of the Trial or when they become available, as well as unexpected and serious adverse reactions or events detected by the Sponsor. Any available new information obtained the Product during the performance of the Trial The Sponsor agrees to provide the following free of charge: The medicinal products or drugs constituting the subject matter of the Trial (known as ‘investigational medicinal product’), as defined by current legislation, in which the investigational medicinal product is the medicinal product which is being tested or used as a reference, including as a placebo, in a Clinical Trial. The auxiliary medicinal product, as defined in current legislation, understood as the medicinal product used for the needs of a clinical trial, as described in the Protocol, but not as an investigational medicinal product. The Sponsor must pay the fees of the Ethics Committee for Research with medicinal products (ECRM), in the event that they fall due and an exemption has not been granted. 7. OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR AND OF THE VHIO The Principal Investigator agrees to carry out all of the tasks necessary for the performance of the Trial, which are regulated for this purpose in article 41 of R.D. 1090/2015. Specifically, the Principal Investigator agrees to: Coordinate, supervise and manage the collaborators. Include, prior to the end of the Trial, an estimated number of [...] patients.
of the Trial or when they become available, as well as unexpected and serious adverse reactions or events detected by the Sponsor. Any available new information obtained the Product during the performance of the Trial The Sponsor agrees to provide the following free of charge: The medicinal products or drugs constituting the subject matter of the Trial (known as ‘investigational medicinal product’), as defined by current legislation, in which the investigational medicinal product is the medicinal product which is being tested or used as a reference, including as a placebo, in a Clinical Trial. The auxiliary medicinal product, as defined in current legislation, understood as the medicinal product used for the needs of a clinical trial, as described in the Protocol, but not as an investigational medicinal product. The Sponsor must pay the fees of the Ethics Committee for Research with medicinal products (ECRM), in the event that they fall due and an exemption has not been granted. 7. OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR AND OF THE VHIO The Principal Investigator agrees to carry out all of the tasks necessary for the performance of the Trial, which are regulated for this purpose in article 41 of R.D. 1090/2015. Specifically, the Principal Investigator agrees to: Coordinate, supervise and manage the collaborators. Include, prior to the end of the Trial, an estimated number of [...] patients.
VHIO-VHIR_Clinical_Trial_Template_(RD1090-2015)_ENGL.docx