diff --git a/input/fsh/CodeSystem/EclaireStudyPartyOrganizationTypeCS.fsh b/input/fsh/CodeSystem/EclaireStudyPartyOrganizationTypeCS.fsh new file mode 100644 index 000000000..0a20929a2 --- /dev/null +++ b/input/fsh/CodeSystem/EclaireStudyPartyOrganizationTypeCS.fsh @@ -0,0 +1,9 @@ +CodeSystem: EclaireStudyPartyOrganizationTypeCS +Id: eclaire-study-party-organization-type-code-system +Title: "Définition des différents types d'organisation des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-organization-type" +Description: "Différents rôles des parties impliquées dans l'essai" +* ^caseSensitive = true +* #government "Gouvernemental / Government" +* #nonprofit "Sans but lucratif / Nonprofit" +* #academic "Académique / Academic" +* #industry "Industriel / Industry" \ No newline at end of file diff --git a/input/fsh/CodeSystem/EclaireStudyPartyRoleCS.fsh b/input/fsh/CodeSystem/EclaireStudyPartyRoleCS.fsh new file mode 100644 index 000000000..ec0a63790 --- /dev/null +++ b/input/fsh/CodeSystem/EclaireStudyPartyRoleCS.fsh @@ -0,0 +1,17 @@ +CodeSystem: EclaireStudyPartyRoleCS +Id: eclaire-study-party-role-code-system +Title: "Définition des rôles des parties prenantes inspiré de http://hl7.org/fhir/research-study-party-role" +Description: "Différents rôles des parties impliqué dans l'essai" +* ^caseSensitive = true +* #sponsor "sponsor" "sponsor" +* #lead-sponsor "lead-sponsor" "lead-sponsor" +* #sponsor-investigator "sponsor-investigator" "sponsor-investigator" +* #primary-investigator "primary-investigator" "primary-investigator" +* #collaborator "collaborator" "collaborator" +* #funding-source "funding-source" "funding-source" +* #general-contact "general-contact" "general-contact" +* #recruitment-contact "recruitment-contact" "recruitment-contact" +* #sub-investigator "sub-investigator" "sub-investigator" +* #study-director "study-director" "study-director" +* #study-chair "study-chair" "study-chair" +* #ethics "Ethics Review Board" "Ethics Review Board" \ No newline at end of file diff --git a/input/fsh/StructureDefinition/extensions/ECLAIREApprovalDate.fsh b/input/fsh/StructureDefinition/extensions/ECLAIREApprovalDate.fsh new file mode 100644 index 000000000..7ac9aec91 --- /dev/null +++ b/input/fsh/StructureDefinition/extensions/ECLAIREApprovalDate.fsh @@ -0,0 +1,6 @@ +Extension: ECLAIREApprovalDate +Id: eclaire-approval-date +Description: "Extension créée dans le cadre du projet API ECLAIRE afin de permettre l'ajout la date d'approbation du comité éthique" +* ^context.type = #element +* ^context.expression = "ResearchStudy" +* value[x] only instant \ No newline at end of file diff --git a/input/fsh/StructureDefinition/extensions/ECLAIRESecondarySponsor.fsh b/input/fsh/StructureDefinition/extensions/ECLAIRESecondarySponsor.fsh deleted file mode 100644 index cbf3db800..000000000 --- a/input/fsh/StructureDefinition/extensions/ECLAIRESecondarySponsor.fsh +++ /dev/null @@ -1,6 +0,0 @@ -Extension: ECLAIRESecondarySponsor -Id: eclaire-secondary-sponsor -Description: "Extension créée dans le cadre du projet API ECLAIRE afin de pouvoir renseigner le(s) promoteur(s) secondaire(s)" -* ^context.type = #element -* ^context.expression = "ResearchStudy" -* value[x] only Reference(Organization) \ No newline at end of file diff --git a/input/fsh/StructureDefinition/extensions/ECLAIREassociatedPartyR5.fsh b/input/fsh/StructureDefinition/extensions/ECLAIREassociatedPartyR5.fsh new file mode 100644 index 000000000..3af5e559a --- /dev/null +++ b/input/fsh/StructureDefinition/extensions/ECLAIREassociatedPartyR5.fsh @@ -0,0 +1,29 @@ +Extension: ECLAIREassociatedPartyR5 +Id: eclaire-associated-party-r5 +Description: "Extension créée dans le cadre du projet API ECLAIRE, afin de permettre l'ajout des Sponsors, collaborateurs et autres parties concernés par l'essai. Cette extension implemente l’élément associatedParty de R5 http://hl7.org/fhir/R5/researchstudy-definitions.html#ResearchStudy.associatedParty" +* ^context.type = #element +* ^context.expression = "ResearchStudy" +* ^url = $associated-party-r5 + +* extension contains + name 0..1 and + role 1..1 and + period 0..* and + classifier 0..