Narratif généré : DéfinitionStructure eclaire-researchstudy Nom Drapeaux Card. Type Description et contraintes ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge #xD; Slices pour extension Content/Rules for all slices #xD; extension:eclaire-review-date S 0..1 instant Date de dernière modification substancielle URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-review-date #xD; extension:eclaire-approval-date S 0..1 instant Date d'approbation du comité éthique URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-approval-date #xD; extension:eclaire-therapeutic-area S 0..1 string Domaine thérapeutique concerné URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-therapeutic-area #xD; extension:eclaire-recruitment-period S 0..1 Period Période prévisionnelle de recrutement URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-period #xD; extension:eclaire-recruitment-status S 0..1 CodeableConcept Statut du recrutement / Recruitment status URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-recruitment-status Binding: Statut de recrutement Value Set (extensible) #xD; extension:eclaire-description-summary-r5 S 0..1 markdown Texte bref décrivant l'essai / Brief text explaining the study (Brief summary) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary #xD; extension:eclaire-outcome-measure-r5 S 0..* (Complex) Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes) URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure #xD; extension:eclaire-associated-party-r5 S 0..* (Complex) Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty #xD; extension:eclaire-label-r5 S 0..* (Complex) Autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5 URL: http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label #xD; Slices pour identifier 0..* Identifier Business Identifier for study Slice: Unordered, Open by value:use, value:system #xD; identifier:idPrimary S 0..1 Identifier Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number #xD; use 1..1 code usual | official | temp | secondary | old (If known) Required Pattern: official #xD; period #xD; start 0..1 dateTime Date d'inscription au registre principal / Date of Registration in Primary Registry #xD; identifier:idSecondary S 0..* Identifier identifiants 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. #xD; use 1..1 code usual | official | temp | secondary | old (If known) Required Pattern: secondary #xD; title S 0..1 string Nom scientifique de l'étude / Scientific Title #xD; status S 1..1 code Statut de l'essai / Study Status #xD; primaryPurposeType S 0..1 CodeableConcept Objectif principal / Primary purpose #xD; phase S 0..1 CodeableConcept Phase de l'essai / Study type : phase Binding: Value Set type de phase de l'essai clinique (extensible) #xD; category S 0..* CodeableConcept Type d'essai / Study type : type of study Binding: Value Set type pour spécifier la catégorie l'essai clinique (extensible) #xD; Slices pour condition S 0..* CodeableConcept Sujet concerné / Problem(s) Studied exemple code MedDRA Slice: Unordered, Open by #xD; condition:medDRACondition S 0..* CodeableConcept code MedDRA / MedDRA condition #xD; id 0..1 string Unique id for inter-element referencing Required Pattern: meddra-condition #xD; coding #xD; system 0..1 uri Identity of the terminology system Required Pattern: https://www.meddra.org #xD; condition:diseaseCondition S 0..* CodeableConcept condition de la pathologie / Disease Condition #xD; id 0..1 string Unique id for inter-element referencing Required Pattern: disease-condition #xD; text 1..1 string Plain text representation of the concept #xD; contact S 0..* ContactDetail Contact (Contact for public / scientific queries) #xD; Slices pour extension Content/Rules for all slices #xD; extension:eclaire-contact-type S 0..1 CodeableConcept Type de contact : Public ou Scientific URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-type Binding: Type Contact Value Set (required) #xD; extension:eclaire-contact-address S 0..1 Address Adresse du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-address #xD; extension:eclaire-contact-affiliation S 0..1 string Affiliation du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-affiliation #xD; extension:eclaire-contact-name S 0..1 HumanName Nom du contact URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-contact-name #xD; relatedArtifact S 0..* RelatedArtifact Publications et résumé des résultats / Publications about the study and Summary results #xD; location S 0..* CodeableConcept Pays de recrutement / Countries of Recruitment #xD; description S 0..1 markdown Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results #xD; enrollment S 0..* Reference(ECLAIREGroup) Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria #xD; period #xD; end S 0..1 dateTime Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date #xD; sponsor 0..0 Organization that initiates and is legally responsible for the study #xD; principalInvestigator 0..0 Researcher who oversees multiple aspects of the study #xD; site S 0..* Reference(ECLAIRELocation) Lieux / Countries of Recruitment #xD; arm #xD; Slices pour extension Content/Rules for all slices #xD; extension:eclaire-arm-intervention S 0..* (Complex) Intervention / For each arm of the trial record a brief intervention name plus an intervention description. URL: https://interop.esante.gouv.fr/ig/fhir/eclaire/StructureDefinition/eclaire-arm-intervention #xD; Documentation for this format
Profil de ResearchStudy pour le projet ECLAIRE
Investigation to increase healthcare-related patient-independent knowledge
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.
