchStudy.keyword
Definition

Key terms to aid in searching for or filtering the study.

ShortUsed to search for the study
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
Binding

Words associated with the study that may be useful in discovery.

TypeCodeableConcept
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
164. ResearchStudy.location
Definition

Indicates a country, state or other region where the study is taking place.

ShortPays de recrutement / Countries of Recruitment
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
BindingUnless not suitable, these codes SHALL be taken from Jurisdiction ValueSet
(extensible to http://hl7.org/fhir/ValueSet/jurisdiction
TypeCodeableConcept
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
166. ResearchStudy.description
Definition

A full description of how the study is being conducted.

ShortRésumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results
Comments

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/

Control0..1
This element is affected by the following invariants: ele-1
Typemarkdown
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
168. ResearchStudy.enrollment
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".

ShortCritères d'inclusion et d'exclusion / Inclusion & exclusion criteria
Comments

The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(ECLAIREGroup)
Must Supporttrue
Summarytrue
Alternate Namespatient
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
170. ResearchStudy.period
Definition

Identifies the start date and the expected (or actual, depending on status) end date for the study.

ShortWhen the study began and ended
Comments

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").

Period is not used for a duration (a measure of elapsed time). See Duration.

Control0..1
This element is affected by the following invariants: ele-1
TypePeriod
Summarytrue
Alternate Namestiming
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
per-1: If present, start SHALL have a lower value than end (start.hasValue().not() or end.hasValue().not() or (start <= end))
172. ResearchStudy.period.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
174. ResearchStudy.period.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.period.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
176. ResearchStudy.period.start
Definition

The start of the period. The boundary is inclusive.

ShortStarting time with inclusive boundary
Comments

If the low element is missing, the meaning is that the low boundary is not known.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
178. ResearchStudy.period.end
Definition

The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

ShortDate à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date
Comments

The high value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

Control0..1
This element is affected by the following invariants: ele-1, per-1
TypedateTime
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supporttrue
Summarytrue
Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
180. ResearchStudy.sponsor
Definition

An organization that initiates the investigation and is legally responsible for the study.

ShortOrganization that initiates and is legally responsible for the study
Comments

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.

Control0..0
This element is affected by the following invariants: ele-1
TypeReference(Organization)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
182. ResearchStudy.principalInvestigator
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.

ShortResearcher who oversees multiple aspects of the study
Comments

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.

Control0..0
This element is affected by the following invariants: ele-1
TypeReference(Practitioner, PractitionerRole)
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
184. ResearchStudy.site
Definition

A facility in which study activities are conducted.

ShortLieux / Countries of Recruitment
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeReference(ECLAIRELocation)
Must Supporttrue
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ref-1: SHALL have a contained resource if a local reference is provided (reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids')))
186. ResearchStudy.reasonStopped
Definition

A description and/or code explaining the premature termination of the study.

Shortaccrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingFor example codes, see ResearchStudyReasonStopped
(example to http://hl7.org/fhir/ValueSet/research-study-reason-stopped
TypeCodeableConcept
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
188. ResearchStudy.note
Definition

Comments made about the study by the performer, subject or other participants.

ShortComments made about the study
Comments

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).

Control0..*
This element is affected by the following invariants: ele-1
TypeAnnotation
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
190. ResearchStudy.arm
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.

ShortDefined path through the study for a subject
Control0..*
This element is affected by the following invariants: ele-1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
192. ResearchStudy.arm.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
194. ResearchStudy.arm.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.arm.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
196. ResearchStudy.arm.extension:eclaire-arm-intervention
Slice Nameeclaire-arm-intervention
Definition

Extension créée dans le cadre du projet ECLAIRE pour indiquer les 'Interventions' dans les cohortes

ShortIntervention / For each arm of the trial record a brief intervention name plus an intervention description.
Control0..*
This element is affected by the following invariants: ele-1
TypeExtension(ECLAIREArmIntervention) (Complex Extension)
Must Supporttrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
198. ResearchStudy.arm.modifierExtension
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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
200. ResearchStudy.arm.name
Definition

Unique, human-readable label for this arm of the study.

ShortLabel for study arm
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control1..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
202. ResearchStudy.arm.type
Definition

Categorization of study arm, e.g. experimental, active comparator, placebo comparater.

ShortCategorization of study arm
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
TypeCodeableConcept
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
204. ResearchStudy.arm.description
Definition

A succinct description of the path through the study that would be followed by a subject adhering to this arm.

ShortShort explanation of study path
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
206. ResearchStudy.objective
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.

ShortA goal for the study
Control0..*
This element is affected by the following invariants: ele-1
TypeBackboneElement
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
208. ResearchStudy.objective.id
Definition

Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

ShortUnique id for inter-element referencing
Control0..1
Typestring
XML FormatIn the XML format, this property is represented as an attribute.
210. ResearchStudy.objective.extension
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.

ShortAdditional content defined by implementations
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Standards StatusNormative (from Trial Use)
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on ResearchStudy.objective.extension. The slices are unordered and Open, and can be differentiated using the following discriminators:
  • value @ url
212. ResearchStudy.objective.modifierExtension
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.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensions that cannot be ignored even if unrecognized
Comments

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.

Control0..*
This element is affected by the following invariants: ele-1
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summarytrue
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.

Alternate Namesextensions, user content, modifiers
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
214. ResearchStudy.objective.name
Definition

Unique, human-readable label for this objective of the study.

ShortLabel for the objective
Comments

Note that FHIR strings SHALL NOT exceed 1MB in size

Control0..1
This element is affected by the following invariants: ele-1
Typestring
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
216. ResearchStudy.objective.type
Definition

The kind of study objective.

Shortprimary | secondary | exploratory
Comments

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.

Control0..1
This element is affected by the following invariants: ele-1
BindingThe codes SHOULD be taken from ResearchStudyObjectiveType
(preferred to http://hl7.org/fhir/ValueSet/research-study-objective-type
TypeCodeableConcept
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))