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FAIR implementation is one of the fundamental enablers for secondary reuse of clinical data, thereby realising much greater value from our data assets. . FAIR clinical data and metadata will be findable (discoverable) by both machines and humans, any access restrictions will be determined by open protocol standards and supported by highly expressive FAIR vocabulary or ontology standards, including formats. These attributes of Findability, Accessibility and Interoperability together support Reusability which includes the attributes of data usage, provenance and community standards as illustrated in Figure 10.
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Registries for clinical interventional and observational studies are important resources for supporting the secondary use of clinical data. Examples include Clinical trial registries such as those provided for the FDA by the NIH (https://clinicaltrials.gov ), the EU (https://www.clinicaltrialsregister.eu ) and Cochrane (https://www.cochranelibrary.com/central) which are within the scope of this guide. For each study, they usually include a study description, the study protocol and summary data for the trial results
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ClinicalTrials.gov
The NIH funded registry, http https://clinicaltrials.gov is the largest open clinical trials database which has been available online since the year 2000. In the web-based user interface, Basic text search (e.g. see query results for “Diabetes Mellitus, Type 2”), is provided along with the advanced search that provides additional search facets, e.g. eligibility criteria, locations or start and end date of a study.
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Findable The study identifiers, NCT01020123 and NCT00633464 are global, unique, persistent and resolvable by machine (GUPRI) which has been incorporated into the Uniform Resource Locator (URL: https://clinicaltrials.gov/ct2/show/study/NCT01020123 ) which is discoverable by Google search. This satisfies the four FAIR maturity indicators for Findability (F1, F2, F3 and F4) at the study level (Table X). The same studies can be retrieved as xml which corresponds to the tabular view in html to expose the structured metadata in a machine-readable format.
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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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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 Y). 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 .
Interoperability: The study methods and results data and metadata are only available in an unstructured format as plain text or as pdf. The content is identical to that found in ClinicalTrials.gov for the two example trial records. This means there are almost no identifiers for vocabulary or ontology terms. Clearly, the FAIR interoperability of the EU CTR is a massive opportunity for improvement.
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