Database: Register of Medical Devices (Czech Republic): Difference between revisions

Revision as of 16:45, 6 May 2024

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: Data Dictionary: Register of Medical Devices.

Available type of information: economic activity, devices, year. 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: unknown.

Data access: partially publicly available [1]. Instructions to request data for restricted content [2].

Contact information: information [3].

@@ Line 1: / Line 1: @@
 {{forresearchers}}
 Go back to [[Czech Republic]] page
+'''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:''' [[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.
 '''Type of information:''' [[hasDataDictionary::Data Dictionary: Register of Medical Devices]].
-'''Available type of information:''' [[availableVariable::economic activity]], [[availableVariable::devices]], [[availableVariable::year]]. [https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/OpenData]
+'''Available type of information:''' [[availableVariable::economic activity]], [[availableVariable::devices]], [[availableVariable::year]]. [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.
@@ Line 16: / Line 16: @@
 '''Number of Records:''' [[numberRecords::unknown]].
-'''Date Range:''' [[dataStart::2015]] [[dataEnd::onwards]].
+'''Date range:''' [[dataStart::2015]] [[dataEnd::onwards]].
-'''Cancer Areas of Interest:''' [[hasCancerAreasList::unknown]].
+'''Cancer areas of interest:''' [[hasCancerAreasList::unknown]].
 '''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].