Audity a monitorování Sample Clauses

Audity a monitorování. CRO, zadavatel a jejich zástupci mohou provést audit hlavního zkoušejícího a pracovníků studie, monitorovat je anebo se s nimi setkat u poskytovatele a v zařízení, kde probíhá studie, v průběhu běžné pracovní doby a s četností přiměřenou pro audity a návštěvy za účelem monitorování postupu studie a kontroly záznamů, dokumentů, informací, údajů a materiálů ze studie (včetně údajů shromážděných v průběhu provádění studie, jak je definováno v protokolu, a předkládaných CRO anebo zadavateli (dále jen „údaje ze studie“). Poskytovatel poskytuje součinnost a zajišťuje, aby i hlavní zkoušející a pracovníci studie poskytli součinnost CRO, zadavateli a jejich zástupcům při plánování takových návštěv. CRO, the Sponsor, and their Representative(s) shall be entitled to: (a) examine and inspect all the facilities required for the performance of the Study; (b) inspect Source Documents (as defined under ICH Guidelines; and (c) inspect, request correction of, and copy all Study Data (including, without limitation, Case Report Forms, original reports of laboratory tests and examination findings, and all other notes, charts, reports, or memoranda related to the Study Subjects or to the conduct of the Study), which CRO and the Sponsor are authorized to access by the signed informed consent form, and/or the Regulations. The Provider shall cooperate, and shall ensure that the Principal Investigator cooperates, with CRO and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data. CRO, zadavatel a jejich zástupce (zástupci) je oprávněn: (a) provádět kontroly a inspekce všech zařízení potřebných k provádění studie (b) provádět inspekce zdrojových dokumentů, jak jsou uvedeny ve směrnicích ICH, a (c) provádět inspekce, žádat opravy a kopírovat údaje ze studie (zejména formuláře pro záznamy o subjektech hodnocení, originálních zpráv z laboratorních testů a výsledků šetření, jakož i všech ostatních poznámek, grafů nebo zápisů souvisejících se subjekty hodnocení nebo s prováděním studie), k nimž budou mít CRO a zadavatel oprávněný přístup na základě podepsaného informovaného souhlasu anebo předpisů. Poskytovatel spolupracuje a zajišťuje, aby hlavní zkoušející spolupracoval s CRO a se zadavatelem v průběhu auditů a návštěv za účelem monitorování a při hledání řešení všech problémů týkajících se údajů ze studie.
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