Database: Register of Medical Devices (Czech Republic): Difference between revisions
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'''Sponsor, manager or home institution:''' [[dataOwner::Coordination Centre for Departmental Medical Information Systems (KSRZIS)]]; [[dataOwner::Státní ústav pro kontrolu léčiv (SUKL)]]; [[dataOwner::Ministerstvo zdravotnictví]]. | '''Sponsor, manager or home institution:''' [[dataOwner::Coordination Centre for Departmental Medical Information Systems (KSRZIS)]]; [[dataOwner::Státní ústav pro kontrolu léčiv (SUKL)]]; [[dataOwner::Ministerstvo zdravotnictví]]. | ||
'''Type of information:''' [[databaseStructure::cross-sectional]]. [[hasDataDictionary::Data Dictionary: Register of Medical Devices]]. | '''Type of information:''' [[databaseStructure::cross-sectional]]. [[hasVariable::place of residence]]; [[hasVariable::region]]; [[hasVariable::type of medical activity]]; [[hasVariable::devices]]; [[hasVariable::substance name]]; [[hasVariable::year]]; [[hasVariable::diagnosis]]. [[hasDataDictionary::Data Dictionary: Register of Medical Devices]]. | ||
'''Available type of information:''' [[availableVariable:: | '''Available type of information:''' [[availableVariable::type of medical activity]], [[availableVariable::devices]], [[availableVariable::year]]; [[availableVariable::diagnosis]]. [https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/OpenData Click here to learn more]. | ||
'''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. | ||
Revision as of 17:18, 12 June 2024
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Type of database: registry.
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.
Sponsor, manager or home institution: Coordination Centre for Departmental Medical Information Systems (KSRZIS); Státní ústav pro kontrolu léčiv (SUKL); Ministerstvo zdravotnictví.
Type of information: cross-sectional. place of residence; region; type of medical activity; devices; substance name; year; diagnosis. Data Dictionary: Register of Medical Devices.
Available type of information: type of medical activity, devices, year; diagnosis. Click here to learn more.
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: patient level.
Number of Records: unknown.
Date range: 2015 onwards.
Cancer areas of interest: C00-C97: All cancer types. Click here to learn more.
Data access: partially publicly available. Click here to access. Instructions to request data for restricted content click here to access.
Contact information: Click here to access.