Common use of Audit and Monitoring by PSI Clause in Contracts

Audit and Monitoring by PSI. and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Provider during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Provider and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are authorized to access by the signed Informed Consent Form, and/or the Applicable Regulatory Requirements. The Investigator shall cooperate with PSI and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data. odpovědi ke všem materiálům a/nebo informacím předtím, než je Poskytovatel nebo Hlavní zkoušející poskytnou regulačnímu úřadu v souvislosti s inspekcí nebo šetřením.

Audit and Monitoring by PSI. and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Provider Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Provider Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are authorized to access by the signed Informed Consent FormPoskytovatel a Hlavní zkoušející bez zbytečného odkladu oznámí PSI každou regulační kontrolu nebo šetření týkající se Studie, and/or the Applicable Regulatory Requirementskterou provádí státní nebo kterýkoli jiný regulační úřad (včetně SÚKL, EMA a americké FDA) a o níž se dozvědí. The Investigator shall cooperate with PSI, Zadavatel a/nebo jejich zástupci budou mít právo být přítomni u takových kontrol a šetření a/nebo se na nich podílet. PSI and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data. a Zadavatel budou mít právo revidovat, poskytovat a komentovat veškeré odpovědi ke všem materiálům a/nebo informacím předtím, než je Poskytovatel nebo Hlavní zkoušející poskytnou regulačnímu úřadu v souvislosti s inspekcí nebo šetřením.

Audit and Monitoring by PSI. and the Sponsor a) PSI, the Sponsor and their representatives may audit, monitor and/or meet with the Investigator and the Study Personnel at the Provider Institution during normal business hours and with reasonable frequency for audits and visits to monitor the progress of the Study and review Study records, documents, information, data, and materials (including the Study Data). The Provider Institution and the Investigator shall assist PSI, the Sponsor and their representative(s) in scheduling such visits. b) PSI, the Sponsor and their representative(s) shall be entitled to: (i) examine and inspect the facilities required for the performance of the Study; (ii) inspect source documents; and (iii) 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 PSI and the Sponsor are authorized to access by the signed Informed Consent FormZdravotnícke zariadenie musí okamžite informovať zadávateľa a PSI o všetkých inšpekciách alebo vyšetrovaniach zo strany akéhokoľvek štátneho, and/or the Applicable Regulatory Requirementsvládneho alebo právneho orgánu (vrátane, okrem iného, EMA a americkej FDA), ktoré súvisia so skúšaním a o ktorých sa dozvedia. The Investigator shall cooperate with PSI and the Sponsor during audits and monitoring visits and in the resolution of any questions regarding the Study Data. odpovědi ke všem materiálům PSI, zadávateľ a/nebo informacím předtímalebo ich zástupcovia majú právo byť prítomní a/alebo zúčastniť sa na takejto inšpekcii alebo na vyšetrovaní. Predtým, než je Poskytovatel nebo Hlavní zkoušející poskytnou regulačnímu úřadu ako zdravotnícke zariadenie alebo skúšajúci poskytnú orgánu v souvislosti súvislosti s inspekcí nebo šetřeníminšpekciou alebo vyšetrovaním akékoľvek materiály alebo informácie, má PSI a zadávateľ právo na posúdenie, poskytnutie a/alebo komentáre k týmto materiálom a/alebo informáciám.