* and + party 0..1 +* extension[name].value[x] only string +* extension[name] ^short = "Nom de la partie prenante / Name of associated party" + +* extension[role].value[x] only CodeableConcept +* extension[role] ^short = "sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-director | study-chair" +* extension[role].valueCodeableConcept from eclaire-study-party-role-vs (extensible) + +* extension[period].value[x] only Period +* extension[period] ^short = "Période définie pour ce role / When active in the role" + +* extension[classifier].value[x] only CodeableConcept +* extension[classifier] ^short = "government | nonprofit | academic | industry" +* extension[classifier].valueCodeableConcept from eclaire-study-party-organization-type-vs (extensible) + +* extension[party].value[x] only Reference(Practitioner or PractitionerRole or Organization) +* extension[party] ^short = "Structure de la partie prenante / Structured outcome definition Individual or organization associated with study (use practitionerRole to specify their organisation)" \ No newline at end of file diff --git a/input/fsh/StructureDefinition/profiles/ECLAIREResearchStudy.fsh b/input/fsh/StructureDefinition/profiles/ECLAIREResearchStudy.fsh index 7b479850d..31991bd26 100644 --- a/input/fsh/StructureDefinition/profiles/ECLAIREResearchStudy.fsh +++ b/input/fsh/StructureDefinition/profiles/ECLAIREResearchStudy.fsh @@ -28,8 +28,8 @@ Description: "Profil de ResearchStudy pour le projet ECLAIRE" * enrollment MS * site ^short = "Lieux / Countries of Recruitment" * site MS -* sponsor ^short = "Promoteur / primary Sponsor" -* sponsor MS +* sponsor 0..0 //remplacé par associatedParty +* principalInvestigator 0..0 //remplacé par associatedParty * location ^short = "Pays de recrutement / Countries of Recruitment" * location MS * relatedArtifact ^short = "Publications et résumé des résultats / Publications about the study and Summary results" @@ -70,27 +70,31 @@ Description: "Profil de ResearchStudy pour le projet ECLAIRE" /*Extensions*/ * extension contains ECLAIREReviewDate named eclaire-review-date 0..1 MS and + ECLAIREApprovalDate named eclaire-approval-date 0..1 MS and ECLAIRETherapeuticArea named eclaire-therapeutic-area 0..1 MS and ECLAIRERecruitmentPeriod named eclaire-recruitment-period 0..1 MS and - ECLAIRESecondarySponsor named eclaire-secondary-sponsor 0..* MS and ECLAIRERecruitmentStatus named eclaire-recruitment-status 0..1 MS and // en R5 le ProgressStatus inclut fonctionnelement le status de R4. Nous sommes donc obligés de faire cette extension en R4 pour répondre au besoin $description-summary-r5 named eclaire-description-summary-r5 0..1 MS and ECLAIREoutcomeMeasureR5 named eclaire-outcome-measure-r5 0..* MS and // extension outcomeMeasure inspirée de R5 + ECLAIREassociatedPartyR5 named eclaire-associated-party-r5 0..* MS and // extension associatedParty inspirée de R5 ECLAIRELabelR5 named eclaire-label-r5 0..* MS // extension label inspirée de R5 * extension[eclaire-review-date] ^short = "Date de dernière modification substancielle" +* extension[eclaire-approval-date] ^short = "Date d'approbation du comité éthique" * extension[eclaire-description-summary-r5] ^short = "Texte bref décrivant l'essai / Brief text explaining the study." * extension[eclaire-description-summary-r5] ^definition = "Cette extension implemente l'élément descriptionSummary de R5. elle permet l'ajout d'un texte bref décrivant l'essai" * extension[eclaire-description-summary-r5].valueMarkdown 1..1 * extension[eclaire-description-summary-r5].value[x] only markdown - * extension[eclaire-outcome-measure-r5] ^short = "Conséquences principales (primary outcomes) + Conséquences secondaires (secondary outcomes)" * extension[eclaire-outcome-measure-r5] ^definition = "Cette extension implemente l'élément outcomeMeasure de R5. elle permet l'ajout des conséquences principales et secondaires de l'essai" +* extension[eclaire-associated-party-r5] ^short = "Sponsor, collaborateurs et autres parties / Sponsors, collaborators, and other parties " +* extension[eclaire-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" + * extension[eclaire-label-r5] ^short = "Autres titres et acronyme / Additional names for the study. Implémentation de l'élément label de R5" * extension[eclaire-label-r5] ^definition = "Cette extension implemente l'élément label de R5. elle permet l'ajout de plusieurs titres pour l'essai" * extension[eclaire-therapeutic-area] ^short = "Domaine thérapeutique concerné" * extension[eclaire-recruitment-period] ^short = "Période prévisionnelle de recrutement" -* extension[eclaire-recruitment-status] ^short = "Statut du recrutement / Recruitment status" -* extension[eclaire-secondary-sponsor] ^short = "Promoteur(s) secondaire(s) / Secondary Sponsor(s)" +* extension[eclaire-recruitment-status] ^short = "Statut du recrutement / Recruitment status" + * contact.extension contains ECLAIREContactType named eclaire-contact-type 0..1 MS and ECLAIREContactAddress named eclaire-contact-address 0..1 MS and diff --git a/input/fsh/ValueSet/EclaireStudyPartyOrganizationTypeVS.fsh b/input/fsh/ValueSet/EclaireStudyPartyOrganizationTypeVS.fsh new file mode 100644 index 000000000..8aba97a99 --- /dev/null +++ b/input/fsh/ValueSet/EclaireStudyPartyOrganizationTypeVS.fsh @@ -0,0 +1,5 @@ +ValueSet: EclaireStudyPartyOrganizationTypeVS +Id: eclaire-study-party-organization-type-vs +Title: "Value Set Eclaire pour les types de parties" +Description: "Value Set Eclaire pour les types de parties impliquées dans l'essai." +* include codes from system eclaire-study-party-organization-type-code-system \ No newline at end of file diff --git a/input/fsh/ValueSet/EclaireStudyPartyRoleVS.fsh b/input/fsh/ValueSet/EclaireStudyPartyRoleVS.fsh new file mode 100644 index 000000000..82f2a76f2 --- /dev/null +++ b/input/fsh/ValueSet/EclaireStudyPartyRoleVS.fsh @@ -0,0 +1,5 @@ +ValueSet: EclaireStudyPartyRoleVS +Id: eclaire-study-party-role-vs +Title: "Value Set Eclaire pour les différents rôles des parties impliquées dans l'essai" +Description: "Value Set Eclaire pour les différents rôles des parties impliquées dans l'essai cliniques (sponsor, collaborateur, etc)." +* include codes from system eclaire-study-party-role-code-system \ No newline at end of file diff --git a/input/fsh/alias-eclaire.fsh b/input/fsh/alias-eclaire.fsh index ad42e09ca..83ecd202a 100644 --- a/input/fsh/alias-eclaire.fsh +++ b/input/fsh/alias-eclaire.fsh @@ -5,7 +5,7 @@ Alias: $label-r5 = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label Alias: $description-summary-r5 = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary Alias: $outcome-measure-r5 = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure - +Alias: $associated-party-r5 = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty // ---- Systems diff --git a/input/images-source/mapping.plantuml b/input/images-source/mapping.plantuml index e9b35de5d..f887f846e 100644 --- a/input/images-source/mapping.plantuml +++ b/input/images-source/mapping.plantuml @@ -101,8 +101,11 @@ map "EssaiClinique : ResearchStudy" as RS #back:AliceBlue;header:LightSkyBlue;li Participants (Key Inclusion and Exclusion Criteria, Sample size) => enrollment : Reference(Group) [0..*] Lieux => site : Reference(Location) [0..*] Pays de recrutement (Countries of Recruitment) => location : CodeableConcept [0..*] - Promoteur principal (Primary sponsor) => sponsor : Reference(Organization) [0..1] - Promoteur secondaire (Secondary Sponsor(s)) => <&plus> ECLAIRESecondarySponsor : Reference(Organization) [0..*] + Promoteur principal (Primary sponsor) => <&plus> ECLAIREassociatedPartyR5 : Extension R5 ResearchStudy.associatedParty [0..*] + Promoteur secondaire (Secondary Sponsor(s)) => <&plus> ECLAIREassociatedPartyR5 : Extension R5 ResearchStudy.associatedParty [0..*] + Source de financement (Source(s) of Monetary or Material Support) => <&plus> ECLAIREassociatedPartyR5 : Extension R5 ResearchStudy.associatedParty [0..*] + Comité éthique (Ethics Review Board) => <&plus> ECLAIREassociatedPartyR5 : Extension R5 ResearchStudy.associatedParty [0..*] + Date d'approbation du comité éthique => <&plus> ECLAIREApprovalDate : instant [0..1] Publications et résumé des résultats (Publications about the study and Summary results) => relatedArtifact : RelatedArtifact [0..*] Conséquences principales (Primary outcomes) et secondaires (Secondary outcomes) => <&plus> ECLAIREoutcomeMeasureR5 : Extension R5 ResearchStudy.outcomeMeasure [0..*] Cohorte => arm : BackboneElement [0..*]