IDMP Ontology Release 0.3.0
IDMP Ontology Release 0.3.0
Ontology Development in Details
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.
Qualitative Comparison To Previous Release
Overview
One new ontology was added: QlairaExample.
No ontology was removed.
The following existing ontologies were changed:
| 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 |
Details
idmp_different_ontologies_in_repository_versions.xlsx
idmp_different_resources_in_ontology_revisions.xlsx
idmp_different_axioms_for_same_subjects.txt
(Tha last file is a json file - to see its contents use a json editor, e.g., https://jsonviewer.stack.hu)
Deprecated Resources
The following resources were deprecated and may be deleted in v0.4.0 release:
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
What's Changed
- single substance has max 1 molecular structure is wrong by @ElisaKendall in #280
- Fix to ISO conformance level test by @mereolog in #282
- IDMP-243 - stereochemisty by @tw-osthus in #279
- IDMP-GitHub-284 - Notes on certain classes for structure, molecular structure, and stereochemistry are needed by @ElisaKendall in #285
- IDMP-398 - Add concept for Marketing Status (SPOR RMS) by @ElisaKendall in #290
- Competency questions split to one query per file by @mereolog in #297
- Add more cleanup instructions for SPOR OMS transformation by @aliariff in #287
- Update SPOR OMS Transformation by @aliariff in #288
- IDMP-385: Update URI pattern by @aliariff in #300
- IDMP-393 & IDMP-408: Add SPOR RMS Transformation by @aliariff in #286
- IDMP 400 - GitHub action for competency questions run as unit tests by @mereolog in #304
- IDMP-405 - Refactor the substance class hierarchy to differentiate actual physical substances from classifiers for substances by @ElisaKendall in #303
- Update config files by @patrycjamia in #298
- All competency questions run as unit tests by @mereolog in #309
- IDMP-416 - Update Amlodipine Example (RDF file) by @ElisaKendall in #311
- IDMP-415 - Update Terlipressin Example for reference strength (RDF) by @ElisaKendall in #313
- IDMP-435 - Create classes for SSG1, SSG2, SSG3, SSG4 by @ElisaKendall in #317
- IDMP viewer config files are updated by @mereolog in #318
- Idmp 462: UC1 CQ Update by @stsilva-osthus in #322
- IDMP-465 - Integrate revised manufactured item and packaging strategy for UC-2 by @ElisaKendall in #321
- IDMP-436: Update SPOR SMS Transformation regarding SSG1 and SSG3 by @aliariff in #327
- IDMP-473 - Integrate the Qlaira Example into our Test Suite by @ElisaKendall in #324
- IDMP-433: Add idmp-sub:hasMoiety by @aliariff in #314
- Idmp 462 Use Case 2 Competency Questions by @stsilva-osthus in #326
- IDMP-479 - Further clean-up is needed to address remaining issues with the Qlaira example by @ElisaKendall in #329
- New cqs added as unit tests by @mereolog in #330
New Contributors
- @tw-osthus made their first contribution in #279
Full Changelog: master_v0.2.0...master_v0.3.0
