Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxx.xxxxxxxxxxxxxx.xxx and websites and databases that serve a comparable purpose; and (v) storage in databases to facilitate the selection of investigators for future clinical trials. Personal data may be disclosed or transferred to Gilead’s affiliates, subsidiaries, representatives, and contractors working on behalf of Gilead, and to regulatory authorities across the world. The Institution will ensure that all necessary consents are in place to allow for the uses described in this Section. The Parties hereby agree that the Trial will be conducted in accordance with applicable law, including but not limited to Act 18/2018, Coll., On Personal data protection, to the extent applicable for the Trial.
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements;
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxx.xxxxxxxxxxxxxx.xxx and websites and databases that serve a comparable purpose; and (v) storage in databases to facilitate the selection of investigators for future clinical trials. Personal data may be disclosed or transferred to Gilead’s affiliates, subsidiaries, representatives, and contractors working on behalf of Gilead, and to regulatory authorities across the world. The Institution will ensure that all necessary consents are in place to allow for the uses described in this Section.
2. TRIAL DRUG; MATERIALS ukončení Studie Instituce nebo Zkoušející zajistí, že všichni jedinci uvedení na formuláři FDA 1572 ihned uvědomí společnost Gilead o jakýchkoli změnách nebo opravách informací obsažených v podepsaném formuláři finančních informací předloženém těmito jedinci.
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxx.xxxxxxxxxxxxxx.xxx and websites and databases that serve a comparable purpose; and (v) storage in databases to facilitate the selection of investigators for future clinical trials. Personal data may be disclosed or transferred to Gilead’s affiliates, subsidiaries, representatives, and contractors working on behalf of Gilead, and to regulatory authorities across the world. The Institution will ensure that all necessary consents are in place to allow for the uses described in this Section. 1.5Osobní údaje Zaměstnanců zapojených d o výkonu klinického hodnocení. Osobní údaje spojené se Zdravotnickým zařízením, Zkoušejícím a Zaměstnanci zapojenými do výkonu klinického hodnocení budou zpracovány a uchovávány v jedné či více databázích. Takové údaje mohou být použity pro účely: (i) provedení Klinického hodnocení; (ii) ověření vládními nebo kontrolními úřady, společností Gilead, smluvní výzkumnou organizací, jejich jednateli a přidruženými osobami; (iii) dodržování zákonných a právních požadavků; (iv) zveřejnění na internetových stránkách na adrese xxx.xxxxxxxxxxxxxx.xxx a na internetových stránkách a v databázích, které slouží podobným účelům; a
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and informace. Zkoušející před zahájením Studie v Instituci kompletně vyplní, podepíše a předá společnosti Gilead nebo CRO formulář FDA (United States Food and Drug Administration) č. 1572, jak je popsán v 21 CFR §312.53. Xxxx před zahájením Studie v Instituci zajistí Zkoušející a Instituce, že Zkoušející a xxxxx jednotlivá osoba zapsaná na formuláři FDA 1572 poskytnou společnosti Gilead nebo CRO podepsaný formulář finančních informací, kde přiznají nebo popřou existenci veškerého finančního zájmu a záležitostí popsaných v 21 CFR § 54.4
(a) tak, aby společnost Gilead a její pobočky byly schopny poskytnout kompletní a přesné ujištění nebo prohlášení o poskytnutí informací, které je vyžadováno 21 CFR § 54.4(a). Xxxx xxxxx xxxx trvání této Smlouvy a po dobu jednoho (1) roku po dokončení nebo ukončení Studie Instituce nebo Zkoušející zajistí, že všichni jedinci uvedení na formuláři FDA 1572 ihned uvědomí společnost Gilead o jakýchkoli změnách nebo opravách informací obsažených v podepsaném formuláři finančních informací předloženém těmito jedinci.
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxx.xxxxxxxxxxxxxx.xxx and websites and databases that serve a comparable purpose; and (v) storage in databases to facilitate the selection of investigators for future clinical trials. Personal data may be disclosed or transferred to Gilead’s affiliates, subsidiaries, representatives, and contractors working on behalf of Gilead, and to regulatory authorities across the world. The Institution will ensure that all necessary consents are in place to allow for the uses described in this Section.
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxx.xxxxxxxxxxxxxx.xxx and websites and databases that serve a comparable purpose; and (v) storage in databases to facilitate the selection of investigators for future clinical trials. Personal data may be disclosed or transferred to Gilead’s affiliates, subsidiaries, representatives, and contractors working on behalf of Gilead, and to regulatory authorities across the world. The Institution will ensure that all necessary consents are in place to allow for the uses described in this Section. 1.9 Dati personali del Personale della Sperimentazione. Il trattamento e l’archiviazione dei dati personali relativi all’Istituto, allo Sperimentatore e al Personale della Sperimentazione avverranno tramite una o più banche dati. Questi dati potranno essere utilizzati per i seguenti scopi: (i) per la conduzione della Sperimentazione; (ii) per verifiche da parte di enti pubblici o agenzie regolatorie, di Gilead, della CRO e dei loro agenti e delle loro società affiliate; (iii) per l’ottemperanza agli obblighi giuridici e normativi; (iv) per la pubblicazione sul sito xxx.xxxxxxxxxxxxxx.xxx e sui siti e xxxxx xxxxxx dati che svolgono simili funzioni; e (v) per l’archiviazione in banche dati, al fine di agevolare la selezione di sperimentatori per future sperimentazioni cliniche. I dati personali potranno essere divulgati o trasferiti a società affiliate, società consociate, rappresentanti e appaltatori che operano per conto di Gilead, nonché alle autorità regolatorie in tutto il mondo. L’Istituto si accerterà xxx xxxxx stati adottati tutti i necessari consensi per consentire gli impieghi descritti nella presente Sezione.
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the Trial; (ii) verification by governmental or regulatory agencies, Gilead, CRO, their agents and affiliates; (iii) compliance with legal and regulatory requirements; (iv) publication on xxxx://xxx.xxxxxxxxxxxxxx.xxx/ and websites and 1.9 Osobní údaje Zaměstnanců zapojených do výkonu klinického hodnocení. Osobní údaje spojené s Institucí, Zkoušejícím a Zaměstnanci zapojenými do výkonu klinického hodnocení budou zpracovány a uchovávány v jedné či více databázích. Takové údaje mohou být použity pro účely: (i) provedení Klinického hodnocení; (ii) ověření vládními nebo kontrolními úřady, Gileadem, smluvní výzkumnou organizací, jejich jednateli a přidruženými osobami; (iii)
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed and held on one or more databases. Such data may be used for the purposes of: (i) the conduct of the 1.5 Osobní údaje Zaměstnanců zapojených do výkonu klinického hodnocení. Osobní údaje spojené se Zdravotnickým zařízením, Zkoušejícím a Zaměstnanci zapojenými do výkonu klinického hodnocení budou zpracovány a
Trial Personnel Personal Data. Personal data relating to the Institution, Investigator, and Trial Personnel will be processed příslušné EK.
