Database: Register of Medical Devices (Czech Republic): Difference between revisions
(Created page with "{{#subobject:Register of Medical Devices |dct:title=Register of Medical Devices |datatype=registry }} '''Sponsor, manager or home institution:''' Coordination Centre for Departmental Medical Information Systems (KSRZIS); Státní ústav pro kontrolu léčiv (SUKL); Ministerstvo zdravotnictví. '''Primary purpose:''' To collect data on registered persons handling medical devices, information on notified medical devices, on certificates issued by notified persons base...") |
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'''Sponsor, manager or home institution:''' Coordination Centre for Departmental Medical Information Systems (KSRZIS); Státní ústav pro kontrolu léčiv | '''Sponsor, manager or home institution:''' [[dataOwner::Coordination Centre for Departmental Medical Information Systems (KSRZIS)]]; [[dataOwner::Státní ústav pro kontrolu léčiv (SUKL)]]; [[dataOwner::Ministerstvo zdravotnictví]]. | ||
'''Primary purpose:''' To collect data on registered persons handling medical devices, information on notified medical devices, on certificates issued by notified persons based in the Czech Republic, about adverse events and about safety corrective measures and information about clinical trials. | '''Primary purpose:''' To collect data on registered persons handling medical devices, information on notified medical devices, on certificates issued by notified persons based in the Czech Republic, about adverse events and about safety corrective measures and information about clinical trials. | ||
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'''Source of Information:''' Authorized representatives, importers, distributors, persons engaged in servicing medical devices, sponsors of clinical trials, and Notified Bodies for medical devices who notify the Ministry of Health of their purchases and activities. | '''Source of Information:''' Authorized representatives, importers, distributors, persons engaged in servicing medical devices, sponsors of clinical trials, and Notified Bodies for medical devices who notify the Ministry of Health of their purchases and activities. | ||
'''Data level:''' | '''Data level:''' [[dataLevel::individual level]]. | ||
'''Number of Records:''' | '''Number of Records:''' [[numberRecords::unknown]]. | ||
'''Date Range:''' 2015 onwards. | '''Date Range:''' [[dataStart::2015]] [[dataEnd::onwards]]. | ||
'''Cancer Areas of Interest:''' | '''Cancer Areas of Interest:''' [[hasCancerAreasList::unknown]]. | ||
'''Data access:''' | '''Data access:''' [[dataAvailability::partially publicly available]] [https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/]. Instructions to request data for restricted content [[hasDataAccessInstructions::[http://eregpublic.ksrzis.cz/cms/web/Stranky/RZPRO-anglick%C3%A1-verze-%C3%BAvodn%C3%AD-str%C3%A1nky.aspx]]]. | ||
'''Contact information:''' information [https://www.uzis.cz/index.php?pg=registry-sber-dat--ostatni-rezortni-registry--registr-zdravotnickych-prostredku]. | '''Contact information:''' information [https://www.uzis.cz/index.php?pg=registry-sber-dat--ostatni-rezortni-registry--registr-zdravotnickych-prostredku]. | ||
Revision as of 03:29, 26 November 2023
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Sponsor, manager or home institution: Coordination Centre for Departmental Medical Information Systems (KSRZIS); Státní ústav pro kontrolu léčiv (SUKL); Ministerstvo zdravotnictví.
Primary purpose: To collect data on registered persons handling medical devices, information on notified medical devices, on certificates issued by notified persons based in the Czech Republic, about adverse events and about safety corrective measures and information about clinical trials.
Type of information: The data set includes information about registered individuals in RZPRO and the medical devices they have notified, containing details about the person, the associated activity, and the validity of the device.
Available type of information: Data Dictionary: Register of Medical Devices.
Source of Information: Authorized representatives, importers, distributors, persons engaged in servicing medical devices, sponsors of clinical trials, and Notified Bodies for medical devices who notify the Ministry of Health of their purchases and activities.
Data level: individual level.
Number of Records: unknown.
Date Range: 2015 onwards.
Cancer Areas of Interest: unknown.
Data access: partially publicly available [1]. Instructions to request data for restricted content [2].
Contact information: information [3].
