diff --git a/files/CDISC_Pilot_Study_v4_FIXED.json b/files/CDISC_Pilot_Study_v4_FIXED.json index 4c30196..3137d61 100644 --- a/files/CDISC_Pilot_Study_v4_FIXED.json +++ b/files/CDISC_Pilot_Study_v4_FIXED.json @@ -999,7 +999,11 @@ "description": "", "previousId": null, "nextId": "Activity_1", - "childIds": ["Activity_1","Activity_2","Activity_3"], + "childIds": [ + "Activity_1", + "Activity_2", + "Activity_3" + ], "definedProcedures": [], "biomedicalConceptIds": [], "bcCategoryIds": [], @@ -1056,7 +1060,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1093,7 +1098,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1109,7 +1115,11 @@ "description": "", "previousId": "Activity_3", "nextId": "Activity_4", - "childIds": ["Activity_4","Activity_4b","Activity_7"], + "childIds": [ + "Activity_4", + "Activity_4b", + "Activity_7" + ], "definedProcedures": [], "biomedicalConceptIds": [], "bcCategoryIds": [], @@ -1148,7 +1158,10 @@ "description": "", "previousId": "Activity_4", "nextId": "Activity_5", - "childIds": ["Activity_5","Activity_6"], + "childIds": [ + "Activity_5", + "Activity_6" + ], "definedProcedures": [], "biomedicalConceptIds": [], "bcCategoryIds": [], @@ -1170,7 +1183,8 @@ "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_2"], + "BiomedicalConceptSurrogate_2" + ], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1188,7 +1202,8 @@ "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [ - "BiomedicalConceptSurrogate_3"], + "BiomedicalConceptSurrogate_3" + ], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1203,7 +1218,7 @@ "nextId": "Activity_8", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_5", "extensionAttributes": [], "name": "PR5", @@ -1222,9 +1237,11 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [ - "BiomedicalConcept_34"], + "BiomedicalConcept_34" + ], "bcCategoryIds": [], "bcSurrogateIds": [], "timelineId": null, @@ -1280,7 +1297,7 @@ "nextId": "Activity_11", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_6", "extensionAttributes": [], "name": "PR6", @@ -1299,7 +1316,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1319,7 +1337,9 @@ "definedProcedures": [], "biomedicalConceptIds": [], "bcCategoryIds": [], - "bcSurrogateIds": ["BiomedicalConceptSurrogate_4"], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_4" + ], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1334,7 +1354,7 @@ "nextId": "Activity_13", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_7", "extensionAttributes": [], "name": "PR7", @@ -1353,7 +1373,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1372,7 +1393,9 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [], - "bcCategoryIds": ["BCCat_1"], + "bcCategoryIds": [ + "BCCat_1" + ], "bcSurrogateIds": [], "timelineId": "ScheduleTimeline_3", "notes": [], @@ -1388,7 +1411,7 @@ "nextId": "Activity_15", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_8", "extensionAttributes": [], "name": "PR8", @@ -1407,7 +1430,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1425,7 +1449,7 @@ "nextId": "Activity_16", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_9", "extensionAttributes": [], "name": "PR9", @@ -1444,7 +1468,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1483,7 +1508,9 @@ "definedProcedures": [], "biomedicalConceptIds": [], "bcCategoryIds": [], - "bcSurrogateIds": ["BiomedicalConceptSurrogate_5"], + "bcSurrogateIds": [ + "BiomedicalConceptSurrogate_5" + ], "timelineId": null, "notes": [], "instanceType": "Activity" @@ -1575,7 +1602,9 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [], - "bcCategoryIds": ["BCCat_3"], + "bcCategoryIds": [ + "BCCat_3" + ], "bcSurrogateIds": [], "timelineId": null, "notes": [], @@ -1592,7 +1621,9 @@ "childIds": [], "definedProcedures": [], "biomedicalConceptIds": [], - "bcCategoryIds": ["BCCat_4"], + "bcCategoryIds": [ + "BCCat_4" + ], "bcSurrogateIds": [], "timelineId": null, "notes": [], @@ -1608,7 +1639,7 @@ "nextId": "Activity_24", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_10", "extensionAttributes": [], "name": "PR10", @@ -1627,7 +1658,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1664,7 +1696,7 @@ "nextId": "Activity_26", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_11", "extensionAttributes": [], "name": "PR11", @@ -1684,7 +1716,7 @@ "notes": [], "instanceType": "Procedure" }, - { + { "id": "Procedure_12", "extensionAttributes": [], "name": "PR12", @@ -1703,7 +1735,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1721,7 +1754,7 @@ "nextId": "Activity_27", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_13", "extensionAttributes": [], "name": "PR13", @@ -1740,7 +1773,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -1856,7 +1890,7 @@ "nextId": "Activity_32b", "childIds": [], "definedProcedures": [ - { + { "id": "Procedure_14", "extensionAttributes": [], "name": "PR14", @@ -1875,7 +1909,8 @@ "studyInterventionId": null, "notes": [], "instanceType": "Procedure" - }], + } + ], "biomedicalConceptIds": [], "bcCategoryIds": [], "bcSurrogateIds": [], @@ -2045,7 +2080,9 @@ "decode": "Data Generated Within Study", "instanceType": "Code" }, - "populationIds": ["StudyCohort_1"], + "populationIds": [ + "StudyCohort_1" + ], "notes": [], "instanceType": "StudyArm" }, @@ -2989,23 +3026,23 @@ }, "plannedSex": [ { - "id": "Code_620_b", - "extensionAttributes": [], - "code": "C16576", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Female", - "instanceType": "Code" - }, - { - "id": "Code_620_d", - "extensionAttributes": [], - "code": "C20197", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Male", - "instanceType": "Code" - } + "id": "Code_620_b", + "extensionAttributes": [], + "code": "C16576", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Female", + "instanceType": "Code" + }, + { + "id": "Code_620_d", + "extensionAttributes": [], + "code": "C20197", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Male", + "instanceType": "Code" + } ], "criterionIds": [ "EligibilityCriterion_1", @@ -3106,7 +3143,9 @@ "notes": [], "instanceType": "StudyCohort", "characteristics": [], - "indicationIds": ["Indication_1"] + "indicationIds": [ + "Indication_1" + ] }, { "id": "StudyCohort_2", @@ -3123,7 +3162,9 @@ "notes": [], "instanceType": "StudyCohort", "characteristics": [], - "indicationIds": ["Indication_2"] + "indicationIds": [ + "Indication_2" + ] } ] }, @@ -3974,13 +4015,15 @@ "defaultConditionId": "ScheduledActivityInstance_20", "epochId": "StudyEpoch_3", "instanceType": "ScheduledDecisionInstance", - "conditionAssignments": [{ + "conditionAssignments": [ + { "id": "ConditionAssignment_1", "extensionAttributes": [], "condition": "not willing to do online questionnaire", "conditionTargetId": "ScheduledActivityInstance_21", "instanceType": "ConditionAssignment" - }] + } + ] }, { "id": "ScheduledActivityInstance_20", @@ -5452,7 +5495,7 @@ "label": null, "description": null, "text": "

