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1 Ontology Development
- 1.1 Summary
- 1.2 Deprecated Resources
- 1.3 Comparison with the 0.2.0 version of the IDMP Ontology
  - 1.3.1 By the Numbers
  - 1.3.2 Detailed View
2 Competency Questions Unit Test
3 Ontology Quality Standards

Ontology Development

Summary

This quarter the development team made significant progress in several key areas, including:

Augmenting the ontologies to incorporate concepts and relationships needed to support Use Case 2 (UC-2), relating regulatory reporting requirements to the manufacturing side of the business, e.g., packaging concepts
Refactoring some of our original work to address areas where shortcuts had been taken for Phase 1, such as to better address the relationship between products and their ingredients
Refactoring to distinguish substance and product specifications from their physical counterparts
Adding initial support for molecular entities, including molecules and atoms

The work also involved revising our original set of competency questions and adding new ones for UC-2 as well as increasing support for mappings to EMA SPOR. We also added a new example from the EMA PMS Implementation Guide, Chapter 8, for Qlaira. This particular example, which is mapped to SPOR, is important because the same medicinal product includes several pharmaceutical products.

Deprecated Resources

The following resources were deprecated and may be deleted in the upcoming v0.4.0 release. These terms were deprecated as a consequence of (1) aligning the names of some concepts representing ingredient roles with the IDMP standard and common usage per SME review, (2) revising the names of product and substance constituencies to use the term 'composition', again due to common usage per SME review, and moving the term Specification to be more accessible as the basis for substance and product specification representation.

Resources
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ActiveIngredientRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/AdjuvantRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/ExcipientRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/InactiveIngredientRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/IngredientRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/SubstanceConstituency
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProductConstituency
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasActiveIngredientRole
https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasIngredientRole
https://spec.pistoiaalliance.org/idmp/ontology/META/ChangeManagement/Specification
https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/L001
https://www.omg.org/spec/LCC/Countries/ISO3166-1-CountryCodes/Montenegrin

Comparison with the 0.2.0 version of the IDMP Ontology

By the Numbers

One new ontology was added: QlairaExample.

The following ontologies were changed:

Ontology Short Name	New Resources	Deleted Resources	Modified Resources

Ontology Short Name	New Resources	Deleted Resources	Modified Resources
AboutIDMPDev	0	0	1
AboutIDMPDev-ReferenceIndividuals	0	0	1
AboutIDMPProd	0	0	1
AboutIDMPProd-ReferenceIndividuals	0	0	1
AmlodipineExample	37	4	11
ChangeManagement	0	0	3
Documents	4	0	1
EuropeanUnionClinicalTrialsRegister	3	4	0
GovernmentEntities	0	0	8
ISO11238-Substances	51	6	52
ISO11239-PharmaceuticalDoseForms	0	0	2
ISO11240-UnitsOfMeasurement	1	0	1
ISO11615-MedicinalProducts	26	1	27
MetadataEXT	0	0	2
MetadataIDMP	1	1	1
Organizations	0	0	7
ProductsAndServices	0	0	4
QuantitiesAndUnits	1	0	0
RegistrationAuthorities	0	1	3
RegulatoryAgencies	0	0	2
SubstancesProductsOrganisationsReferentials	20	1	5
TerlipressinExample	12	5	12

Detailed View

ontology	resources in v0.2.0 but not in v0.3.0 release

ontology	resources in v0.2.0 but not in v0.3.0 release
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/SPOR-SubstanceDomainClassifier
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMCConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateConstituency
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasIngredient
RegistrationAuthorities	https://www.omg.org/spec/Commons/RegistrationAuthorities/specifies
TerlipressinExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinAcetateSUN0.12MgPerMlSolutionForInjectionConstituency
TerlipressinExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinSUN1MgSolutionForInjectionConstituency
TerlipressinExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinAcetateConstituency
TerlipressinExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinSUN0.1MgPerMlSolutionForInjectionConstituency
TerlipressinExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/TerlipressinExample/TerlipressinAcetateSUNConstituency
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/hasMolecularFormula
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/isPublicDomain
ISO11238-Substances	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/hasMolecularFormulaByMoiety
MetadataIDMP	https://spec.pistoiaalliance.org/idmp/ontology/MetadataIDMP/IDMPSpecification
EuropeanUnionClinicalTrialsRegister	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/EuropeanUnionClinicalTrialsRegister/NorvascAsAuthorizedMedicinalProduct
EuropeanUnionClinicalTrialsRegister	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/EuropeanUnionClinicalTrialsRegister/PfizerGmbHAsMarketingAuthorizationHolder
EuropeanUnionClinicalTrialsRegister	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/EuropeanUnionClinicalTrialsRegister/PfizerGmbH
EuropeanUnionClinicalTrialsRegister	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/EuropeanUnionClinicalTrialsRegister/NorvascMarketingAuthorizationInGermany

ontology	resources in v0.3.0 but not in v0.2.0 release

ontology	resources in v0.3.0 but not in v0.2.0 release
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/SPOR-DataClassification
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/SPOR-Domain
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/ReferentialsManagementServicesControlledVocabularyTerm
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/SPOR-MarketingStatusClassifier
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/hasSPORShortName
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/hasSPOROtherName
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/hasSPORTermName
SubstancesProductsOrganisationsReferentials	https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/hasSPORTermDescription
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004984
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/230000000000
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/200000026055
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072083
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072074
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004985
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072075
SubstancesProductsOrganisationsReferentials	https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004986
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PolyvinalChlorideCommonName
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PfizerGmbHAsMarketingAuthorizationHolder
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateSimplifiedMolecularInputLineEntry
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PaperboardCommonName
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascIntermediatePackaging
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateComposition
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateSimplifiedMolecularInputLineEntry
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBoxConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBoxAsOuterPackaging
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineSimplifiedMolecularInputLineEntry
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterPackagingMethod
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularFormulaByMoiety
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Cardboard
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PfizerGmbH
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBox
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterAsImmediateContainer
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascComposition
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascAsAuthorizedMedicinalProduct
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineBesylateMolecularFormula
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProduct
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlister
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMCComposition
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/CardboardCommonName
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascMarketingAuthorizationInGermany
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularFormula
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularFormula
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/P015011211
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateComposition
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascAsStartingMaterial
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascBlisterAsStartingMaterial
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackagedMedicinalProductConstituency
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/MarketingAuthorizationNumber-EMEA/H/A-30/1288
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMolecularFormulaByMoiety
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascPackageTablets
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineMesylateMonohydrateMolecularFormulaByMoiety
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/Paperboard
AmlodipineExample	https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/PolyvinylChloride
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/PhysicalPharmaceuticalProduct
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/PhysicalMedicinalProduct
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/PhysicalSubstance
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/StartingMaterialRole
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/AnalyticalMethod
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MedicinalProductCodeSegment
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/MaterialClassifier
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProcessSpecification
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProductComposition
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ContainerConstituent
ISO11615-MedicinalProducts	https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/Analysis