Zápis Sample Clauses

Zápis. Prior to the initiation of enrollment, Xxxxxxx will have the right to publicly register protocol summaries and site contact details from company sponsored trials of both investigational medicinal products and marketed medicinal products that meet at least one of the following criteria: (i) required to be registered by Janssen or one of its affiliates pursuant to and in accordance with applicable laws and regulations; (ii) required by the ICMJE for studies intended to be published in the international peer-reviewed literature (xxxx://xxx.xxxxx.xxx); or (iii) from company sponsored trials of both investigational and marketed medicines and products that are adequately-designed and well-controlled, whether or not required by (i) or (ii) of this section above. In accordance with the legislation of the Czech Republic, the Clinical Trial description shall be published on the internet site of State Institute for Drug Control xxx.xxxx.xx and will also be available on the website xxxxx://xxx.xxxxxxxxxxxxxxxxxxxxxx.xx/index.html and xxx.XxxxxxxxXxxxxx.xxx, as required by the legislation of the EU and the USA. In addition, equivalent websites and websites of Janssen and its affiliates may be used for registration purposes. Společnost Xxxxxxx má právo před zahájením zápisu veřejně zapsat shrnutí protokolu a kontaktní údaje pracoviště z hodnocení zadaných společností jak u hodnocených přípravků, tak u registrovaných léčiv, která splňují nejméně jedno z následujících kritérií: (i) společnost Janssen nebo jedna z jejích přidružených společností je povinna je registrovat podle platných zákonů a předpisů a v souladu s nimi; (ii) vyžaduje to ICMJE pro studie, které mají být publikovány v recenzované mezinárodní literatuře (xxxx://xxx.xxxxx.xxx); nebo (iii) z klinických studií hodnocených i registrovaných léčiv a přípravků zadaných společností, které byly odpovídajícím způsobem navrženy a dobře řízeny bez ohledu na to, zda to vyžaduje bod (i) nebo (ii) výše v tomto bodě, či nikoli. Popis klinického hodnocení bude v souladu s legislativou České republiky zveřejněn na internetových stránkách Státního ústavu pro kontrolu léčiv xxx.xxxx.xx a bude dostupný také na xxxxx://xxx.xxxxxxxxxxxxxxxxxxxxxx.xx/index.html a xxx.XxxxxxxxXxxxxx.xxx, jak požaduje legislativa EU a USA. Kromě toho lze pro registrační účely použít ekvivalentní webové stránky a oficiální webové stránky společnosti Janssen nebo jejích přidružených společností. Any person accessing a clinical trial listing for a cli...
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Zápis. Prior to the initiation of enrollment, Sponsor will have the right to publicly register protocol summaries and site contact details from company sponsored trials of both investigational medicinal products and marketed medicinal products that meet at least one of the following criteria: (i) required to be registered by Sponsor pursuant to and in accordance with applicable Zadavatel má právo před zahájením zápisu veřejně zapsat shrnutí protokolu a kontaktní údaje pracoviště z hodnocení zadaných společností jak u hodnocených přípravků, tak u léčiv, která splňují nejméně jedno z následujících kritérií: (i) zadavatel je povinen je registrovat podle platných zákonů a předpisů a v souladu s nimi; (ii) ICMJE pro studie vyžadují jejich zveřejnění v mezinárodní literatuře
Sample 1
Zápis. Prior to the initiation of enrollment, Xxxxxxx will have the right to publicly register protocol summaries and site contact details from company sponsored trials of both investigational medicinal products and marketed medicinal products that meet at least one of the following criteria: (i) Společnost Janssen má právo před zahájením zápisu veřejně zapsat shrnutí protokolu a kontaktní údaje pracoviště z hodnocení zadaných společností jak u hodnocených přípravků, tak u registrovaných léčiv, která splňují nejméně jedno z následujících kritérií: (i)
Sample 1

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