CNS imaging (CT scan or MRI of brain) compatible with AD within past 1 year.

", - "dictionaryId": null, + "dictionaryId": null, "notes": [], "instanceType": "EligibilityCriterionItem" }, @@ -5738,7 +5781,7 @@ "label": null, "description": null, "text": "

Treatment with the following medications within the specified washout periods prior to enrollment and during the\n study:

", - "dictionaryId": null, + "dictionaryId": null, "notes": [], "instanceType": "EligibilityCriterionItem" } @@ -5931,7 +5974,7 @@ "extensionAttributes": [], "name": "NCI_27", "text": "

The following measures will be performed in the course of the study. At Visits 3, 8, 10, and 12, ADAS-Cog, CIBIC+, and DAD will be administered. NPI-X will be administered at 2-week intervals either at clinic visits or via a telephone interview

", - "instanceType": "NarrativeContentItem" + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_28", @@ -5994,21 +6037,21 @@ "extensionAttributes": [], "name": "NCI_36", "text": "
Patients experiencing Rash and/or Eosinophilia\n

The administration of placebo and xanomeline TTS is associated with a rash and/or eosinophilia in some patients. The rash is characterized in the following ways:

", - "instanceType": "NarrativeContentItem" + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_37", "extensionAttributes": [], "name": "NCI_37", "text": "

Patient should lie

", - "instanceType": "NarrativeContentItem" + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_38", "extensionAttributes": [], "name": "NCI_38", "text": "

Cardiovascular status will be assessed during the trial

", - "instanceType": "NarrativeContentItem" + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_39", @@ -6057,13 +6100,14 @@ "extensionAttributes": [], "name": "NCI_45", "text": "

Patients who successfully complete the study...

