Reports and Case Report Forms Záznamy subjektu hodnocení Sample Clauses

Reports and Case Report Forms Záznamy subjektu hodnocení. 5.2.1 The Institution shall ensure that the Investigator or his/her designee shall prepare and maintain accurately complete records, accounts, notes, reports and data of the Study, including legibly and accurately complete Case Report Forms, provided by the Sponsor or ICON and shall submit them within forty eight (48) Hours of obtaining the data. The Institution shall ensure that the Investigator is present and shall give these forms and make available any source documents related to the Study, to representatives of Sponsor or Zdravotnické zařízení zajistí, že zkoušející xxxx xxx zmocněná osoba vypracují a budou uchovávat přesně vyplněné kompletní záznamy, účetní výkazy, poznámky, zprávy a údaje klinického hodnocení v čitelné podobě a přesně vyplní Záznamy subjektu hodnocení, které mu/jí Zadavatel nebo ICON poskytne, a tyto záznamy do 48 hodin od okamžiku zjištění dat vyplněné odešle. Zdravotnické zařízení zajistí, že zkoušející na základě žádosti tyto záznamy bez prodlení předá zástupcům Zadavatele nebo společnosti ICON a zpřístupní xxx jakékoliv ICON at periodic monitoring visits or otherwise promptly upon request. Such ICON monitoring visits and data collection shall be conducted approximately every 8 weeks. zdrojové dokumenty související s Klinickým hodnocením při pravidelných kontrolních návštěvách nebo jinak. Tyto kontrolní návštěvy společnosti ICON a odběr údajů budou uskutečňovány přibližně jednou za 8 týdnů. Zdravotnické zařízení zajistí, že zkoušející bude během kontrolních návštěv osobně přítomen.
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