Insurance cover. 8.1 The Sponsor/CRO confirms that it has taken out a third party liability insurance policy (no. _____, with the insurer _____) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009). The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial.
8.2 Subject to the provisions of law no. 24 of 8 March 2017, the insurance cover provided by the Sponsor is guaranteed with regard to the civil liability of the Sponsor, as well as the healthcare facility at which the Trial will take place, the Principal Investigator, and the other investigators involved at the Entity’s Centre.
8.3 The Sponsor is liable for any consequences resulting from any present or future deficiencies in the insurance cover mentioned above.
8.4 In particular, in the event that the Sponsor intends to withdraw from the Agreement, the Sponsor warrants that the insurer shall in all cases guarantee the cover of the patients already included in the clinical trial also during the continuation of the Trial, in accordance with Article 2 para. III of M.D. of 17/07/09.
8.5 It is acknowledged that the Entity has insurance policies for Medical Malpractice (“MEDMAL”) stipulated to cover both the Entity and the medical staff administering the drug, in accordance with article 1910 of the Italian Civil Code.
(c) In the case of observational studies on drugs
Insurance cover. Considering the observational nature of the proposed study, a specific insurance policy is not required.
Insurance cover. Il Promotore è tenuto a garantire, secondo la legislazione vigente, il risarcimento dei danni subiti dai pazienti e riconducibili alla partecipazione alla sperimentazione clinica secondo il Protocollo, commisurato alla natura e alla portata dei rischi conseguenti.
Insurance cover. The Department of Chemistry pays for a personal insurance policy which is included in scholarships. It is compulsory to cover scholarship holders against accidents taking place while doing their research on university or external premises even with the Scientific Co-ordinator’s authorization. It is also valid for civil liability should the scholarship holder cause damage to persons or property. Candidates should refer to the relevant Central Administration offices for insurance policy enquiries.
Insurance cover. Le Parti riconoscono che, trattandosi di studio osservazionale, non è necessario stipulare specifica polizza assicurativa per la 7.1 The Parties acknowledge that, being an observational study, , it is not necessary to stipulate a specific insurance policy for civil responsabilità civile verso i pazienti, la cui copertura ricade nel programma di gestione del rischio nell’ambito della normale pratica clinica. liability towards patients, the coverage of which falls within the risk management program as part of the standard clinical practice.
Insurance cover. 8.1 The Sponsor is required to guarantee, according to current legislation, compensation for damages suffered by patients and attributable to participation in the clinical Trial, commensurate with the nature and extent of th e consequent risks.
8.2 Il Promotore dichiara, , di aver stipulato adeguata polizza assicurativa (n. MCICET21346, con la Compagnia Llyod’s Insurance Company S.A.) per la responsabilità civile verso terzi, a copertura del rischio di eventuali danni derivanti ai pazienti dalla partecipazione alla Sperimentazione, secondo quanto previsto dal D.M. 14 luglio 2009. La polizza assicurativa è stata ritenuta dal Comitato Etico rispettosa dei termini di legge e adeguatamente tutelante i soggetti coinvolti nella Sperimentazione clinica.
8.3 Fatte salve le previsioni dell’art 76 del Regolamento (UE) n. 536/2014 e della L. 8 Marzo 2017, n. 24 e dei rispettivi provvedimenti attuativi, la copertura assicurativa fornita dal Promotore garantisce rispetto alle ipotesi di responsabilità civile del Promotore, dell’istituzione sanitaria sede della Sperimentazione, dello Sperimentatore Principale, e degli altri Sperimentatori coinvolti presso il Centro dell'Ente.
8.4 Il Promotore, con la firma del presente contratto, dichiara di farsi carico delle conseguenze connesse a eventuali inadeguatezze, anche sopravvenute, della copertura assicurativa in argomento.
8.5 Il Promotore in particolare, nel caso in cui intenda recedere dal Contratto, garantisce che la Società assicuratrice assicuri in ogni caso la copertura dei soggetti già inclusi nello studio clinico anche per il prosieguo della Sperimentazione ai sensi dell'art. 2 comma III del D.M. 17/07/09.