", - "instanceType": "NarrativeContentItem" + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_46", "extensionAttributes": [], "name": "NCI_46", - "text": "

Because patients enrolled in this study will be outpatients

","instanceType": "NarrativeContentItem" + "text": "

Because patients enrolled in this study will be outpatients

", + "instanceType": "NarrativeContentItem" }, { "id": "NarrativeContentItem_47", @@ -6427,7 +6471,8 @@ "expandedText": "pharmacokinetics", "notes": [], "instanceType": "Abbreviation" - }], + } + ], "roles": [ { "id": "StudyRole_1", @@ -6444,7 +6489,9 @@ "decode": "Sponsor", "instanceType": "Code" }, - "appliesToIds": ["StudyVersion_1"], + "appliesToIds": [ + "StudyVersion_1" + ], "assignedPersons": [], "organizationIds": [ "Organization_1" @@ -6458,7 +6505,7 @@ }, "notes": [], "instanceType": "StudyRole" - }, + }, { "id": "StudyRole_2", "extensionAttributes": [], @@ -6474,24 +6521,31 @@ "decode": "Investigator", "instanceType": "Code" }, - "appliesToIds": ["InterventionalStudyDesign_1"], - "assignedPersons": [{ - "id": "Pers_001", - "name": "INV01", - "label": null, - "description": null, - "personName": { - "id": "PN_001", - "text": "Mr. X", - "familyName": "X", - "givenNames": ["Ab","Theo"], - "prefixes": [], - "suffixes": [], - "instanceType": "PersonName" - }, - "jobTitle": "Physician", - "instanceType": "AssignedPerson" - }], + "appliesToIds": [ + "InterventionalStudyDesign_1" + ], + "assignedPersons": [ + { + "id": "Pers_001", + "name": "INV01", + "label": null, + "description": null, + "personName": { + "id": "PN_001", + "text": "Mr. X", + "familyName": "X", + "givenNames": [ + "Ab", + "Theo" + ], + "prefixes": [], + "suffixes": [], + "instanceType": "PersonName" + }, + "jobTitle": "Physician", + "instanceType": "AssignedPerson" + } + ], "organizationIds": [], "masking": { "id": "Masking_2", @@ -7204,20 +7258,20 @@ "label": "Xanomeline", "description": null, "administrableDoseForm": { - "id": "AliasCode_p01", - "extensionAttributes": [], - "standardCode": { - "id": "Code_p01", - "extensionAttributes": [], - "code": "C42968", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "PATCH", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, + "id": "AliasCode_p01", + "extensionAttributes": [], + "standardCode": { + "id": "Code_p01", + "extensionAttributes": [], + "code": "C42968", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "PATCH", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, "sourcing": { "id": "Code_p02", "extensionAttributes": [], @@ -7237,229 +7291,239 @@ "instanceType": "Code" }, "pharmacologicClass": null, - "properties": [{ + "properties": [ + { "id": "AdmProdProp_1", "extensionAttributes": [], "name": "AdmProdProp1", "type": { - "id": "Code_p04", - "extensionAttributes": [], - "code": "C45997", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "pH", - "instanceType": "Code" + "id": "Code_p04", + "extensionAttributes": [], + "code": "C45997", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "pH", + "instanceType": "Code" }, "text": "7.0", - "quantity": null, + "quantity": null, "instanceType": "AdministrableProductProperty" - }], - "ingredients": [{ - "id": "Ingredient_1", - "role": { - "id": "Code_rol03", - "extensionAttributes": [], - "code": " 100000072072", - "codeSystem": "http://hl7/org/fhir", - "codeSystemVersion": "5.0.0", - "decode": "Active", - "instanceType": "Code" + } + ], + "ingredients": [ + { + "id": "Ingredient_1", + "role": { + "id": "Code_rol03", + "extensionAttributes": [], + "code": " 100000072072", + "codeSystem": "http://hl7/org/fhir", + "codeSystemVersion": "5.0.0", + "decode": "Active", + "instanceType": "Code" + }, + "substance": { + "id": "Subst_01", + "extensionAttributes": [], + "name": "SUBST01", + "label": null, + "description": null, + "referenceSubstance": { + "id": "Subst_02", + "extensionAttributes": [], + "name": "SUBST02", + "codes": [], + "referenceSubstance": null, + "strengths": [ + { + "id": "Str_01r", + "name": "STRENGTH01_Ref", + "numerator": { + "id": "Range_1_inRef", + "extensionAttributes": [], + "minValue": { + "id": "Quantity_9_inRef", + "extensionAttributes": [], + "value": 50.0, + "unit": { + "id": "AliasCode_251_inRef", + "extensionAttributes": [], + "standardCode": { + "id": "Code_618_inRef", + "extensionAttributes": [], + "code": "C28253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milligram", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "maxValue": { + "id": "Quantity_10_inRef", + "extensionAttributes": [], + "value": 100.0, + "unit": { + "id": "AliasCode_252_inRef", + "extensionAttributes": [], + "standardCode": { + "id": "Code_619_inRef", + "extensionAttributes": [], + "code": "C28253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milligram", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "isApproximate": false, + "instanceType": "Range" + }, + "denominator": { + "id": "Q_d3", + "extensionAttributes": [], + "value": 2.0, + "unit": { + "id": "AliasCode_243_d", + "extensionAttributes": [], + "standardCode": { + "id": "C_607d", + "extensionAttributes": [], + "code": "C28254", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milliliter", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "instanceType": "Strength" + } + ], + "instanceType": "Substance" + }, + "codes": [], + "strengths": [ + { + "id": "Str_01", + "name": "STRENGTH01", + "label": null, + "description": null, + "numerator": { + "id": "Range_1_in", + "extensionAttributes": [], + "minValue": { + "id": "Quantity_9_in", + "extensionAttributes": [], + "value": 50.0, + "unit": { + "id": "AliasCode_251_in", + "extensionAttributes": [], + "standardCode": { + "id": "Code_618_in", + "extensionAttributes": [], + "code": "C28253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milligram", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "maxValue": { + "id": "Quantity_10_in", + "extensionAttributes": [], + "value": 100.0, + "unit": { + "id": "AliasCode_252_in", + "extensionAttributes": [], + "standardCode": { + "id": "Code_619_in", + "extensionAttributes": [], + "code": "C28253", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milligram", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "isApproximate": false, + "instanceType": "Range" + }, + "denominator": { + "id": "Quantity_d3", + "extensionAttributes": [], + "value": 2.0, + "unit": { + "id": "AC_243_d", + "extensionAttributes": [], + "standardCode": { + "id": "Code_607d", + "extensionAttributes": [], + "code": "C28254", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Milliliter", + "instanceType": "Code" + }, + "standardCodeAliases": [], + "instanceType": "AliasCode" + }, + "instanceType": "Quantity" + }, + "instanceType": "Strength" + } + ], + "instanceType": "Substance" }, - "substance": { - "id": "Subst_01", - "extensionAttributes": [], - "name": "SUBST01", - "label": null, - "description": null, - "referenceSubstance": { - "id": "Subst_02", - "extensionAttributes": [], - "name": "SUBST02", - "codes": [], - "referenceSubstance": null, - "strengths":[{ - "id": "Str_01r", - "name": "STRENGTH01_Ref", - "numerator": { - "id": "Range_1_inRef", - "extensionAttributes": [], - "minValue": { - "id": "Quantity_9_inRef", - "extensionAttributes": [], - "value": 50.0, - "unit": { - "id": "AliasCode_251_inRef", - "extensionAttributes": [], - "standardCode": { - "id": "Code_618_inRef", - "extensionAttributes": [], - "code": "C28253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milligram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "maxValue": { - "id": "Quantity_10_inRef", - "extensionAttributes": [], - "value": 100.0, - "unit": { - "id": "AliasCode_252_inRef", - "extensionAttributes": [], - "standardCode": { - "id": "Code_619_inRef", - "extensionAttributes": [], - "code": "C28253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milligram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "isApproximate": false, - "instanceType": "Range" - }, - "denominator": { - "id": "Q_d3", - "extensionAttributes": [], - "value": 