Principal Investigator and Co investigators
Principal Investigator and Co investigators 3.1 The Principal Investigator shall be supported in the execution of the Trial by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Trial, who are qualified to conduct the Trial, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO, as applicable, and who have declared their willingness to take part in the Trial (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform ancillary institutional activities in the context of the Trial (for example hospital pharmacists who prepare the trial drugs). 3.2 The Parties acknowledge that the Entity and Principal Investigator is bound by all the responsibilities and obligations imposed on their role by the applicable regulations on clinical drug trials. 3.3 This Agreement is made between the Sponsor and the Entity. The Sponsor is extraneous to the relations between the Entity, the Principal Investigator and the Co-investigators, and is thus indemnified in respect of any claim that the personnel of the Entity involved in the Study may make in relation to the Trial. 3.4 In relation to the Trial, the Principal Investigator and the Co-investigators may not receive any direct or indirect compensation from the Sponsor, nor have any contact or dealings with the Sponsor or relations of any kind that are not of a technical or scientific nature. 3.5 If the relationship between the Principal Investigator and the Entity ends for any reason, the Entity will inform the Sponsor in writing and indicate the name of a replacement. The named replacement must be approved by the Sponsor and by the competent Ethics Committee. The Entity guarantees that the new Principal Investigator is qualified to continue the Trial, that they will accept the terms and conditions of this Agreement and that they will agree to respect the Protocol when executing the Trial. Pending approval of the substantial amendment for the change of Principal Investigator, the investigator indicated by the Sponsor shall carry out the necessary trial activities. If the Sponsor does not intend to accept the replacement proposed by the Entity, or if the Entity does not propose a substitute, the Sponsor may terminate this Agreement in accordance with the provisions of A...
Principal Investigator and Co investigators 3.1 The Principal Investigator shall be supported in the execution of the Clinical Investigation by the healthcare and non-healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Clinical Investigation, who are qualified to conduct the Clinical Investigation, and who have previously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have declared their willingness to take part in the Clinical Investigation (the Co-investigators). Without affecting the foregoing, the definition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institutional activities in the context of the Clinical Investigation (for example pharmacists, IT technicians).
Principal Investigator and Co investigators 3.1 The Principal Investigator shall be supported in the execution of the Trial by the healthcare and non- healthcare personnel and by any contractors engaged by the Entity, as appointed by the Entity and operating under its responsibility for all aspects pertaining to this Trial, who are qualified to conduct the Trial, and who have pre- viously received adequate training as provided for in the applicable laws, by the Sponsor/CRO and who have de- clared their willingness to take part in the Trial (the “Co- investigators”). Without affecting the foregoing, the def- inition of “Investigators” does not include any medical or non-medical personnel who perform proprietary institu- tional activities in the context of the Trial (for example hospital pharmacists who prepare the trial drugs). 3.2 The Parties acknowledge that the Principal Investiga- tor is bound by all the responsibilities and obligations im- posed on their role by the applicable regulations on clini- cal drug trials. 3.3 This Agreement is made between the Sponsor/CRO and the Entity. The Sponsor/CRO is extraneous to the re- lations between the Entity, the Principal Investigator and the Co-investigators, and is thus indemnified in respect of any claim that the personnel of the Entity involved in the Trial may make in relation to the Trial. 3.4 In relation to the Trial, the Principal Investigator and the Co-investigators may not receive any direct or indirect compensation from the Sponsor/CRO, nor have any con- tact or dealings with the Sponsor/CRO or relations of any kind that are not of a technical or scientific nature. 3.5 If the relationship between the Principal Investigator and the Entity ends for any reason, the Entity will inform Art. 3 - Sperimentatore principale e Co-sperimenta- tori 3.1 Lo Sperimentatore principale xxxx coadiuvato xxxx'ese- cuzione della Sperimentazione dal personale, sanitario e non sanitario, nonché da eventuali collaboratori incaricati dall’Ente stesso, designati dallo stesso e operanti sotto la sua responsabilità per gli aspetti relativi alla presente Spe- rimentazione, che sia qualificato per la conduzione della Sperimentazione, che abbia ricevuto preventivamente adeguata formazione prevista dalla normativa vigente dal Promotore/CRO e che abbia manifestato la propria dispo- nibilità a partecipare alla Sperimentazione (di seguito “Co-sperimentatori”). Fermo quanto precede, non rien- tra nella definizione di ‘Sperimentatori’ il personale me- dico e non med...
