Release Notes 0.5.0

Release Notes 0.5.0

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Ontology Development

Summary

Major accomplishments in the 0.5.0 release range from significant improvements in representation of controlled vocabularies, including but not limited to EMA SPOR vocabularies, to extensions in a number of areas related to the ISO 11238 Substances and ISO 11615 Medicinal Products ontologies.

The revised model for controlled vocabularies extends the Object Management Group's (OMG) Commons Ontology Library with the OMG Multiple Vocabulary Facility (MVF) ontologies, designed specifically to support controlled vocabularies, taxonomies, and nomenclature representation based on ISO 1087. The Commons Ontology Library was also updated to incorporate ontologies that have been revised or added in the 1.1 revision of that standard.

Several controlled vocabularies were added in addition to better support for EMA SPOR, including support for MedDRA vocabularies, Common Terminology Criteria for Adverse Events, ISO 5218 vocabulary for the representation of human sexes, and content from the Public Health Information Network. Content related to the US and EU regulatory agencies and repositories was also extended and US-specific content moved to a new North American module rather than in the main ISO Regulatory Agencies ontology, which ultimately will be limited to international bodies and repositories such as the WHO.

Additional content related to ISO 11238 includes complete coverage for nucleic acids and structurally diverse substances, as well as for more basic concepts such as properties of substances that apply to multiple kinds of substances. Updates to the ISO 11615 Medicinal Products ontology include support for therapeutic indications as well as packaging related details. Most examples were extended to cover the new content and the CellCeptExample was added to support additional competency questions.

Deprecated Resources

All deprecated resources, see Release Notes 0.4.0, were removed in preparation for the IDMP-O 1.0 release.

Comparison with the 0.4.0 version of the IDMP Ontology

Quantitative View

12 new ontologies were added:

Ontology Short Name

CellCeptExample

CommonTerminologyCriteriaForAdverseEvents

ISO1087-TerminologyScience*

ISO1087-VocabularyForTermsAndDefinitions*

ISO5218-RepresentationOfHumanSexes

MedicalDictionaryForRegulatoryActivities

MultipleVocabularyFacility*

MVFtoSKOSMapping*

NorthAmericanRegistrationAuthorities

NorthAmericanRegulatoryAgencies

PublicHealthInformationNetwork

RolesAndCompositions*

Ontologies marked with '*' are OMG-related, either Commons Ontology Library v1.1 or Multiple Vocabulary Facility (MVF).  As noted above, the ISO11238-Substances-DeprecatedElements ontology, which was managed independently in order to facilitate elimination, was deleted.

 

The following ontologies were revised and/or extended:

Ontology Short Name

Deleted Resources

New Resources

Modified Resources

AmlodipineExample

5

13

42

ChangeManagement

1

0

0

DatesAndTimes*

0

9

8

Documents*

14

3

11

EUGovernmentEntitiesAndJurisdictions

0

0

2

EuropeanRegistrationAuthorities

0

2

10

EuropeanRegulatoryAgencies

0

0

5

EuropeanUnionClinicalTrialsRegister

0

0

18

GovernmentEntities

0

0

2

ISO11238-RegistrationAuthorities

62

0

4

ISO11238-Substances

3

72

160

ISO11615-MedicinalProducts

9

42

68

ISO21090-HarmonizedDatatypes

0

2

49

Organizations

0

0

5

PartiesAndSituations*

9

1

30

ProductsAndServices

0

0

11

QlairaExample

1

0

48

QuantitiesAndUnits*

3

5

20

RegistrationAuthorities

0

0

5

RegulatoryAgencies

0

0

4

StatisticalMeasures

0

0

6

SubstancesProductsOrganisationsReferentials

19

108

10

TerlipressinExample

0

3

29

Ontologies marked with '*' are OMG-related, modified as part of the Commons Ontology Library v1.1 release.  Note that certain OMG-specific ontologies were simplified, although some of the content, such as the concepts related to regulatory reporting, will come back in a separate ontology in the 1.2 revision of the Commons library. Elements that were eliminated from the Quantities and Units ontology were renamed to reflect the fact that they actually define scalar quantities. An upcoming addition to the library will cover arrays, tensors, and vectors as well as the related tensor and vector quantities, and a reference library of over 700 units will be generated from the new OMG SysML v2 library of quantities and units. We look forward to being able to use that, given that it is OWL DL compliant, which the QUDT ontology is not, and other ontologies for units tend to be incomplete.

