Popis Studie. The Institute and the lead Principal Investigator for the Study (the “Principal Investigator") shall perform the Study according to the Protocol, which describes the clinical research activities and tasks to be performed by the Institute under the supervision and direction of the Principal Investigator. The Principal Investigator agrees to use its reasonable efforts, consistent with the Protocol and good clinical practices to enrol only those individual test subjects who meet the inclusion criteria under the Protocol (each hereinafter referred to as a “Subject”). The Study shall be performed in accordance with the applicable laws and permits, specifically including but not limited to required insurance coverage for the Subjects, and, to the extent required, shall be subject to the approval of the Institute’s Ethics Commission, as defined in paragraph 8 below. Zdravotnické zařízení a vedoucí Hlavní zkoušející pro Studii („Hlavní zkoušející“) provede Studii podle Xxxxxxxxx, který popisuje aktivity a úkoly klinického výzkumu, které bude Zdravotnické zařízení provádět pod dohledem a vedením Hlavního zkoušejícího. Hlavní zkoušející souhlasí, že vynaloží přiměřené úsilí, v souladu s Protokolem a správnou klinickou praxí, aby do Studie zařadil pouze ty subjekty, které splňují kritéria pro zařazení podle Protokolu (každý je nadále označován jako „Účastník“). Studie bude provedena v souladu s platnými zákony a povoleními, konkrétně mimo jiné včetně požadovaného pojištění pro Účastníky, a bude v požadovaném rozsahu podléhat schválení etické komise Zdravotnického zařízení, jak je definováno v odstavci 8 níže.
Popis Studie. (a) The Institution will permit the Investigator to conduct the clinical investigation study entitled “A Phase 3 (Pivotal Stage) Study of NBTXR3 Activated by Investigator’s Choice of Radiotherapy Alone or Radiotherapy in Combination with Cetuximab for Platinum-based Chemotherapy- ineligible Elderly Patients with Locally Advanced Head & Neck Squamous Cell Carcinoma” (the “Study”), bearing Clinical Investigation Plan number NANORAY-312, as may be amended from time to time (the “Clinical Investigation Plan”), the provisions of which are incorporated herein by reference, in conformance with: (i) generally accepted standards of good clinical practice (hereinafter the “ICH GCP”), (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study, (iii) the Clinical Investigation Plan, (iv) the FDA Form 1572, as applicable and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the Study. The Institution shall not reassign the conduct of the Study to another investigator without PRA’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein.
