OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR. The Principal Investigator shall comply with all of the obligations established in Article 10 of Royal Decree 957/2020. The Principal Investigator agrees to carry out all of the tasks necessary for the performance of the Study. The Principal Investigator agrees to: Coordinate, supervise and manage the collaborators. Include, prior to the end of the Study, an estimated number of [•] patients. Within the framework of current legal requirements applicable to this matter, patients must receive as much information as possible, and their consent form must be obtained in writing. Perform follow-up on the patients in accordance with the criteria of the Protocol and current regulations applicable to this area. Collect and store all the Study information and deliver all documents to the Monitor or the Sponsor in accordance with the Protocol. Immediately report all the adverse reactions, including the unexpected and serious adverse reactions, using the fastest means available, to the Study Monitor appointed by the Sponsor. Follow the instructions regarding the communication of adverse events established in the Protocol and in the Royal Decree 957/2020. Communicate to the Sponsor the number of patients who have not attended the monitoring visits, in order to obtain the necessary reserve medication in time. Provide the Sponsor/Monitor with the information on each visit as soon as the visit occurs, in order to verify the information provided and its consistency with the information provided during previous or subsequent visits. Respect the confidential nature of the clinical data of each participant and maintain their privacy. Collaborate with the Monitor and/or his collaborator/s in order to guarantee the correct quality control of the Study, particularly with regard to the following elements: available resources, adherence to the Protocol, comparison of observation sheets and the HUVH clinical dossier (Medical Records), samples and recruitment. In case of the Principal Investigator cease his functions as HUVH’s physician or, in any manner, stop participating in the Study, the Principal Investigator and/or the VHIO agree to propose a suitable replacement and to manage their acceptance in order to ensure the Study continuity. In the event of international registration, the relevant forms shall be completed.
OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR. The study that is the subject matter of this agreement shall be conducted under the direct and personal responsibility of the principal investigator, who shall ensure that it is conducted in accordance with the requirements and conditions set forth in the pertinent administrative authorization. The principal investigator declares before the center and the health authorities that he/she has the training to properly fulfill this agreement, for which purpose he/she has an appropriate team of collaborators consisting of: Dr. <<collaborator>> (<<department>>department) The principal investigator and the collaborators assume the obligations stipulated for each one of them in Section 6 of Order SAS/3470/2009 of December 16.
OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR. 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 RD 1090/2015. Specifically, the Principal Investigator agrees to: Coordinate, supervise and manage the collaborators.