2.0, - "unit": { - "id": "AliasCode_243_d", - "extensionAttributes": [], - "standardCode": { - "id": "C_607d", - "extensionAttributes": [], - "code": "C28254", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milliliter", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "instanceType": "Strength" - }], - "instanceType": "Substance" - } , - "codes": [], - "strengths":[{ - "id": "Str_01", - "name": "STRENGTH01", - "label": null, - "description": null, - "numerator": { - "id": "Range_1_in", - "extensionAttributes": [], - "minValue": { - "id": "Quantity_9_in", - "extensionAttributes": [], - "value": 50.0, - "unit": { - "id": "AliasCode_251_in", - "extensionAttributes": [], - "standardCode": { - "id": "Code_618_in", - "extensionAttributes": [], - "code": "C28253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milligram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "maxValue": { - "id": "Quantity_10_in", - "extensionAttributes": [], - "value": 100.0, - "unit": { - "id": "AliasCode_252_in", - "extensionAttributes": [], - "standardCode": { - "id": "Code_619_in", - "extensionAttributes": [], - "code": "C28253", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milligram", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "isApproximate": false, - "instanceType": "Range" - }, - "denominator": { - "id": "Quantity_d3", - "extensionAttributes": [], - "value": 2.0, - "unit": { - "id": "AC_243_d", - "extensionAttributes": [], - "standardCode": { - "id": "Code_607d", - "extensionAttributes": [], - "code": "C28254", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Milliliter", - "instanceType": "Code" - }, - "standardCodeAliases": [], - "instanceType": "AliasCode" - }, - "instanceType": "Quantity" - }, - "instanceType": "Strength" - }], - "instanceType": "Substance" - }, - "instanceType": "Ingredient" - }], + "instanceType": "Ingredient" + } + ], "notes": [], "instanceType": "AdministrableProduct" - }], + } + ], "medicalDevices": [], "productOrganizationRoles": [ - { - "id": "ProductRole_1", - "name": "RoleName_1", - "label": "Sponsor Manufacturer", - "description": null, - "code": - { - "id": "Code_pr001", - "extensionAttributes": [], - "code": "C25392", - "codeSystem": "http://www.cdisc.org", - "codeSystemVersion": "2025-09-26", - "decode": "Manufacturer", - "instanceType": "Code" + { + "id": "ProductRole_1", + "name": "RoleName_1", + "label": "Sponsor Manufacturer", + "description": null, + "code": { + "id": "Code_pr001", + "extensionAttributes": [], + "code": "C25392", + "codeSystem": "http://www.cdisc.org", + "codeSystemVersion": "2025-09-26", + "decode": "Manufacturer", + "instanceType": "Code" }, - "organizationId": "Organization_1", - "appliesToIds": ["AdmProd_1"], - "instanceType": "ProductOrganizationRole" - }], + "organizationId": "Organization_1", + "appliesToIds": [ + "AdmProd_1" + ], + "instanceType": "ProductOrganizationRole" + } + ], "biomedicalConcepts": [ - { "id": "BiomedicalConcept_20", "extensionAttributes": [], @@ -17566,53 +17630,74 @@ "instanceType": "BiomedicalConcept" } ], - "bcCategories": [{ + "bcCategories": [ + { "id": "BCCat_1", - "name": "VS_Cat1", - "extensionAttributes": [], - "description": "Vital signs including SBP/DBP, Temp, Weight", - "label": "Vital Signs Category", + "name": "VS_Cat1", + "extensionAttributes": [], + "description": "Vital signs including SBP/DBP, Temp, Weight", + "label": "Vital Signs Category", "code": null, - "childIds": [], - "memberIds": ["BiomedicalConcept_2","BiomedicalConcept_3","BiomedicalConcept_4","BiomedicalConcept_5"], + "childIds": [], + "memberIds": [ + "BiomedicalConcept_2", + "BiomedicalConcept_3", + "BiomedicalConcept_4", + "BiomedicalConcept_5" + ], "instanceType": "BiomedicalConceptCategory", - "notes": [] - }, { + "notes": [] + }, + { "id": "BCCat_2", - "name": "VS_Cat2", - "extensionAttributes": [], - "description": "Vital signs including SBP/DBP, HR", - "label": "Vital Signs Category", + "name": "VS_Cat2", + "extensionAttributes": [], + "description": "Vital signs including SBP/DBP, HR", + "label": "Vital Signs