Sd add associated party r5 (#123)

* Sd add ext consequences principales et secondaires (#121) (#122) * add extension et VS --------- Co-authored-by: sly-kereval <125375447+sly-kereval@users.noreply.github.com> * add extensions VS et CS 1st iteration * typos * Maj mapping associatedParty * url canonique CS VS * typo --------- Co-authored-by: sly-kereval <125375447+sly-kereval@users.noreply.github.com>
ansforge · Feb 16, 2024 · a66e58c · a66e58c
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diff --git a/input/fsh/CodeSystem/EclaireStudyPartyOrganizationTypeCS.fsh 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"
diff --git a/input/fsh/CodeSystem/EclaireStudyPartyRoleCS.fsh 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"
diff --git a/input/fsh/StructureDefinition/extensions/ECLAIREApprovalDate.fsh 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
diff --git a/input/fsh/StructureDefinition/extensions/ECLAIRESecondarySponsor.fsh b/input/fsh/StructureDefinition/extensions/ECLAIRESecondarySponsor.fsh
diff --git a/input/fsh/StructureDefinition/extensions/ECLAIREassociatedPartyR5.fsh 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)"
diff --git 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
@@ -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
diff --git a/input/fsh/ValueSet/EclaireStudyPartyRoleVS.fsh 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
diff --git 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
@@ -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..*]