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Úroveň certifikace: bronzová úroveň 22 October 2015 Co to v praxi znamená: Datová sada splňuje základní požadavky na otevřená data.
#DDOD Use Case: Historical Structured Product Labels for FDA-Approved Drugs
Shrnutí
- Co poskytovatel nabízí?
- a one-off release of a set of related datasets
- Databázová licence
- Nevztahuje se
- Licence na obsah
- Creative Commons CCZero
- Způsob ověření
- ověřený automaticky
- Datum vydání
- 28 August 2015
- Datum poslední změny
- 30 September 2015
- Vydavatel
- U.S. Department of Health & Human Services
- Klíčová slova
- cder, ddod-use-case, drug-labeling, fda, user-request
- Identifier
- ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs
- Landing Page
- http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs
- Maintainers
- Portnoy, David HealthData@hhs.gov
- Language
- en
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Popis
SUMMARY DDOD use case to request access historical label revisions of FDA-approved drugs. WHAT IS A USE CASE? A “Use Case” is a request that was made by the user community because there were no available datasets that met their particular needs. If this use case is similar to your needs, we ask that you add your own requirements to the specifications section. The concept of a use case falls within the Demand-Driven Open Data (DDOD) program and gives you a formalized way to identify what data you need. It’s for anyone in industry, research, media, nonprofits or other government agencies. Each request becomes a DDOD use case, so that it can be prioritized and worked on. Use Cases also provide a wealth of insights about existing alternative datasets and tips for interpreting and manipulating data for specific purposes. PURPOSE Drug manufacturers and distributions submit documentation about their products to FDA in Structured Product Labeling (SPL) that is available via openFDA. However, the approved labeling is a "living document" that is updated over time to reflect increased knowledge about the safety and effectiveness of the drug. The real-time nature of the labeling information makes it difficult to track the historical changes to a product's label and indications. VALUE The historical context of a product's label and indications is important in understanding how and why product labeling changes and in evaluating pharmaceutical market access. USE CASE SPECIFICATIONS & SOLUTION Information about this use cases is maintained in a wiki: http://hhs.ddod.us/wiki/Use_Case_25:_History_for_structured_product_labels It serves as a knowledge base. USE CASE DISCUSSION FORUM All communications between Data Users, DDOD Administrators and Data Owners are logged as discussions within GitHub issues: https://github.com/demand-driven-open-data/ddod-intake/issues/25 It aims to provide complete transparency into the process and ensure the same message gets to all participants. CASE STATUS Closed via DailyMed, which has XML files of historical SPLs
Obecné informace
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Dokumentace
http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know
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Poskytovatel
U.S. Department of Health & Human Services Do you think this data is incorrect? Let us know
Právní informace
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Právní prohlášení
http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know
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Under which licence can people outside the US reuse this data?
Creative Commons CCZero Do you think this data is incorrect? Let us know
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Obsah chráněný autorským právem
yes, and the rights are all held by the same person or organisation Do you think this data is incorrect? Let us know
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Licence obsahu
Creative Commons CCZero Do you think this data is incorrect? Let us know
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Strojově čitelná data právního prohlášení
licence k datům Do you think this data is incorrect? Let us know
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Ochrana soukromí
nehraje roli, data se netýkají fyzických osob Do you think this data is incorrect? Let us know
Praktické informace
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Relevantní datové katalogy
http://catalog.data.gov/organization/hhs-gov Do you think this data is incorrect? Let us know
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Zastarávání
data časem zastarají, ale mají časové razítko Do you think this data is incorrect? Let us know
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Zálohování dat
data jsou zálohována offsite Do you think this data is incorrect? Let us know
Technické informace
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Strojová čitelnost
strojově čitelné Do you think this data is incorrect? Let us know
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Formát dat
standardizovaný, otevřený Do you think this data is incorrect? Let us know
Sociální informace
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Strojově čitelná metadata
název Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
popis Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
hlavní URL Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
URL dokumentace Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
poskytovatel Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
klíčová slova Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
distribuce Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
datum vydání Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
datum poslední změny Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
související časové období Do you think this data is incorrect? Let us know
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Strojově čitelná metadata
jazyk Do you think this data is incorrect? Let us know
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Strojově čitelná metadata k distribucím
datum vydání Do you think this data is incorrect? Let us know
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Strojově čitelná metadata k distribucím
URL pro přístup k datům Do you think this data is incorrect? Let us know
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Strojově čitelná metadata k distribucím
URL datové sady Do you think this data is incorrect? Let us know
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Strojově čitelná metadata k distribucím
typ média Do you think this data is incorrect? Let us know
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Kontakty
http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know
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Zpětná vazba k publikovaným datovým sadám
http://www.data.gov/issue/?media_url=http://catalog.data.gov/dataset/ddod-use-case-historical-structured-product-labels-for-fda-approved-drugs Do you think this data is incorrect? Let us know