Category", "code": null, - "childIds": [], - "memberIds": ["BiomedicalConcept_2","BiomedicalConcept_3","BiomedicalConcept_16"], + "childIds": [], + "memberIds": [ + "BiomedicalConcept_2", + "BiomedicalConcept_3", + "BiomedicalConcept_16" + ], "instanceType": "BiomedicalConceptCategory", - "notes": [] + "notes": [] }, - { + { "id": "BCCat_3", - "name": "Chem_Cat1", - "extensionAttributes": [], - "description": "Biochemistry including ALAT, Alk.Phos, ASAT", - "label": "Biochemistry Category", + "name": "Chem_Cat1", + "extensionAttributes": [], + "description": "Biochemistry including ALAT, Alk.Phos, ASAT", + "label": "Biochemistry Category", "code": null, - "childIds": [], - "memberIds": ["BiomedicalConcept_7","BiomedicalConcept_9","BiomedicalConcept_10"], + "childIds": [], + "memberIds": [ + "BiomedicalConcept_7", + "BiomedicalConcept_9", + "BiomedicalConcept_10" + ], "instanceType": "BiomedicalConceptCategory", - "notes": [] + "notes": [] }, - { + { "id": "BCCat_4", - "name": "Urin_Cat1", - "extensionAttributes": [], - "description": "Urinalysis including Albumin, Creatinin, Potassium and Sodium", - "label": "Biochemistry Category", + "name": "Urin_Cat1", + "extensionAttributes": [], + "description": "Urinalysis including Albumin, Creatinin, Potassium and Sodium", + "label": "Biochemistry Category", "code": null, - "childIds": [], - "memberIds": ["BiomedicalConcept_8","BiomedicalConcept_11","BiomedicalConcept_12","BiomedicalConcept_13"], + "childIds": [], + "memberIds": [ + "BiomedicalConcept_8", + "BiomedicalConcept_11", + "BiomedicalConcept_12", + "BiomedicalConcept_13" + ], "instanceType": "BiomedicalConceptCategory", - "notes": [] - }], + "notes": [] + } + ], "bcSurrogates": [ { "id": "BiomedicalConceptSurrogate_1", @@ -17624,7 +17709,7 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" }, - { + { "id": "BiomedicalConceptSurrogate_2", "extensionAttributes": [], "name": "Haschinki", @@ -17634,7 +17719,7 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" }, - { + { "id": "BiomedicalConceptSurrogate_3", "extensionAttributes": [], "name": "MMSE", @@ -17644,7 +17729,7 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" }, - { + { "id": "BiomedicalConceptSurrogate_4", "extensionAttributes": [], "name": "ApoE", @@ -17654,7 +17739,7 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" }, - { + { "id": "BiomedicalConceptSurrogate_5", "extensionAttributes": [], "name": "TTS", @@ -17664,8 +17749,6 @@ "notes": [], "instanceType": "BiomedicalConceptSurrogate" } - - ], "dictionaries": [ { diff --git a/requirements.txt b/requirements.txt index 7b7968f..3e9ea6f 100644 --- a/requirements.txt +++ b/requirements.txt @@ -1,60 +1,25 @@ -annotated-doc==0.0.3 annotated-types==0.7.0 -anyio==4.11.0 -black==25.9.0 -certifi==2025.10.5 -cfgv==3.5.0 +beautifulsoup4==4.14.3 +certifi==2026.1.4 charset-normalizer==3.4.4 -click==8.3.0 -detect-secrets==1.5.0 -distlib==0.4.0 +docraptor==3.1.0 et_xmlfile==2.0.0 -fastapi==0.121.0 -filelock==3.20.0 -flake8==7.3.0 -h11==0.16.0 -httpcore==1.0.9 -httpx==0.28.1 -identify==2.6.15 +fhir.resources==8.2.0 +fhir_core==1.1.5 idna==3.11 -iniconfig==2.3.0 -Jinja2==3.1.6 -MarkupSafe==3.0.3 -mccabe==0.7.0 -mypy_extensions==1.1.0 -nodeenv==1.9.1 -numpy==1.26.4 +numpy==2.4.2 openpyxl==3.1.5 -packaging==25.0 -pandas==2.3.3 -pathspec==0.12.1 -pillow==12.0.0 -platformdirs==4.5.0 -pluggy==1.6.0 -pre_commit==4.4.0 -pycodestyle==2.14.0 -pydantic==2.12.3 -pydantic_core==2.41.4 -pyflakes==3.4.0 -Pygments==2.19.2 -pytest==8.4.2 +pandas==3.0.0 +pydantic==2.12.5 +pydantic_core==2.41.5 python-dateutil==2.9.0.post0 -python-dotenv==1.2.1 -python-multipart==0.0.20 -pytokens==0.2.0 -pytz==2025.2 PyYAML==6.0.3 -reportlab==4.4.5 requests==2.32.5 -ruff==0.14.3 six==1.17.0 -sniffio==1.3.1 --e git+https://github.com/pendingintent/soa-workbench.git@1519f7e05851d4800999ec0b66ce77b4bf5646b5#egg=soa_builder -starlette==0.49.3 +soupsieve==2.8.3 +stringcase==1.2.0 typing-inspection==0.4.2 typing_extensions==4.15.0 -tzdata==2025.2 -urllib3==2.5.0 -uvicorn==0.38.0 -virtualenv==20.35.4 -xlrd==2.0.1 +urllib3==2.6.3 +usdm==0.66.0 +yattag==1.16.1