Trial Conduct. Institution and Principal Investigator will conduct the Trial in accordance with the Protocol, Sponsor’s or its designee’s written instructions and Applicable Law. 4.
Trial Conduct. Institution and Investigator will conduct the Trial at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Institution and Investigator under this Agreement; (iii) all applicable laws, in particular Act no. 378/2007 Coll., Act on Pharmaceuticals, Act no. 372/2011 Coll. Act on medical services and Act no. 101/2000 Coll., Act on personal data protection, rules, regulations and guidance, including, without limitation, the applicable directives of the European Union, including those related to the conduct of human clinical trials and the protection of personal data (95/46/EEC) and all applicable anti-corruption, anti-kickback, and fraud and abuse statutes; (iv) good clinical practice requirements as may be published by the International Conference on Harmonization Harmonized Tripartite Guidelines for Good Clinical Practice (“ICH-GCP”), including, without limitation, GCP (ICH-E6), clinical safety data management (ICH-E2A) and general considerations for clinical trials (ICH-E8); (v) generally accepted treatment standards of the medical profession, and (vi) all other applicable laws and regulations of the country in which the Trial is conducted. Institution shall be solely responsible for any liabilities resulting from any failure by Institution to perform in accordance with the foregoing requirements. Neither Institution nor Investigator will deviate from the Protocol without the advance written consent of Gilead, unless in the good medical judgment of Investigator, a deviation is necessary to protect the safety of the Trial subjects due to emergent or urgent medical conditions, in which case Investigator or Institution shall notify Gilead orally of such deviation and justification for it within twenty-four (24) hours after its occurrence and provide a written report to Gilead within five (5) business days after the occurrence of such deviation. 1.2 P rovádění studie Instituce bude provádět Studii ve Zkoušejícím centru studie v přísném souladu s (i) Protokolem; (ii) se závazky Institucee dle této Smlouvy; (iii) ustanoveními všech příslušných zákonů, zejména zákona č. 378/2007 Sb., Zákon o léčivech, zákona č. 372/2011 Sb. Zákon o zdravotních službách a zákona č. 101/2000 Sb. Zákon o ochraně osobních údajů, pravidly, nařízeními a směrnicemi, včetně, bez omezení, platných směrnic Evropské Unie, včetně těch, které se vztahují na provádění humánních klinických studií a ochraně osobních údajů (95/46/EHS) a veškerých platných protikorupčn...
Trial Conduct. Institution and Investigator will conduct the Trial at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Institution and Investigator under this Agreement; (iii) all applicable laws, rules, regulations and guidance, including, without limitation, the applicable directives of the European Union, including those related to the conduct of human clinical trials and the protection of personal data (95/46/EEC) and all applicable anti-corruption, anti-kickback, and fraud and abuse statutes; (iv) good clinical practice requirements as may be published by the International Conference on Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice (“ICH- GCP”), including, without limitation, GCP (ICH- E6), clinical safety data management (ICH-E2A) and general considerations for clinical trials (ICH- E8); (v) generally accepted treatment standards of the medical profession, and (vi) all other applicable laws and regulations of the country in which the Trial is conducted. Institution shall be solely responsible for any liabilities resulting from any failure by Institution to perform in accordance with the foregoing requirements. Neither Institution nor Investigator will deviate from the Protocol without the advance written consent of Gilead, unless in the good medical judgment of Investigator, a deviation is necessary to protect the safety of the Trial subjects due to emergent or urgent medical conditions, in which case Investigator or Institution shall notify Gilead orally of such deviation and the justification for it within twenty-four (24) hours materiály nebo služby související se Studií, které dodala nebo zaplatila společnost Gilead. (iv) Pokud společnost Gilead požaduje, aby se Zkoušející a Personál Studie (definovaný níže) zúčastnil setkání zkoušejících pro Studii, společnost Gilead zařídí a uhradí přímé náklady na cestování, ubytování a stravu v souvislosti s účastí. Takto proplacené výdaje mohou být veřejně vykazatelné. Nebude vyplacena žádná odměna v souvislosti s účastí na setkání zkoušejících. 1.2
Trial Conduct. Institution agrees
Trial Conduct. 5 Provádění Klinického hodnocení Institution and PI shall conduct the Trial in accordance with the Protocol, Sponsor’s or its designee’s/third party vendor’s (including the CRO’s) written instructions, and Applicable Law. Institution shall provide appropriate resources and facilities to enable PI to conduct the Trial in a timely and professional manner and in accordance with the terms of this Agreement. Sponsor has designated CRO as the Trial monitor, and Institution and PI hereby are authorized to communicate directly with CRO with respect to Trial monitoring efforts. Notwithstanding the foregoing, any notice required to be given to Sponsor under this Agreement will not be deemed delivered if such notice is given solely to CRO. Instituce a HZ budou provádět Klinické hodnocení v souladu s Protokolem, písemnými pokyny Zadavatele nebo jím pověřeného/externího dodavatele (včetně CRO) a Platnými právními předpisy. Instituce a HZ zajistí vhodné zdroje, prostory a zařízení, které umožní provádět Klinické hodnocení profesionálně, včas a v souladu s podmínkami této Smlouvy. Zadavatel jmenoval CRO Monitorem Klinického hodnocení a Instituce a HZ jsou tímto oprávněni komunikovat přímo s CRO, pokud jde o záležitosti monitorování Klinického hodnocení. Bez ohledu na výše uvedené nebude žádné oznámení, které má být podle této Smlouvy předloženo Zadavateli, považováno za doručené, pokud bude doručeno pouze CRO.
