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 agrees
Trial Conduct. 5 Provádění Klinického hodnocení
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 country 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. Provádění Klinického hodnocení. Zdravotnické zařízení souhlasí s tím, že Klinické hodnocení bude provedeno v Místě výkonu klinického hodnocení v přísném souladu s (i) Protokolem; (ii) povinnostmi Zdravotnického zařízení a Zkoušejícího dle této Smlouvy; (iii) všemi příslušnými právními předpisy země, kde je prováděno Klinické hodnocení, zejména platnými směrnicemi Evropské unie, včetně těch, které souvisí s výkonem klinických hodnocení na lidských subjektech a s ochranou osobních údajů (95/46/EEC), a veškerých platných protikorupčních zákonů a zákonů na ochranu proti úplatkářství, podvodům a zneužívání; (iv) požadavky správné klinické praxe, které mohou být zveřejněny Mezinárodní konferencí o harmonizaci harmonizovaných trilaterálních směrnic správné klinické praxe („ICH-GCP”), zejména, GCP (ICH-E6), správou úd...
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 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 nebo pojišťoven, platbu za 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.
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 after its occurrence and provide a written report to Gilead within five (5) business days after the zaplatila společnost Gilead.
Trial Conduct. Institutionwill conduct the Trial in accordance with the Protocol, Sponsor’s or its designee’s written instructions and Applicable Law. 4. Vykonávanie Hodnotenia Inštitúcia bude toto Hodnotenie realizovať v súlade s Protokolom, písomnými pokynmi Zadávateľa alebo ním poverenej osoby a v súlade s Príslušnými zákonnými predpismi.
Trial Conduct. P rovádění klinického hodnocení. Institution 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 hereby is 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. Zdravotnické zařízení bude provádět klinické hodnocení v souladu s protokolem, písemnými pokyny zadavatele nebo jeho zástupce/ dodavatele třetí strany (včetně CRO) a platnými zákony. Zdravotnické zařízení poskytne vhodné zdroje a prostory, aby mohl zkoušející provádět klinické hodnocení včas a profesionálně a podle podmínek této smlouvy. Zadavatel určil CRO jako monitora klinického hodnocení a zdravotnické zařízení je tímto oprávněno komunikovat přímo s CRO s ohledem na monitorování tohoto klinického hodnocení. Bez ohledu na výše uvedené, jakékoli oznámení, které musí být podle této smlouvy předáno zadavateli, nebude považováno za doručené, pokud je toto oznámení předáno výlučně CRO. Sponsor shall be responsible for the performance of statutory obligations in relation to SÚKL, Ethics Committees and, where applicable, other regulatory authorities, including notification of initiation and termination of the clinical trial, adverse event reporting, notification of new circumstances and measures adopted and other information obligations, informed consent form approval and its revisions and Protocol amendment approvals. Zadavatel odpovídá za plnění zákonných povinností ve vztahu k SÚKL a etickým komisím, případně k jiným regulačním úřadům, a to včetně ohlášení zahájení a ukončení klinického hodnocení, podávání zpráv a hlášení nežádoucích účinků, oznámení nových skutečností a přijatých opatření a dalších informačních povinností, schválení informovaného souhlasu a jeho změn, schválení dodatků k Protokolu, a také za jednání vůči SÚKL a etickým komisím v souvislosti s tímto klinickým hodnocením. Sponsor represents that any and all information furnished for the purpose of conducting the clinical trial (including the Protocol) are complete and correct for t...
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.