Need to make sure we encompass public health studies.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
not(parent::f:contained and f:contained)
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()
not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))
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()
not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
If a resource is contained in another resource, it SHALL NOT have a security label
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
Observation[classCode=CLNTRL, moodCode=EVN]
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
The 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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
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.
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.
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
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
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.
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.
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.
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.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
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.
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Date de dernière modification substancielle
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
Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout la date d'approbation du comité éthique
Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout du domaine thérapeutique concerné par l'essai
Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout de la période prévisionnelle de recrutement l'essai
Statut du recrutement / Recruitment status
Extension créée dans le cadre du projet ECLAIRE pour indiquer le statut du recrutement
Texte bref décrivant l'essai / Brief text explaining the study (Brief summary)
Cette extension implemente l'élément descriptionSummary de R5 https://hl7.org/fhir/R5/researchstudy-definitions.html#ResearchStudy.descriptionSummary. elle permet l'ajout d'un texte bref décrivant l'essai (Brief summary)
Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)
Cette extension implemente l'élément outcomeMeasure de R5. elle permet l'ajout des conséquences principales et secondaires de l'essai
Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties
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
Autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5
Cette extension implemente l'élément label de R5. elle permet l'ajout de plusieurs titres pour l'essai
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).
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Slicing pour les différents identifiants de l'essai clinique
Identifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
CX / EI (occasionally, more often EI maps to a resource id or a URL)
II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT]
Organization's Unique Protocol ID; Secondary IDs
No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
Identifiant primaire de l'essai clinique / Primary Registry and Trial Identifying Number
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
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.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
fhir:CodeableConcept rdfs:subClassOf dt:CD
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Identifier.system is always case sensitive.
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.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
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](http://hl7.org/fhir/R4/datatypes.html#Duration).
If present, start SHALL have a lower value than end
start.hasValue().not() or end.hasValue().not() or (start <= end)
not(exists(f:start/@value)) or not(exists(f:end/@value)) or (xs:dateTime(f:start/@value) <= xs:dateTime(f:end/@value))
IVL<TS>[lowClosed="true" and highClosed="true"] or URG<TS>[lowClosed="true" and highClosed="true"]
Role.effectiveTime or implied by context
Date d'inscription au registre principal / Date of Registration in Primary Registry
The start of the period. The boundary is inclusive.
If the low element is missing, the meaning is that the low boundary is not known.
End time with inclusive boundary, if not ongoing
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.
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.
If the end of the period is missing, it means that the period is ongoing
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
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'))
not(starts-with(f:reference/@value, '#')) or exists(ancestor::*[self::f:entry or self::f:parameter]/f:resource/f:*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')]|/*/f:contained/f:*[f:id/@value=substring-after(current()/f:reference/@value, '#')])
The target of a resource reference is a RIM entry point (Act, Role, or Entity)
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
identifiants 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.
Nom scientifique de l'étude / Scientific Title
A short, descriptive user-friendly label for the study.
Note that FHIR strings SHALL NOT exceed 1MB in size
No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
The set of steps expected to be performed as part of the execution of the study.
References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository.
Interventions; Arm/Intervention Cross-Reference
A larger research study of which this particular study is a component or step.
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
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
Codes that convey the current status of the research study.
The type of study based upon the intent of the study's activities. A classification of the intent of the study.
Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination.
The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Type d'essai / Study type : type of study
Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Codes for medications, devices and other interventions.
