Unavailability of the Investigator Nedostupnost Zkoušejícího Sample Clauses

Unavailability of the Investigator Nedostupnost Zkoušejícího. 6.2.1 The Investigator is essential to the Study being conducted under this Agreement. Whereas the Investigator shall oversee the entire Study, in his or her temporary absence the Institution/Investigator shall designate these responsibilities to a qualified sub- investigator, who shall be identified in writing. When the Investigator’s absence is anticipated to exceed seven (7) days, ICON shall be notified in writing of the designated sub- investigator who shall assume the Study responsibilities. ICON on its own behalf or that of the Sponsor may approve or reject any proposed sub-investigator. Such approval shall not be unreasonably withheld. Should a permanent substitution for the Investigator be required, the Institution shall notify ICON in writing, in accordance with Section 15.3. The Institution may not permanently substitute other investigators, or make substantial changes in the level of effort asserted by the Investigator, without the prior written approval of ICON in the absence of which ICON shall be entitled to invoke the provisions of Section 11.3.1.6 below. Zkoušející je pro provedení studie dle této smlouvy zcela nezbytný. Jelikož bude zkoušející dohlížet nad celým průběhem studie, musí v jeho nepřítomnosti zdravotnické zařízení / zkoušející přidělit tyto povinnosti způsobilému spoluzkoušejícímu, který bude určen písemně. Má-li předpokládaná absence zkoušejícího překročit sedm (7) dnů, musí být společnost ICON písemně informována o jmenovaném spoluzkoušejícím, který převezme povinnosti vyplývající ze studie. Společnost ICON může svým vlastním jménem nebo jménem zadavatele jakéhokoli navrhovaného spoluzkoušejícího schválit nebo odmítnout. Takové schválení nebude bezdůvodně odpíráno. Bude-li nutné zkoušejícího nahradit trvale, zdravotnické zařízení společnost ICON písemně uvědomí v souladu s článkem 15.3. Zdravotnické zařízení nesmí trvale nahradit jiné zkoušející ani provádět podstatné změny v úrovni činnosti zkoušejícího bez předchozího písemného souhlasu společnosti ICON. V případě neexistence takového souhlasu má společnost ICON právo uplatnit ustanovení článku 11.3.1.6 níže. 7 INVESTIGATIONAL PRODUCT HODNOCENÝ PŘÍPRAVEK
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Unavailability of the Investigator Nedostupnost Zkoušejícího. 6.2.1 The Investigator is essential to the Study being conducted under this Agreement. Whereas the Investigator shall oversee the entire Study, in his or her temporary Přítomnost Zkoušejícího je zásadní pro provádění Klinického hodnocení dle této Smlouvy. Vzhledem k tomu, že Zkoušející bude dohlížet na prnběh absence the Institution/Investigator shall designate these responsibilities to a qualified sub-investigator, who shall be identified in writing. When the Investigator’s absence is anticipated to exceed seven (7) days, CRO shall be notified in writing of the designated sub-investigator who shall assume the Study responsibilities. CRO and/or Sponsor may approve or reject any proposed sub-investigator. Such approval shall not be unreasonably withheld. Should a permanent substitution for the Investigator be required, the Institution shall notify CRO and Sponsor in writing, in accordance with Section 15.3. The Institution may not permanently substitute other investigators, or make substantial changes in the level of effort asserted by the Investigator, without the prior written approval of CRO in the absence of which CRO shall be entitled to invoke the provisions of Section 11.3.1.6 below.
Sample 1

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