Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to review all CRFs to ensure their accuracy and completeness. Investigator shall provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product. Investigator shall provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Institution in connection with the conduct of the Study and the Investigational Product. Institution agrees to provide prompt advance notice to Sponsor and Quintiles if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and Quintiles. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. Adverse Events The Investigator shall report adverse events and serious adverse events as directed in the Protocol and by applicable laws and regulations. The Investigator shall cooperate with Sponsor in its efforts to follow-up on any adverse events. The Site shall comply with its LEC reporting obligations. Sponsor will promptly report to the Site, the Institution’s LEC, and Quintiles, any finding that could affect the safety of participants or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the Institution’s LEC approval to continue the Study.
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to to review all CRFs to ensure their accuracy and completeness. Investigator shall provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product. Investigator shall provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Institution in connection with the conduct of the Study and the Investigational Product. Institution agrees to provide prompt advance notice to Sponsor and Quintiles if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and Quintiles.
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to to review all CRFs to ensure their accuracy and completeness. Investigator shall provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product. Investigator shall provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Institution in connection with the conduct of the Study and the Investigational Product. Institution agrees to provide prompt advance notice to Sponsor and Quintiles if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and Quintiles. Povinnosti Zkoušejícího Zkoušející je odpovědný za provedení Studie ve Zdravotnickém zařízení. Tato smlouva nepokrývá ujednání mezi Zadavatelem, Quintiles a Zkoušejícím týkající se provádění Studie Zkoušejícím. Tato ujednání, včetně plateb vůči Zkoušejícímu za provádění Studie, jsou podrobně upravena v separátní písemné smlouvě. Konkrétně pak jde zejména ale nejen o povinnost Zkoušejícího zkontrolovat a porozumět informacím obsaženým v Souboru informací pro zkoušejícího či pokynech k přístroji. Quintiles nebo Zadavatel zajistí, že budou opatřena veškerá požadovaná kontrolní schválení od příslušných regulatorních úřadů a EK. Před zahájením Studie je Zkoušející se zavazuje, že před zahájením Studie zajistí, že byly získány veškeré souhlasy a povolení příslušných regulatorních úřadů a EK a že byly zkontrolovány všechny CRF tak, aby byla zajištěna jejich přesnost a úplnost. Zkoušející ...
Duties of Investigator. 1. Investigator is responsible for the conduct of the Study at Institution. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure charakteru a pro edukativní účely, a (ii) pro přípravu publikací v souladu s Článkem 5 “Práva na zveřejnění”. 1.3.5
Duties of Investigator. Investigator is responsible for the 1.4 Povinnosti zkoušejícího Zkoušející je odpovědný za provedení conduct of the Study at Institution. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. studie ve zdravotnickém zařízení. Tato smlouva nepokrývá ujednání mezi zadavatelem, Quintiles a zkoušejícím týkající se provádění studie zkoušejícím. Tato ujednání, včetně plateb vůči zkoušejícímu za provádění studie, jsou podrobně upravena v separátní písemné smlouvě. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to review all CRFs to ensure their accuracy and completeness. Konkrétně pak jde zejména ale nejen o povinnost zkoušejícího zkontrolovat a porozumět informacím obsaženým v souboru informací pro zkoušejícího či v pokynech k přístroji. Quintiles nebo zadavatel zajistí, že budou opatřena veškerá požadovaná kontrolní schválení od příslušných regulatorních úřadů a EK. Zkoušející se zavazuje, že před zahájením studie ověří, že byly získány veškeré souhlasy a povolení příslušných regulatorních úřadů a EK a že byly zkontrolovány všechny formuláře CRF tak, aby byla zajištěna jejich přesnost a úplnost. Investigator shall provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product. Investigator shall provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Institution in connection with the conduct of the Study and the Investigational Product. Zkoušející je povinen poskytnout písemné prohlášení vztahující se k potenciálním zájmům zkoušejícího ekonomické či jiné povahy, či odhalí jiné zájmy, je-li jich, a to v souvislosti s prováděním této studie či ve vztahu k hodnocenému přípravku. Zkoušející je povinen poskytnout písemné prohlášení, jež bude odhalovat závazky zkoušej...
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labeling instructions. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to review all CRFs to ensure their accuracy and completeness. Investigator agrees to provide a written declaration revealing Investigator’s possible economic or other interests, if any, in connection with the conduct of the Study or the Investigational Product. Investigator agrees to provide a written declaration revealing Investigator’s disclosure obligations, if any, with the Institution in connection with the conduct of the Study and the Investigational Product. Site agrees to provide prompt advance notice to Sponsor and Quintiles if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and Quintiles.
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. This Agreement does not cover the arrangements made between Sponsor, Quintiles and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator for performance of the Study, are detailed in a separate written agreement. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure. Quintiles or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to to review all CRFs to ensure their accuracy and completeness. Institution agrees to provide prompt advance notice to Sponsor and Quintiles if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the prior approval of Sponsor and Quintiles.
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution. Without limitation, it is Investigator’s duty to review and understand the information in the Investigator’s Brochure or device labelling instructions, to ensure that all informed consent requirements are met, to ensure that all required reviews and approvals by applicable regulatory authorities and IRBs are obtained, and to review all CRFs to ensure their accuracy and completeness. 1.13
Duties of Investigator. 2.4.1 Institution hereby certifies that Investigator is an employee of Institution. Institution shall ensure that the Investigator performs the Study in a professional and competent manner in accordance with the Protocol and the terms of this Agreement and with the standard of care reasonably expected of investigators by sponsors of clinical studies. This Agreement does not cover the arrangements made between Study Sponsor, IQVIA and Investigator concerning the conduct of the Study by the Investigator. These arrangements, including payments due to the Investigator and Study Staff for performance of the Study, are detailed in a separate written agreement. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the Investigator’s Brochure. IQVIA or Study Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Investigator is responsible prior to commencement of the Study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to review all CRFs to ensure their accuracy and completeness.
Duties of Investigator. Investigator is responsible for the conduct of the Study at Institution and for supervising any individual or party to whom the Investigator delegates Study- related duties and functions in Delegation-Log. In particular, but without limitation, it is the Investigator’s duty to review and understand the information in the investigator’s brochure or device labeling instructions. IQVIA or Sponsor will ensure that all required reviews and approvals by applicable regulatory authorities and ECs are obtained. The Institution acknowledges, that the Investigator is responsible prior to commencement of the study to ensure that all approvals by applicable regulatory authorities and ECs have been obtained and to review all CRFs to ensure their accuracy and completeness. If the Investigator and Institution retain the services of any individual or party to perform Study-related duties and functions, the Institution and Investigator shall ensure this individual, or party is qualified to perform those Study-related duties and functions and shall implement procedures to ensure the integrity of the Study-related duties and functions performed and any data generated. Notwithstanding the foregoing, neither Institution nor Investigator may delegate or assign any obligation under this Agreement without the prior written approval of Sponsor. Institution agrees to provide prompt advance notice to Sponsor and IQVIA if Investigator will be terminating its employment relationship in the Institution or is otherwise no longer able to perform the Study. The appointment of a new Investigator must have the Poskytovatel nebude odebírat a/nebo si ponechávat biologické vzorky navíc k žádnému použití, které není popsáno v příslušném Protokolu.
