Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Janssen. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify CRO and Janssen immediately. Používání randomizačních kódů: Hlavní zkoušející provádějící zaslepené klinické hodnocení se zavazuje, že zachová zaslepení Hodnoceného léčivého přípravku. Hlavní zkoušející je srozuměn s tím, že randomizační kódy budou uvolněny až po dokončení Klinického hodnocení a finalizace databáze společností Janssen. U multicentrických klinických hodnocení bude nutné získat údaje ze všech center, než bude možné považovat Klinické hodnocení za dokončené. Bude-li v naléhavém zdravotním případě nezbytné, aby Hlavní zkoušející prolomil kód u konkrétního pacienta, zavazuje se, že o tom bude neprodleně informovat CRO a společnost Janssen.
Use of Randomization Codes. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Xxxxxxx. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify Xxxxxxx immediately.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Sponsor. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify CRO immediately.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Sponsor. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify CRO immediately. For the performance of the Clinical Trial, Sponsor shall provide the Study Product and CRO shall provide all Clinical Trial related documents (such as case report forms) and any materials and equipment set forth in Exhibit A. Neither Institution nor Principal Investigator shall make any use of Study Product and Clinical Trial related documents, materials and equipment other than for the performance of the Clinical Trial in accordance with the Protocol. Sponsor or the Sponsor’s designee shall ensure appropriate and timely supply of the Study Product necessary for the performance of the Study. The Study Product shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Product be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Product Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant pursuant to Applicable law, who shall be responsible for Study Product Handling and keeping full records thereon. Immediately after appointing such agent, Institution shall notify CRO in writing of the name and surname of the appointee(s) along with the appropriate contact details, if applicable. Investigator hereby undertakes to draw the Study Product from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visit. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Product (as hazardous waste) in accordance with the Applicable Law, if requested to do so by Sponsor or CRO.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Xxxxxxx. For multi-center studies, V prípade zaslepenia klinického skúšania; Používanie randomizačných kódov: Zodpovedný skúšajúci vykonávajúci zaslepené skúšanie súhlasí, že zachová zaslepenie skúšaného produktu. Zodpovedný skúšajúci berie na vedomie, že randomizačné kódy sa zverejnia až po dokončení klinického skúšania a uzavretí databázy spoločnosťou Janssen. V prípade
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Sponsor. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify CRO immediately. 1.5 For the performance of the Clinical Trial, Sponsor shall provide the Study Product and CRO shall provide all Clinical Trial related documents (such as case report forms) and any materials and equipment set forth in Exhibit A. Neither Institution nor Principal Investigator shall make any use of Study Product and Clinical Trial related documents, materials and equipment other than for the performance of the Clinical Trial in accordance with the Protocol. Sponsor or the Sponsor’s designee shall ensure appropriate and timely supply of the Study Product necessary for the performance of the Study. The Study Product shall be supplied, free of charge, to Institution’s pharmacy. Institution hereby undertakes to ensure that the Study Product be stored separately from other medication in the pharmacy, and its preparation, inspecting, preserving and dispensing (hereinafter only “Study Product Handling”) be performed in compliance with Protocol and Study Instructions, and the Applicable Law, as well as the terms and conditions stipulated by LEK-12 Directive issued by State Institute for Drug Control. Institution shall appoint agent/agents meeting professional qualification criteria for the medical position of a pharmacist or pharmaceutical assistant zdravotních služeb a Hlavní zkoušející budou odpovědni za jakékoliv porušení této Smlouvy těmito osobami. Poskytovatel zdravotních služeb a Hlavní zkoušející zajistí, aby se Hlavní zkoušející a jím určení pracovníci účastnili všech školení pořádaných Zadavatelem, Smluvní výzkumnou organizací a jimi určenými osobami ohledně řádného plnění Protokolu, bezpečnosti a povinnosti podávání zpráv a jakýchkoliv ostatních platných předpisů týkajících se Klinického hodnocení a plnění Protokolu. Použití randomizačních kódů: Hlavní zkoušející provádějící zaslepenou studii souhlasí s tím, že bude udržovat zaslepení hodnoceného léčiva. Hlavní zkoušející souhlasí, že randomizační kódy bu...
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Xxxxxxx. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify V prípade zaslepenia klinického skúšania; Používanie randomizačných kódov: Zodpovedný skúšajúci vykonávajúci zaslepené skúšanie súhlasí, že zachová zaslepenie skúšaného produktu. Zodpovedný skúšajúci berie na vedomie, že randomizačné kódy sa zverejnia až po dokončení klinického skúšania a uzavretí databázy spoločnosťou Janssen. V prípade multicentrických skúšaní sa klinické skúšanie považuje za dokončené až po získaní údajov zo všetkých pracovísk skúšania. V prípade rýchlej lekárskej pomoci, ktorá by od zodpovedného skúšajúceho vyžadovala odslepenie kódu pre Xxxxxxx immediately. niektorého účastníka, zodpovedný skúšajúci súhlasí, že o tom bude bezodkladne informovať spoločnosť Xxxxxxx.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The Principal Investigator understands that the randomization codes will be released upon completion of the Clinical Trial and finalization of the database by Sponsor. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify CRO immediately. For the performance of the Clinical Trial, Sponsor shall provide the Study Product and CRO shall provide all Clinical Trial related documents (such as case report forms) and any materials and equipment set forth in Exhibit A. Neither Institution nor Principal Investigator shall make any use of Study Product and Clinical Trial related documents, materials and equipment other than for the performance of the Clinical Trial in accordance with the Protocol. Sponsor or the Sponsor’s designee shall ensure appropriate and timely supply of the Study Product necessary for the performance of the Study. The Institution hereby undertakes to perform/ensure safe liquidation/disposal of unused Study Product (as hazardous waste) in accordance with the Applicable Law, if requested to do so by Sponsor or CRO.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. For multi-center studies, data from all centers are required before the Clinical Trial is considered complete. Should a medical V prípade zaslepenia klinického skúšania; Používanie randomizačných kódov: Zodpovedný skúšajúci vykonávajúci zaslepené skúšanie súhlasí, že zachová zaslepenie skúšaného produktu. V prípade multicentrických skúšaní sa klinické skúšanie považuje za dokončené až emergency occur requiring the Principal Investigator to break the code for a specific subject, the Principal Investigator agrees to notify Janssen immediately. po získaní údajov zo všetkých pracovísk skúšania. V prípade rýchlej lekárskej pomoci, ktorá by od zodpovedného skúšajúceho vyžadovala odslepenie kódu pre niektorého účastníka, zodpovedný skúšajúci súhlasí, že o tom bude bezodkladne informovať spoločnosť Janssen.
Use of Randomization Codes. The Principal Investigator conducting a blinded study agrees to maintain the blinding of the Study Product. The V případě zaslepení klinického hodnocení použijte randomizační kódy: Hlavní zkoušející provádějící zaslepenou studii souhlasí s tím, že bude zachovávat zaslepení hodnoceného
