IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 4.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 3. NEK a RÚ. Smluvní strany zajistí, že klinické hodnocení bude zahájeno až po schválení klinického hodnocení a formuláře informovaného souhlasu, které jsou v souladu s platnými zákony, nezávislou etickou komisí a RÚ. Smluvní strany dále zajistí, aby po celou dobu jeho provádění bylo klinického hodnocení pod trvalým dohledem NEK a/nebo RÚ.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 3. NEK a RÚ. Smluvní strany zajistí, že klinické hodnocení bude zahájeno až po schválení klinického hodnocení a formuláře informovaného souhlasu („ICF“), které jsou v souladu s platnými zákony, nezávislou etickou komisí a/nebo RÚ. Smluvní strany dále zajistí, že klinické hodnocení bude po celou dobu provádění podléhat trvalému dohledu ze strany NEK a/nebo RÚ.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 4. Sponsor Drug. Sponsor will provide Institution and/or Principal Investigator with sufficient quantities of the Sponsor product that is being studied (“Sponsor Drug”) to conduct the Trial at no cost to the Institution. If required by the Protocol and unless otherwise agreed, Sponsor will also provide placebo or comparator drug (“Comparator Drug”) at no cost to the Institution. 4.1.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 3. IEC a RA. Zmluvné strany zaistia, aby sa skúšanie začalo až potom, čo skúšanie aj obsah formulára informovaného súhlasu (ďalej len “ICF”) schváli IEC a/alebo RA, ktorá dodržiava všetku platnú legislatívu. Zmluvné strany ďalej zaistia, že IEC a/alebo RA bude počas celého skúšania dohliadať na jeho priebeh.
IEC and RA. The Parties will ensure that the Study is initiated only after both the Study and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Sponsor will further ensure that the Study is subject to continuing oversight by the IEC and/or RA throughout its conduct. 3. NEK a RÚ. Smluvní strany zajistí, aby studie byla zahájena až potom, co studii i formulář informovaného souhlasu (dále jen „ICF“) schválí NEK a/nebo RÚ při dodržení všech platných zákonů. Zadavatel dále zajistí, že studie bude po celou dobu jejího provádění podléhat průběžnému dohledu NEK a/nebo RÚ.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. The State Institute for Drug Control approval (dated 16 April 2021) and the consent of the IEC (dated 18 March 2021) are incorporated as Attachments G and H to this Agreement. The parties expressly agree that the treatment of Trial Subjects cannot be started until all approvals and any other permits, required by Applicable Law to initiate the Trial, have been obtained; and Sponsor/CRO provided the Principal Investigator with a draft of ICF approved by an IEC and/or RA.. 3.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Protocol and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 4. Sponsor Drug. Sponsor will provide Institution and/or Principal Investigator with sufficient quantities of the Sponsor product that is being studied (“Sponsor Drug”) to conduct the Trial at no cost to the Institution. If required by the Protocol and unless otherwise agreed, Sponsor will also provide placebo or comparator drug (“Comparator Drug”) at no cost to the Institution. The Sponsor shall arrange for the delivery of the shipment of the Sponsor Drug at the pharmacy of the Institution where the pharmacist shall receive them and inspect them for damage, and in case of special transport requirements, check for adherence to such requirements, and shall confirm receipt of the shipment. Subsequently, the Investigator shall collect the Sponsor Drug based on a vzorků tkáně a biologických vzorků, a všech platných zákonů týkajících se zachování důvěrnosti, ochrany osobních údajů a bezpečnosti informací o subjektech hodnocení (souhrnně „platné zákony“). 2.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. The treatment of Trial subjects will be not started before all approvals from Ethics committees, RA and all other approvals needed for start of the Trial will be on place. 3. NEK a RÚ. Smluvní strany zajistí, že klinické hodnocení bude zahájeno až po schválení klinického hodnocení a formuláře informovaného souhlasu, které jsou v souladu s platnými zákony, nezávislou etickou komisí a/nebo RÚ. Smluvní strany dále zajistí, aby po celou dobu jeho provádění bylo klinického hodnocení xxx xxxxxxx xxxxxxxx XXX x/xxxx XX. Xxxxx subjektů hodnocení nebude zahájena, dokud nebudou obdrženy veškerá schválení etických komisí, souhlas RÚ a jakákoliv jiná povolení potřebná k zahájení 4. Sponsor Drug. Sponsor will provide Institution with sufficient quantities of the Sponsor product that is being studied (“Sponsor Drug”) to conduct the Trial at no cost to the Institution and Principal Investigator. If required by the Protocol and unless otherwise agreed, Sponsor will also provide placebo or comparator drug (“Comparator Drug”) at no cost to the Institution and Principal Investigator. Studie. 4.
IEC and RA. The Parties will ensure that the Trial is initiated only after both the Trial and the informed consent form (“ICF”) are approved by an IEC and/or RA that complies with all Applicable Law. The Parties will further ensure that the Trial is subject to continuing oversight by the IEC and/or RA throughout its conduct. 3. NEK a RÚ. Smluvní strany zajistí, že klinické hodnocení bude zahájeno až po schválení klinického hodnocení a formuláře informovaného souhlasu, které jsou v souladu s platnými zákony, NEK a/nebo RÚ. Smluvní strany dále zajistí, aby po celou dobu jeho provádění bylo klinického hodnocení pod trvalým dohledem NEK a/nebo RÚ. 4. Sponsor Drug. Sponsor will provide sufficient quantities of the Sponsor product that is being studied – with active substances nivolumab, docetaxel and prednisone (“Sponsor Drug”) – to the Provider and Principal Investigator to conduct the Trial. If required by the Protocol and unless otherwise agreed, Sponsor will also provide placebo or comparator drug (“Comparator Drug”) at no cost to the Provider and Principal Investigator. Sponsor Drugs and/or Comparator Drug shall be supplied exclusively to the Provider’s pharmacy (Ústavní lékárna), on business days from 7:00 a.m. to 3:00 p.m. Sponsor Drugs shall be unambiguously identified and addressed to the Provider’s employee responsible for the pharmaceutical part of the Trial. Disposal of any opened and unused Sponsor Drugs shall be arranged by the Provider, immediately after preparation or adjustment of the Sponsor Drug. 4.
