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 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 agrees
Trial Conduct. 5 Provádění Klinického hodnocení
Trial Conduct. Institution will conduct the Trial in accordance with the Protocol, Sponsor’s or its designee’s written instructions and Applicable Law. 4. Výkon skúšania. Inštitúcia bude vykonávať Skúšanie v súlade s Protokolom, písomnými pokynmi Sponzora alebo ním určenej osoby a 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 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 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); (v) generally accepted treatment standards of the medical profession, and
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 and Investigator shall be solely responsible for any liabilities resulting from any failure by Institution to perform in accordance with the foregoing requirements. Institution herein acknowledges, that Investigator 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 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. The Trial will be conducted on the basis of Approval of 1.2
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;
Trial Conduct. Provider and Investigator will conduct the Trial at the Trial Site in strict compliance with (i) the Protocol; (ii) the obligations of Provider 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. Provider shall be solely responsible for any liabilities resulting from any failure by Provider to perform in accordance with the foregoing requirements. Neither Provider nor Investigator will deviate from the Protocol without the advance written consent of Sponsor, 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 Provider shall notify Sponsor orally of such deviation and justification for it within twenty-four (24) hours after its occurrence and provide a written report to Sponsor within five (5) business days after the occurrence of such deviation.
