Nábor subjektů Sample Clauses

Nábor subjektů. Zdravotnické zařízení ve spolupráci s hlavním zkoušejícím poskytne CRO příležitost prověřit a schválit obsah veškerých materiálů týkajících se náboru do klinického hodnocení zaměřených na potenciální subjekty klinického hodnocení před tím, než tyto materiály použije. Tento požadavek se vztahuje na veškeré takové materiály bez ohledu na médium.
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Nábor subjektů. Hlavní zkoušející poskytne CRO příležitost prověřit a schválit obsah veškerých materiálů týkajících se náboru do Studie zaměřeného na potenciální Subjekty studie před tím, než tyto materiály použije. Tento požadavek se vztahuje na veškeré tyto materiály bez ohledu na médium.
Sample 1
Nábor subjektů. 4.1 The Trial will be initiated only when the Sponsor has received appropriate Ethics Committee approval of any national regulatory approvals as required and in accordance with the applicable laws and such is documented to the Institution. 4.1 Klinické hodnocení bude zahájeno jen tehdy, až zadavatel obdrží schválení příslušné etické komise a všechna schválení národních regulačních úřadů, jak jsou vyžadována platnými zákony, a příslušné dokumenty budou předloženy instituci. Site agrees to screen and randomize a sufficient number of subjects up to x randomized evaluable cases ("Designated Subject Total"). Upon review by the Trial Sponsor of the first x subjects enrolled by the Investigator and based on prior approval of Sponsor, the Designated Subject Total may be incrementally increased. Pracoviště souhlasí, že provede screening a randomizaci dostatečného počtu subjektů až do x (x) randomizovaných hodnotitelných případů („stanovený celkový počet subjektů“). Poté, co zadavatel klinického hodnocení přezkoumá první xsubjekty zařazené zkoušejícím a na základě předchozího souhlasu zadavatele lze stanovený celkový počet subjektů postupně zvyšovat. The Investigator understands and agrees that reasonable efforts shall be made to randomize all subjects before x. Estimated Trial duration is: 2 years. No subjects may be randomized after this date without written authorization from Trial Sponsor. All subjects who do not meet the criteria for evaluable cases will not be paid. Zkoušející rozumí a souhlasí, že vyvine přiměřené úsilí k randomizaci všech subjektů do x. Předpokládaná doba trvání klinického hodnocení je: 2 roky. Po tomto datu již nelze randomizovat žádné subjekty bez písemného schválení zadavatele klinického hodnocení. Žádné subjekty, které nesplňují kritéria pro hodnotitelné případy, nebudou uhrazeny. Sponsor and UBC agree to collect, use and disclose data (which is not indentifiable per standard clinical pratice) collected or produced in the Trial (“Subject Data”) only for the purpose of, and utilizing the results of, the Trial and related studies , and for the purpose of complying with Applicable Law, provided that all such uses are disclosed in the informed consent form or are otherwise in accordance with Applicable Law. Sponsor and UBC will use best efforts to protect the privacy and security of Subject Data and Data of Institution, Investigator and Trial staff. Zadavatel a společnost UBC souhlasí se shromažďováním, použitím a zveřejněním údajů (které ne...
Sample 1
Nábor subjektů. 4.1 Investigator shall commence recruitment of Subjects into the Study during the enrolment period provided the necessary approval has been attained from the EC. 4.1 Zkoušející zahájí nábor subjektů do klinického hodnocení během období náboru za předpokladu, že bylo získáno požadované schválení od EK.
