Inspekce, audity a monitorování Klinického hodnocení Sample Clauses

Inspekce, audity a monitorování Klinického hodnocení. A. Inspekce regulačních úřadů. Řešitelské centrum oznámí okamžitě Zadavateli a jeho zástupci telefonicky nebo faxem všechna šetření, korespondenci nebo komunikaci s nebo od FDA nebo jiného státního nebo regulačního úřadu týkající se Klinického hodnocení. Pokud regulační úřad, zejména FDA, požádá o svolení nebo provede inspekci zařízení Řešitelského centra nebo záznamů o výzkumu týkající se Klinického hodnocení, bude Řešitelské centrum spolupracovat se zástupcem(i) regulačního úřadu a umožní tuto inspekci a vynaloží veškeré přiměřené úsilí, aby umožnilo Zadavateli zkontrolovat záznamy před inspekcí a bylo v průběhu takovýchto inspekcí přítomen a k dispozici. Zdravotnické zařízení poskytne bez prodlení a bez dodatečných nákladů pro Zadavatele dostatečný a vhodný prostor, který je považován za potřebný pro Zkoušejícího a/nebo Zadavatele pro takovéto inspekce. V průběhu takovýchto inspekcí bude Zkoušející a příslušný Tým klinického hodnocení k dispozici, aby bylo vyhověno oprávněným požadavkům inspekce a aby byly vysvětleny a probrány záznamy a dokumentace související s Klinickým hodnocením. Řešitelské centrum poskytne Zadavateli nebo jeho zástupcům písemně a organizovaným způsobem kopie všech materiálů, korespondence, prohlášení, formulářů a záznamů, které Řešitelské centrum dostane, získá nebo vytvoří v souvislosti s jakoukoli takovou inspekcí nebo v souvislosti s jakýmkoli šetřením, komunikací nebo korespondencí od FDA nebo od jakýchkoli jiných státních nebo regulačních úřadů. Řešitelské centrum vynaloží přiměřené úsilí, aby oddělilo a nezveřejnilo žádné dokumenty a materiály, které není potřeba v průběhu takovéto inspekce zveřejnit, včetně finančních údajů a informací o cenách. 12.
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