8.6 All’atto del sinistro, Ente è tenuto a comunicare l’esistenza di coperture assicurative per la responsabilità RCT Medical Malpractice (sia a copertura dell’Ente, che del personale medico che ha somministrato il farmaco), ai sensi dell’articolo 1910 codice civile.
Insurance cover. 8.1 The Sponsor is required to guarantee, according to current legislation, compensation for damages suffered by patients and attributable to participation in the clinical Trial, in accordance with the Protocol, commensurate with the nature and extent of the consequent risks.
8.2 Without prejudice to the provisions of Article 76 of the Regulation and of Law 8 March 2017, n. 24 and the respective implementing measures, the insurance coverage provided by the Sponsor guarantees with respect to the hypotheses of civil liability of the Sponsor, the health entity where the Trial is conducted, the Principal Investigator, and the other Investigators involved at the Entity.
8.3 The Sponsor confirms, by signing this Agreement, that it has taken out a third party liability insurance policy (no. ITLSCQ90311, with the insurer Chubb European Group SE) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009. The Ethics Committee considered that the insurance policy complies with the provisions of the law and adequately protects the patients
8.4 The Sponsor confirms, by signing this Agreement, that it is liable for any consequences resulting from any present or future deficiencies in the insurance cover mentioned above, integrating them where necessary in accordance with the provisions of Article 8.1.
8.5 In particular, in the event that the Sponsor intends to withdraw from the Agreement, the Sponsor warrants that the insurer shall in all cases guarantee the coverage of patients already included in the clinical trial also during the continuation of the Trial, in accordance with Article 2 par. 3 of M.D. of 17/07/09. 8.6 At the time of the accident, the Entity is required to disclose the existence of policies for liability RCT Medical Malpractice (to cover the Entity and the medical staff administering the drug) in accordance with Article 1910 of the Italian Civil Code.
Insurance cover. Il Promotore dichiara di aver stipulato adeguata polizza assicurativa (n. WIBCET22185, con la Compagnia Lloyd’s Insurance Company S.A. Belgio) per la responsabilità civile verso terzi, a copertura del rischio di eventuali danni derivanti ai pazienti dalla partecipazione alla Sperimentazione, secondo quanto previsto dal D.M. 14 luglio 2009. La polizza assicurativa è stata ritenuta dal Comitato Etico rispettosa dei termini di legge e adeguatamente tutelante i soggetti coinvolti nella Sperimentazione clinica.
Insurance cover. Il Promotore/CRO dichiara di aver stipulato adeguata polizza assicurativa (n. 30360876, con la Compagnia Allianz Global Corporate & Specialty SE) per la responsabilità civile verso terzi, a copertura del rischio di eventuali danni derivanti ai pazienti dalla partecipazione alla Sperimentazione, secondo quanto previsto dal D.M. 14 luglio 2009). La polizza assicurativa è stata ritenuta dal Comitato Etico rispettosa dei termini di legge e adeguatamente tutelante i soggetti coinvolti nella Sperimentazione clinica. 8.1 The Sponsor/CRO confirms that it has taken out a third party liability insurance policy (no. 30360876, with the insurer Allianz Global Corporate & Specialty SE) to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009). The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial.
Insurance cover. Il Promotore/CRO dichiara di aver stipulato adeguata polizza assicurativa n. ITLSCQ76470, con la Compagnia Chubb European Group SE per la responsabilità civile verso terzi, a copertura del rischio di eventuali danni derivanti ai pazienti dalla partecipazione alla Sperimentazione, secondo quanto previsto dal D.M. 14 luglio 2009. La polizza assicurativa è stata ritenuta dal Comitato Etico rispettosa dei termini di legge e adeguatamente tutelante i soggetti coinvolti nella Sperimentazione clinica. 8.1 The Sponsor/CRO confirms that it has taken out a third party liability insurance policy no. ITLSCQ76470, with the insurer Chubb European Group SE to cover the risk of injury to patients from taking part in the Trial, in accordance with M.D. of 14 July 2009. The Ethics Committee considers that the insurance policy complies with the provisions of the law and adequately protects the patients taking part in the Trial.