Sample 1
Nábor subjektů. Enrollment for the Study is competitive. Institution acknowledges that this is a Study designed to evaluate a set number of subjects. Institution will be expected to apply reasonable efforts for enrollment. An “Evaluable Subject” is one who has been properly screened and meets all eligibility criteria in accordance with the Protocol. When enrollment of the target number of subjects for the entire Study is complete, Institution will be notified and instructed not to continue enrolling subjects. Zařazování do studie je kompetitivní. Poskytovatel zdravotních služeb bere na vědomí, že tato studie je navržena pro hodnocení určitého počtu subjektů. Od Poskytovatele zdravotních služeb se očekává vyvinutí přiměřeného úsilí při náboru. „Hodnotitelný subjekt“ je subjekt, který podstoupil řádný screening a splňuje všechna kritéria způsobilosti v souladu s protokolem. Jakmile bude při zařazování dosaženo cílového počtu subjektů pro celou studii, Poskytovateli zdravotních služeb bude tato skutečnost oznámena a obdrží pokyn, aby již v dalším náboru subjektů nepokračovalo.
Sample 1
Nábor subjektů. 4.1. Investigator shall promptly commence recruitment of Subjects into the Study during the enrollment period ( ). The estimated number of enrolled Subjects is . 4.1. Zkoušející zahájí nábor subjektů do studie v průběhu náborového období ( ). Předpokládaný počet zařazených subjektů je .
Sample 1
Nábor subjektů. Hlavní zkoušející umožní CRO provést kontrolu a odsouhlasit obsah veškerých náborových materiálů týkajících se studie adresovaných potenciálním subjektům studie, a to ješte pšed použitím takových materiálů. Tento požadavek se vztahuje na veškeré tyto materiály bez ohledu na prostšedek. Pšedpokládaný počet zašazených subjektů hodnocení: pšibližne 10 - 15. 7.3 Nežádoucí pšíhody. Poskytovatel zajistí, aby byly prostšednictvím hlavního zkoušejícího nahlášeny nežádoucí pšíhody zjištené u subjektů studie v souladu s pokyny uvedenými v protokolu a platných pšedpisech. Toto zahrnuje, pokud je to vyžadováno, okamžité hlášení CRO a/nebo společnosti Pfizer telefonicky nebo faxem. V souladu s tím bude mít CRO a/nebo společnost Pfizer, pokud je to zákonné, plnou odpovednost za hlášení jakýchkoliv nežádoucích pšíhod místním a mezinárodním regulačním či zdravotnickým 8. Investigational Drug. CRO will arrange for Institute to receive, at no charge, sufficient quantities of the Pfizer product that is being studied (“Pfizer Drug”) to allow Principal Investigator to conduct the Study. Unless otherwise indicated in Attachment A (Study Budget and Payment Terms), CRO will also arrange for Institute to receive at no charge, or will cover the costs of, any other Protocol- required drugs (e.g., placebo, comparator drug, concomitant drug). Any other Protocol-required drug that CRO provides or covers the cost of is, together with the Pfizer Drug, considered “Investigational Drug.” The Investigational Drug shall by supplied to the Provider’s hospital pharmacy and will be labeled for the Study. 8.1
Sample 1
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Nábor subjektů. Hlavní zkoušející umožní CRO provést kontrolu a odsouhlasit obsah veškerých náborových materiálů týkajících se studie adresovaných potenciálním subjektům studie, a to ještě před použitím takových materiálů. Tento požadavek se vztahuje na veškeré tyto materiály bez ohledu na prostředek.
Sample 1
Nábor subjektů. 4.1 Investigator shall commence recruitment of Subjects into the Study during the enrollment period, which will be running from January 2016 to March 2017. Investigator shall make a reasonable effort to enroll eligible Subjects on a competitive enrollment basis up to a target of six (6) Subjects unless Investigator obtains prior written approval from Sponsor or CRO to enroll additional Subjects. 4.1 Zkoušející zahájí nábor subjektů do studie v průběhu vstupního období, které bude probíhat od ledna 2016 do března 2017 Zkoušející vynaloží veškerou možnou snahu k zařazení způsobilých subjektů na základě výběrového náboru až do cílového počtu šesti (6) subjektů, pokud zkoušející nedostane písemné oprávnění od zadavatele nebo CRO k zařazení dalších subjektů.
Sample 1

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