Conduct of Study; Suspension Sample Clauses

Conduct of Study; Suspension. Institution agrees to administer The Institution may not be changed without Xxxxxxx’x prior written consent. The Study shall commence as soon as possible following receipt of EC and local Regulatory Authority written approval, or as otherwise agreed upon in writing with Sponsor. Sponsor plans to conduct the Study at multiple sites, including at the Institution. Sponsor or CRO may suspend the entire Study (or a portion of the Study conducted by Investigator at Institution) at any time for any reason. Institution may suspend the portion of the Study conducted by Institution and Investigator at Institution, if, using reasonable and good medical judgment consistent with generally accepted standards of care, Investigator or Institution reasonably determine it is appropriate to do so to protect the health or safety of the subject participating in the Study and immediately provide written notice thereof to Sponsor and CRO. The suspension of the Study by Sponsor, CRO, Institution or Investigator in accordance with this Section 1.3 shall not be deemed a material breach of this Agreement. The Institution shall notify the Sponsor promptly if the Investigator is unable or unwilling to continue the Study or if the Investigator’s affiliation with the Institution ceases, whereupon the Sponsor will have a right of approval with respect to the designation of a new investigator. 1.3 Provádění Studie; pozastavení. Zdravotnické zařízení se zavazuje, že bude tuto Studii spravovat, Změnu Zdravotnického zařízení nelze provést bez předchozího písemného souhlasu Zadavatele. Studie bude zahájena co nejdříve po získání písemného kladného stanoviska EK a schválení místním kontrolním úřadem, pokud se Zadavatelem nebude písemně dohodnuto něco jiného. Zadavatel plánuje provádět Studii v několika centrech, včetně Zdravotnického zařízení. Zadavatel nebo CRO mohou celou Studii (nebo její část prováděnou Zkoušejícím ve Zdravotnickém zařízení) kdykoli a z jakéhokoli důvodu pozastavit. Zdravotnické zařízení může část Studie prováděnou Zdravotnickým zařízením a Zkoušejícím ve Zdravotnickém zařízení pozastavit, pokud za použití přiměřeného a řádného lékařského úsudku v souladu s obecně uznávanými standardy péče dospějí k závěru, že je to vhodné, aby tak byl ochráněn zdravotní stav nebo bezpečnost subjektů účastnících se Studie, a budou o tom neprodleně písemně informovat Zadavatele a CRO. Pozastavení Studie Zadavatelem, CRO, Zdravotnickým zařízením nebo Zkoušejícím v souladu s tímto bodem 1.3 n...
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Conduct of Study; Suspension. Institution agrees and ensures that Investigator agrees to administer this Study solely at the Institution and at other subcontracted locations only after Sponsor’s approval (if applicable). The Institution may not be changed without Sponsor’s prior written consent. The Study shall commence as soon as possible following receipt of RA and ECs written approval, or as otherwise agreed upon in writing with Sponsor. Sponsor plans to conduct the Study at multiple sites, including the Institution. Sponsor or CRO may suspend the entire Study (or the portion of the Study conducted by Institution) at any time for any reason. Institution may suspend the portion of the Study conducted by Institution, if, using good medical judgment, Institution or assigned Investigator determine it is appropriate to do so for the medical benefit of the subject participating in the Study. The suspension of the Study by Xxxxxxx, CRO, or Institution in accordance with this Section 1.4 shall not be deemed a material breach of this Agreement.
Conduct of Study; Suspension. Institution agrees to administer, and Investigator agrees to conduct, this Study solely at the Institution. The Institution may not be changed without Sponsor’s prior written consent. The Study shall commence as soon as possible following receipt of EC and local Regulatory Authority written approval, or as otherwise agreed upon in writing with Sponsor. Sponsor plans to conduct the Study at multiple sites, including at the Institution. Sponsor or CRO may suspend the entire Study (or a portion of the 1.3
Conduct of Study; Suspension. Provider agrees to administer, and Investigator agrees to conduct, this Study solely at the Provider. The Provider may not be changed without GWWO’s prior written consent. The 1.3
