Hlášení Sample Clauses

Hlášení. Zdravotnické zařízení a/nebo Zkoušející podávají pravidelná písemná hlášení Zadavateli a/nebo CRO, včetně závěrečné písemné zprávy po dokončení Studie nebo při předčasném ukončení této Smlouvy. Hlášení bude uvádět výsledky Studie získané podle této Smlouvy způsobem a formátem vzájemně přijatelným pro Strany. Zdravotnické zařízení zodpoví případné dotazy Zadavatele a CRO ohledně stavu Studie. Tento oddíl 4.1 platí i po ukončení platnosti této
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Hlášení. Zdravotnické zařízení a Zkoušející včas předají Zadavateli vyplněné a přesné záznamy subjektů hodnocení („CRF“) a veškeré další záznamy, hlášení a data, jejichž doručení může Zadavatel požadovat podle Protokolu nebo této Smlouvy (souhrnně „Data ze studie“) v souladu s harmonogramy zde uvedenými. Nehledě na jakákoliv delší časová období uvedená v Protokolu musejí být všechny formuláře CRF vyplněny do dvou týdnů po návštěvě studijního subjektu. Veškeré další informace a údaje shromážděné nebo připravené v souvislosti s Protokolem, kromě Dat ze studie, např. zdravotní záznamy, zdrojové pracovní listy, rentgenové snímky, snímky CT, MR, ostatní diagnostické snímky a veškeré další primární datové zdroje, které představují základ dat zaznamenaných na formulářích případu (souhrnně jako „Zdrojové záznamy“), zůstanou ve Zdravotnickém zařízení a budou k dispozici ke kontrole. Navíc Zdravotnické zařízení a Zkoušející souhlasí, a zároveň zajistí, aby i Personál studie souhlasil, že poskytnou veškerá dodatečná data, přístup nebo součinnost přiměřeně požadovanou Zadavatelem ve spojení se Zadavatelovým předáním hodnoceného léku ke schválení nebo povolení.

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