Trial Conduct. Institution will conduct the Trial in accordance with the Protocol, Sponsor’s or its designee’s written instructions and 4. Výkon skúšania. Inštitúcia bude vykonávať Skúšanie v súlade s Protokolom, písomnými pokynmi Sponzora alebo ním určenej osoby a Applicable Law. Príslušnými právnymi predpismi.
Trial Conduct. Institution and Investigator will conduct the Trial at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Institution and Investigator under this Agreement; (iii) all applicable laws, rules, regulations and guidance, including, without limitation, the applicable directives and regulations of the European Union, including those related to the conduct of human clinical trials and the protection of personal data and all applicable anti-corruption, anti-kickback, and fraud and abuse statutes; (iv) good clinical practice requirements as may be published by the International Conference on Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice (“ICH-GCP”), including, without limitation, GCP (ICH-E6), clinical safety data management (ICH-E2A) and general considerations for clinical trials (ICH-E8);
Trial Conduct. Institution will conduct the Trial in accordance with the Protocol, Sponsor’s and/or INC Research’s written instructions and Applicable Law. Institution and Principal Investigator are entitled to refuse the instructions of the Sponsor or INC Research and will not be bound by such instructions if (i) such instructions are in conflict with the law, Protocol, approval of State Institute for Drug Control or approval of competent ethics committees, good clinical practice, or (ii) it can be reasonably expected that fulfilment of such instructions would disproportionately increase health risks for the Trial Subjects. INC Research hereby declares that it has handed over to the Principal Investigator/Institution all information (documents) necessary under applicable laws for due performance of the Trial and that such information (including Protocol) are complete and correct for the purposes of the Trial performance. INC Research hereby undertakes to inform the Institution immediately about the termination of the Trial (premature or expected in due course). INC Research shall be responsible to inform the Institution immediately if SÚKL suspend or prohibit the performance of the Trial and if the approval given by 4. Provádění hodnocení. Instituce bude hodnocení provádět v souladu s protokolem, písemnými pokyny zadavatele anebo společnosti INC Research a platnými zákony. Instituce a Hlavní zkoušející jsou oprávněni odmítnout plnění pokynů zadavatele nebo společnosti INC Research a nebudou vázáni povinností tyto pokyny plnit, pokud (i) jsou tyto v rozporu s právními předpisy, Protokolem, povolením Státního ústavu pro kontrolu léčiv nebo souhlasným stanoviskem příslušných etických komisí, správnou klinickou praxí, nebo (ii) lze odůvodněně předpokládat, že jejich plnění by představovalo neúměrné zvýšení zdravotního rizika pro subjekty hodnocení. INC Research prohlašuje, že předal Hlavnímu zkoušejícímu/Instituci veškeré informace (dokumenty) potřebné dle platných právních předpisů pro řádné provedení hodnocení a tyto předané informace (včetně Protokolu) jsou úplné a správné pro účely provádění hodnocení. Společnost INC Research se zavazuje neprodleně informovat Instituci o ukončení hodnocení (předčasném nebo v řádném předpokládaném termínu). Dále je společnost INC REsearch povinna Instituci neprodleně informovat v případě, že SúKL pozastaví nebo zakáže provádění hodnocení a dále
Trial Conduct. Institution agrees the Trial will be conducted at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Institution and Investigator under this Agreement; (iii) all applicable laws, rules, regulations and guidance of the Czech Republic in which the Trial is conducted, including, without limitation, the applicable directives of the European Union, including those related to the conduct of human clinical trials and the protection of personal data (95/46/EEC) and all applicable anti- corruption, anti-kickback, and fraud and abuse statutes; (iv) good clinical practice requirements as may be published by the International Conference on Harmonisation Harmonised Tripartite Guidelines for Good Clinical Practice (“ICH- GCP”), including, without limitation, GCP (ICH- E6), clinical safety data management (ICH-E2A) and general considerations for clinical trials (ICH- E8); and (v) generally accepted treatment standards of the medical profession. Institution shall be solely responsible for any liabilities resulting from any failure by Institution to perform in accordance with the foregoing requirements. Institution will not deviate from the Protocol without the advance written consent of Gilead, unless in the good medical judgment of Investigator, a deviation is necessary to protect the safety of the Trial subjects due to emergent or urgent medical conditions, in which case Investigator or Institution (as applicable) shall notify Gilead orally of such deviation and the justification for it within twenty- four (24) hours after its occurrence and provide a written report to Gilead within five (5) business days after the occurrence of such deviation.
Trial Conduct. Institution agrees the Trial will be conducted at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Institution under this Agreement; 1.2 Provádění studie. Instituce bude provádět Studii centru studie v přísném souladu s (i) Protokolem; (ii) se závazky Instituce dle této Smlouvy; (iii) ustanoveními všech příslušných
