Popis Studie Sample Clauses

Popis Studie. The Institute and the lead Principal Investigator for the Study (the “Principal Investigator") shall perform the Study according to the Protocol, which Zdravotnické zařízení a vedoucí Hlavní zkoušející pro Studii („Hlavní zkoušející“) provede Studii podle Protokolu, který popisuje aktivity a úkoly 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. 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 xx xxxxxx 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.
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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.

Related to Popis Studie

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Trials The Ship shall run the following test and trials:

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Feasibility Study Buyer will, at Buyer's expense and within ____ days from Effective Date ("Feasibility Study Period"), determine whether the Property is suitable, in Buyer's sole and absolute discretion, for ___________________ use. During the Feasibility Study Period, Buyer may conduct a Phase I environmental assessment and any other tests, analyses, surveys and investigations ("Inspections") that Buyer deems necessary to determine to Buyer's satisfaction the Property's engineering, architectural and environmental properties; zoning and zoning restrictions; subdivision statutes; soil and grade; availability of access public roads, water, and other utilities; consistency with local, state and regional growth management plans, availability of permits, government approvals, and licenses; and other inspections that Buyer deems appropriate to determine the Property's suitability for the Buyer's intended use. If the Property must be rezoned, Buyer will obtain the rezoning from the appropriatx xxxernment agencies. Seller will sign all documents Buyer is required to file in connection with development or rezoning approvals. Seller gives Buyer, its agents, contractors and assigns, the right to enter the Property at any time during the Feasibility Study Period for the purpose of conducting inspections; provided, however, that Buyer, its agents, contractors and assigns enter the Property and conduct inspections at their own risk. Buyer will indemnify and hold Seller harmless from xxxxes, damages, costs, claims and expenses of any nature, including attorney's fees, expenses and liability incurred in application for rezoning or related proceedings, and from liability to any person, arising from the conduct of any and all inspections of any work authorized by Buyer. Buyer will not engage in any activity that xxxxx result in a construction lien being filed against the Property without Seller's prior written consent. If this transaction does not close, Buyer will, at Buyer's expense, (1) repair all damages to the Property resulting from the Inspections and return the Property to the condition it was in prior to conduct of the Inspections, and (2) release to Seller all reports and other work generated as a result of the Inspections. Buyer will deliver written notice to Seller prior to the expiration of the Feasibility Study Period of Buyer's determination of whether or not the Properxx xx acceptable. Buyer's failure to comply with this notice requirement will constitute acceptance of the Property as suitable for Buyer's intended use in its "as is" condition. If the Property is unacceptable to Buyer and written notice of this fact is timely delivered to Seller, this Contract will be deemed terminated as of the day after the Feasibility Study period ends and Buyer's deposit(s) will be returned after Escrow Axxxx receives proper authorization form all interested parties.

  • Special Studies Providing planning services, site evaluations, environmental studies, or comparative studies of prospective sites, preparing special surveys, studies, and submissions required under Applicable Law.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

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