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Accessible The results summary for this clinical trials registry is at the study rather than patient level so access is unrestricted which does not require authentication or authorisation for viewing (Table X4). The persistence policy for the results summary data and study details metadata is likely to be long term although this is not stated explicitly on the history and policies page.
Interoperable.Even though the metadata for the study description is structured (tabular view or xml), it consists of much free text and almost no identifiers for vocabulary or ontology terms can be found. In this regard, the FAIR interoperability of the clinicaltrial.gov registry could be much improved. Further opportunities to make this registry more FAIR include: 1) JSON Linked Data API instead of plain JSON, 2) Adoption of the openAPI/SmartAPI (https://smart-api.info/guide ) specifications for FAIR services and 3) Convert XML based data schema to an ontology powered schemaConvert data schema (XSD) to an Ontology., Tconvert term lists could be converted to SKOS-CVs, align/cross-map to dominant FAIRsharing terminologies. Adoption of the CDISC vocabulary is also likely to improve this clinical trials registry (Table X4).
Reusable. The use of data is described at https://clinicaltrials.gov/ct2/about-site/terms-conditions which is protected by international copyright outside the USA or some third parties. Guidance is given to study record managers on submission to ClinicalTrials.gov using the Protocol Registration and Results System (PRS). This provides the only mechanism for expression of provenance and maintaining the expected standards, policies and legal obligations for this community. This mechanism would benefit from use of the provenance ontology, PROV and by adoption of the major clinical standard, CDISC.
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FAIR pillars | Simplified FAIR Maturity indicators (MIs) for data and metadata | Formal FAIR MIs | Priority | EU CTR | FAIR Score for study |
Findable | Global Unique Persistent Resolvable identifiers (GUPRI) | F1, F2, F3 | Essential | Identifier for study (how GUPRI?) | 1 |
| Uniform Resource Locator (URL) | F4 | Desirable | URL for study (via query) | 1 |
Accessible | Open standard protocol for identifier resolution to support authentication and authorisation for access to restricted content | A1 | Essential | Unrestricted access to method and results summary (no patient data) |
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| Metadata has a persistence policy for discoverability independent from the associated data | A2 | Desirable | Legal obligation for retention of the registry | 1 |
Interoperable | FAIR vocabularies or ontologies with external links and language for knowledge representation | I1, I2, I3 | Desirable | Free text, no structure (pdf dump) | 0 |
Reusable | Attributes for consent for data usage (licence and owner), provenance (e.g. PROV ontology) and use of relevant clinical standards (e.g. CDISC, OHDSI, FHIR etc.) | R1, R2, R3 | Essential | Study submitter and registry policy and legislation. No provenance or clinical standards. | 1 |
Score key: 2 is fully satisfied, 1 is partial, 0 is not satisfied | Max possible: | 10 | 4 | ||
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Findability: The study identifiers, 2009-012612-41 (=NCT01020123) and 2007-005209-23 (=NCT00633464) are unique and resolvable by machine but the globality and persistence of these identifiers is open to question. These identifiers have been incorporated into the URL (e.g. https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-012612-41 ) which can be found using Google search. This partially satisfies the four FAIR maturity indicators for Findability (F1, F2, F3 and F4) at the study level (Table Y5).
Accessibility: The results summary for this clinical trials registry is at the study rather than patient level so access is unrestricted which does not require authentication or authorisation for viewing (Table Y5). The persistence policy for the results summary data and study details metadata is likely to be long term although this is not stated explicitly. It is notable that CT registry limits user access to a graphical user interface, so there is no programmatic access (i.e. no API) for batch download, unlike http://clinicaltrials.gov .
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