Conduct of Study; Suspension. Institution agrees to administer, and Investigator agrees to conduct, this Study solely at the Institution. The Institution may not be changed without Sponsor’s prior written consent. The Study shall commence as soon as possible following receipt of EC written společně jen „Spoluzkoušející lékaři “ a jednotlivě jako „Spoluzkoušející lékař“) a všechny další osoby, které se podílejí na provádění klinického hodnocení ve Zdravotnickém zařízení (zařízeních) nebo jsou součástí týmu Zkoušejícího lékaře, včetně všech vyučujících, personálu, zaměstnanců, subdodavatelů nebo studentů schválených Zadavatelem nebo CRO (xxxx „Člen týmu klinického hodnocení”). Každý Spoluzkoušející lékař musí být instruován tak, aby se řídil pokyny Zkoušejícího lékaře a přísně dodržoval protokol. Každý člen týmu klinického hodnocení bude poučen o xxx, že musí přísně dodržovat pokyny Zkoušejícího lékaře nebo Dílčího zkoušejícího lékaře, podle situace, a přísně dodržovat Protokol. Zkoušející lékař a každý Spoluzkoušející lékař bude zaměstnancem Zdravotnického zařízení. Zdravotnické zařízení ani Zkoušející lékař nesmějí být stranou žádné dohody, ani nesmí mít žádné závazky, které by byly v rozporu s ustanoveními této Smlouvy a během klinického hodnocení nesmí uzavřít žádnou dohodu, která by byla v rozporu s touto Smlouvou. Zkoušející lékař nesmí být odvolán nebo nahrazen bez předchozího písemného souhlasu Zadavatele. Pokud Zkoušející lékař xxxx xxxxxxx nebo ochoten pokračovat v této funkci nebo ukončí svůj pracovní poměr ve Zdravotnickém zařízení, pak Zdravotnické zařízení neprodleně písemně informuje CRO, konzultuje se Zadavatelem a CRO jmenování náhradního Zkoušejícího lékaře a vynaloží veškeré úsilí k nalezení náhradního Zkoušejícího lékaře. Zadavatel se může dle vlastního uvážení rozhodnout, že navrhovaného náhradního Zkoušejícího lékaře nepřijme, v takovém případě má Zadavatel právo ukončit Smlouvu s účinností od okamžiku, kdy Zdravotnické zařízení obdrží písemné oznámení Zadavatele o ukončení smlouvy. V případě, že Zadavatel a CRO přijmou náhradního Zkoušejícího lékaře, zajistí Zdravotnické zařízení souhlas náhradního Zkoušejícího lékaře se všemi podmínkami platnými pro Zkoušejícího lékaře v souladu s touto Smlouvou.
Conduct of Study; Suspension. Institution agrees to administer and conduct this Study solely at the Institution. The Institution may not be changed without Sponsor’s prior written consent. The Study shall commence as soon as possible following receipt of EC's and all necessary local Regulatory Authority written approvals, or as otherwise agreed upon in writing with Sponsor, however in this event not before all necessary approvals have been optained. Sponsor plans to conduct the Study at multiple sites, including at the Institution. Sponsor or CRO may suspend the entire Study (or a portion of the Study conducted by Institution at any time for any reason. Institution may suspend the portion of the Study conducted by Institution, if, using reasonable and good medical judgment consistent with generally accepted standards of care, Institution reasonably determines it is appropriate to do so to protect the health or safety of the subjects participating in the Study ("Study Subject") and immediately provides written notice thereof to Sponsor and CRO. The suspension of the Study by Sponsor, CRO or Institution in accordance with this Section 1.4 of the Agreement shall not be deemed a material breach of this Agreement. 1.4

Related to Conduct of Study; Suspension

  • Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.

  • Inspection and Approval All works embracing more than one process shall be subject to examination and approval at each stage thereof and the Contractor shall given due notice to the Engineer-in-Charge or his authorized representative when each stage is ready. In default of such notice the Engineer-in- Charge shall be entitled to appraise the quality and extent thereof.

  • Application and Approval (a) 1. An employee shall make written application to her Employer on or before January 31st of the year in which the deferment is to commence, requesting permission to participate in the Plan.

  • Effect of Suspension You must pay all applicable fees incurred before and during any suspension. You will not be entitled to any service credits under an applicable Service Level Agreement or Service Level Objective during any suspension.

  • Conduct of Hearings Hearings shall be conducted in accordance with the procedures contained in Government Code Section 11513. Hearing sessions shall be private with attendance limited to the panel, the parties’ representatives and witnesses as scheduled. In cases involving below-standard evaluations or disciplinary action, the District shall proceed first in providing evidence.

  • 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.

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