Archivace a audity 12. Recordkeeping and Audits Sample Clauses

Archivace a audity 12. Recordkeeping and Audits. 12.1 Poskytovatel a hlavní zkoušející jsou povinni uchovávat veškeré údaje týkající se klinického hodnocení a provedených služeb a veškeré další záznamy vytvořené v rámci této smlouvy po dobu dvaceti pěti (25) let nebo po jinou dobu sjednanou mezi smluvními stranami, anebo vyžadovanou platnými místními předpisy. 12.1 The Institution and Principal Investigator shall keep complete and systematic data related to the Clinical Trial and the Services performed and any other records generated as a part of this Agreement for twenty five (25) years, or as agreed by the Parties, or as required by applicable local regulation. 12.2 Po uplynutí výše uvedené lhůty a před likvidací takových záznamů je Poskytovatel/hlavní zkoušející povinen vyrozumět GSK, a pokud o to GSK požádá, je povinen takové záznamy místo likvidace předat GSK. 12.2 Upon the expiration of the above time period, prior to disposing of such records the Institution/Principal Investigator shall notify GSK and if GSK requests, shall deliver such records to GSK rather than dispose of them. 12.3 V běžné pracovní době poskytovatele a po vyrozumění přiměřenou dobu předem mohou PPD, GSK či její společnosti ve skupině nebo jimi pověřené osoby provádět audit záznamů, prostor, vybavení, nebo postupů poskytovatele týkajících se povinností poskytovatele na základě této smlouvy. Tyto audity mohou zahrnovat zejména záznamy poskytovatele týkající se klinického hodnocení a provádění služeb, s cílem ověřit dodržování pravidel ze strany poskytovatele.
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Archivace a audity 12. Recordkeeping and Audits. 12.1 Poskytovatel a hlavní zkoušející jsou povinni uchovávat veškeré údaje týkající se klinického hodnocení a provedených služeb a veškeré další záznamy vytvořené v rámci této smlouvy po dobu minimálně patnácti (15) let od data vydání konečné zprávy/souhrnu klinického hodnocení nebo jiné podobné zprávy. GSK bude informovat hlavního zkoušejícího o datu, kdy vyprší požadovaná archivační doba GSK. Po uplynutí požadované archivační doby GSK a jakékoli dodatečného archivačního období požadovaného místními, organizačními, státními, národními a/nebo regulačními pokyny poskytovatel vymaže nebo zničí záznamy klinického hodnocení a to v souladu s postupy poskytovatele pro vymazání anebo zničení záznamů. 12.1 The Institution and Principal Investigator shall keep complete and systematic data related to the Clinical Trial and the Services performed and any other records generated as a part of this Agreement for at least a minimum of fifteen (15) years from the issue date of the Clinical Trial report/summary or equivalent. GSK will inform the Principal Investigator of the date on which the GSK required retention period will expire. After the expiration of the GSK required retention period, and any additional period required by local, organizational, state, national, and/or regulatory guidelines, Institution shall delete or destroy Institution’s Clinical Trial records in accordance with Institution’s records deletion or destruction practices. 12.2 Nebudou-li kdykoli během lhůty pro uchovávání hlavní zkoušející a/nebo poskytovatel schopni plnit povinnosti týkající se uchovávání záznamů uvedené v tomto článku (např. z důvodu odchodu hlavního zkoušejícího do důchodu nebo protože hlavní zkoušející již není zaměstnán u poskytovatele nebo s ním není spojen nebo z důvodu uzavření pracoviště poskytovatele), hlavní zkoušející nebo poskytovatel převedou odpovědnost za uchovávání záznamů na jinou smluvní stranu v rámci poskytovatele nebo na archiv třetích stran mimo pracoviště. Hlavní zkoušející nebo poskytovatel musí písemně informovat CRO a/nebo společnost GSK před takovým předáním, 12.2 If, at any time during the retention period, Principal Investigator and/or Institution are unable to comply with the record retention responsibilities in this Section (e.g., Principal Investigator retirement; Principal Investigator is no longer employed by or associated with Institution; or, Institution site closure), Principal Investigator or Institution shall transfer responsibility for record ...
Sample 1
Archivace a audity 12. Recordkeeping and Audits. 12.1 Poskytovatel a hlavní zkoušející jsou povinni uchovávat veškeré údaje týkající se klinického hodnocení a provedených služeb a veškeré další záznamy vytvořené v rámci této smlouvy po dobu patnácti (15) let vyžadovanou platnými právními předpisy, v případě budoucí změny právní úpravy doby archivace na dvacet pět (25) let, strany sjednávají, že nebude nutné uzavírat dodatek k této smlouvě.. 12.1 The Institution and Principal Investigator shall keep complete and systematic data related to the Clinical Trial and the Services performed and any other records generated as a part of this Agreement for fifteen (15) years as required by applicable legal regulation, in case futer change to applicable regulation to twentyfive (25) years, Parties agree that is will not be necessary to conclude an amendment to this Agreement. 12.2 Po uplynutí výše uvedené lhůty budou veškeré záznamy skartovány v souladu s příslušnými právními předpisy. V případě, že GSK má zájem na další archivaci záznamů, je povinno svůj požadavek uplatnit písemně u poskytovatele nejméně dva měsíce před uplynutím sjednané doby archivace a poskytovatel další archivaci na náklady GSK zajistí, popř. mu dokumentaci vydá. 12.2 Upon the expiration of the above time period, all the records will be destroyed in accordance with applicable legal regulations. In case GSK requires further archiving of the records, GSK is obliged to provide such a request at least 2 months before the agreed archiving period and the Institution will ensure further archiving on GSK expenses or will provide the records to GSK 12.3 V běžné pracovní době poskytovatele a po vyrozumění přiměřenou dobu předem mohou PPD, GSK nebo jimi pověřené osoby provádět audit záznamů, prostor, vybavení, nebo postupů poskytovatele týkajících se povinností poskytovatele na základě této smlouvy. Tyto audity mohou zahrnovat zejména záznamy poskytovatele týkající se klinického hodnocení a provádění služeb, s cílem ověřit dodržování pravidel ze strany poskytovatele.
Sample 1

Related to Archivace a audity 12. Recordkeeping and Audits

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