Detailed View

resources in 0.4.0 but not 0.5.0 release

ontology

resources in v0.4.0 but not 0.5.0

ontology

resources in v0.4.0 but not 0.5.0

Documents

https://www.omg.org/spec/Commons/Documents/ReportingParty

Documents

https://www.omg.org/spec/Commons/Documents/TechnicalSpecification

Documents

https://www.omg.org/spec/Commons/Documents/Report

Documents

https://www.omg.org/spec/Commons/Documents/isReportedTo

Documents

https://www.omg.org/spec/Commons/Documents/isReportedBy

Documents

https://www.omg.org/spec/Commons/Documents/hasReportDateTime

Documents

https://www.omg.org/spec/Commons/Documents/hasDateOfIssuance

Documents

https://www.omg.org/spec/Commons/Documents/authors

Documents

https://www.omg.org/spec/Commons/Documents/hasReportingPeriod

Documents

https://www.omg.org/spec/Commons/Documents/hasExpirationDate

Documents

https://www.omg.org/spec/Commons/Documents/hasReportDate

Documents

https://www.omg.org/spec/Commons/Documents/hasRecord

Documents

https://www.omg.org/spec/Commons/Documents/hasTerminationDate

Documents

https://www.omg.org/spec/Commons/Documents/isSpecifiedBy

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMC-TherapeuticIndication-AnginaPectoris

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascAsAuthorizedMedicinalProduct

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineEMC-TherapeuticIndication-Hypertension

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/AmlodipineAsReferenceSubstance

AmlodipineExample

https://spec.pistoiaalliance.org/idmp/ontology/EXT/Examples/AmlodipineExample/NorvascIntermediatePackaging

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/Quantity

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/QuantityValueRange

QuantitiesAndUnits

https://www.omg.org/spec/Commons/QuantitiesAndUnits/QuantityValue

QlairaExample

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ExtensionTBD/hasRouteOfAdministration

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/Role

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/Constituency

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/FunctionalRole

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/isRoleIn

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/playsRole

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/isPlayedBy

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/isManifestedIn

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/hasRole

PartiesAndSituations

https://www.omg.org/spec/Commons/PartiesAndSituations/manifests

ISO11238-Substances

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/SimplifiedMolecularInputLineEntry

ISO11238-Substances

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-Substances/hasSimplifiedMolecularInputLineEntrySpecification

ChangeManagement

https://spec.pistoiaalliance.org/idmp/ontology/META/ChangeManagement/Specification

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/MedicalConditionClassifier

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/ProductConstituency

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasIngredientRole

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasMedicalCondition

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasActiveIngredientRole

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasTherapeuticIndicationText

ISO11615-MedicinalProducts

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11615-MedicinalProducts/hasContraindicationText

SubstancesProductsOrganisationsReferentials

https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/ReferentialsManagementServicesControlledVocabularyTerm

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/hasSPORShortName

SubstancesProductsOrganisationsReferentials

https://spec.pistoiaalliance.org/idmp/ontology/ISO/EuropeanJurisdiction/SubstancesProductsOrganisationsReferentials/ReferentialsManagementServicesClassificationScheme

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000000004/terms/100000000014

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004985

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/200000026055

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004984

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/200000004983/terms/200000004986

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/230000000000

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000000004/terms/100000000013

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072074

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000000004/terms/100000000012

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072075

SubstancesProductsOrganisationsReferentials

https://spor.ema.europa.eu/rmswi/#/lists/100000072052/terms/100000072083

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/PlantListOfAcceptedNomenclatureTaxonomySymbolsSymbol

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/NationalCancerInstituteThesaurusCode

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/PlantListOfAcceptedNomenclatureTaxonomyAndSymbolsEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/ChemicalAbstractsServiceChemicalRegistrySystemEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/NationalCenterForBiotechnologyInformationTaxonomyDatabaseEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/UniqueIngredientNumber

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/IntegratedTaxonomicInformationSystemTaxonomicSerialNumber

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/MedicalSubjectHeadingsUniqueIdentifier

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/NationalCancerInstituteThesaurusEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/NationalCenterForBiotechnologyInformationTaxonomyIdentifier

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/MedDRAMedicalConditionIdentifier

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/CASRegistryNumber

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/IntegratedTaxonomicInformationSystemEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/MedicalSubjectHeadingsEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/GlobalSubstanceRegistrationSystemEntry

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/MedicalDictionaryForRegulatoryActivities

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/PesticideProductInformationSystem

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/InventoryOfEffectiveFoodContactSubstanceNotifications

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/RegulatoryContext-ActiveMoietyForFoodAndDrugAdministrationExclusivity

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/PubChem

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/AmericanChemicalSociety

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/NationalLibraryOfMedicine

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/FoodAndDrugAdministrationRegistrationAuthority

ISO11238-RegistrationAuthorities

https://spec.pistoiaalliance.org/idmp/ontology/ISO/ISO11238-RegistrationAuthorities/VeteransHealthAdministration

ISO11238-RegistrationAuthorities