Slicing pour apporter des précisions sur le sujet / Health Condition(s) or Problem(s) Studied. Dans le CTIS, il y a un champ texte ouvert (obligatoire) pour indiquer la pathologie et éventuellement des précisons. Un code MedDRA peut-être ajouté mais il est optionnel. Ainsi la slice medDRACondition contient un code meddra, la slice diseaseCondition contient un texte libre.
Sujet concerné / Problem(s) Studied exemple code MedDRA
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.
Identification of the condition or diagnosis.
A reference to a code defined by a terminology system.
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.
Allows for alternative encodings within a code system, and translations to other code systems.
CE/CNE/CWE subset one of the sets of component 1-3 or 4-6
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
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.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
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.
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.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
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).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
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.
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.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
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.
Very often the text is the same as a displayName of one of the codings.
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.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
condition de la pathologie / Disease Condition
Contact (Contact for public / scientific queries)
Contact details to assist a user in learning more about or engaging with the study.
Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact & Backup (if Study tied to only one location); Investigators
PointOfContact > Project > Research Project > Study > StudyProtocol > StudyProtocolVersion
Extension créée dans le cadre du projet ECLAIRE qui indique le type de Contact : Public ou Scientific
Extension créée dans le cadre du projet ECLAIRE pour indiquer l'adresse du contact
Extension créée dans le cadre du projet ECLAIRE pour indiquer l'affiliation du contact
Extension créée dans le cadre du projet ECLAIRE pour indiquer le nom de contact
If there is no named individual, the telecom information is for the organization as a whole.
Contact details for individual or organization
The contact details for the individual (if a name was provided) or the organization.
A system is required if a value is provided.
not(exists(f:value)) or exists(f:system)
Publications et résumé des résultats / Publications about the study and Summary results
Citations, references and other related documents.
Each related artifact is either an attachment, or a reference to another knowledge resource, but not both.
Citations, Links, Available Study Data/Documents
StudyProtocolDocument, StudyProtocolDocumentVersion
Key terms to aid in searching for or filtering the study.
Words associated with the study that may be useful in discovery.
DocumentVersion.keywordCode; DocumentVersion.keywordText
Pays de recrutement / Countries of Recruitment
Indicates a country, state or other region where the study is taking place.
Countries and regions within which this artifact is targeted for use.
Résumé de l'essai (description, durée de participation à l'essai clinique,etc) / Summary Results
A full description of how the study is being conducted.
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/
Critères d'inclusion et d'exclusion / Inclusion & exclusion criteria
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".
The Group referenced should not generally enumerate specific subjects. Subjects will be linked to the study using the ResearchSubject resource.
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
Identifies the start date and the expected (or actual, depending on status) end date for the study.
Study Start Date (start); Study Completion Date (end)
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
Date à laquelle l'essai se termine (la date initiale est prévisionnelle) / Completion date
Organization that initiates and is legally responsible for the study
An organization that initiates the investigation and is legally responsible for the study.
RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode
Researcher who oversees multiple aspects of the study
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.
A facility in which study activities are conducted.
accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
A description and/or code explaining the premature termination of the study.
Codes for why the study ended prematurely.
Comments made about the study by the performer, subject or other participants.
For systems that do not have structured annotations, they can simply communicate a single annotation with no author or time. This element may need to be included in narrative because of the potential for modifying information. *Annotations SHOULD NOT* be used to communicate "modifying" information that could be computable. (This is a SHOULD because enforcing user behavior is nearly impossible).
.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
Defined path through the study for a subject
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.
Intervention / For each arm of the trial record a brief intervention name plus an intervention description.
Extension créée dans le cadre du projet ECLAIRE pour indiquer les 'Interventions' dans les cohortes
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Unique, human-readable label for this arm of the study.
Categorization of study arm, e.g. experimental, active comparator, placebo comparater.
A succinct description of the path through the study that would be followed by a subject adhering to this arm.
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.
Unique, human-readable label for this objective of the study.
No BRIDG mapping (BRIDG has a description, but not a name)