Common use of OBLIGATIONS OF THE PRINCIPAL INVESTIGATOR Clause in Contracts

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. Include, prior to the end of the Trial, 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 Trial 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 Trial Monitor appointed by the Sponsor. Follow the instructions regarding the communication of adverse events established in the Protocol. 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. Attend and participate in person or through delegation at the meetings of researchers and investigators held over the course of the Trial. Collaborate with the Monitor and/or his collaborator/s in order to guarantee the correct quality control of the Trial, 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. Should the Principal Investigator cease his functions as VHIR’s investigator or as HUVH’s physician or, in any manner, stop participating in the Trial, the Principal Investigator and/or the VHIR agree to propose a suitable replacement and to manage their acceptance in order to ensure the Trial continuity. In the event of international registration, the relevant forms shall be completed.

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. Include, prior to the end of the Trial, 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 Trial 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 Trial Monitor appointed by the Sponsor. Follow the instructions regarding the communication of adverse events established in the Protocol. 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. Attend and participate in person or through delegation at the meetings of researchers and investigators held over the course of the Trial. Collaborate with the Monitor and/or his collaborator/s in order to guarantee the correct quality control of the Trial, 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. Should the Principal Investigator cease his functions as VHIR’s investigator or as HUVH’s physician or, in any manner, stop participating in the Trial, the Principal Investigator and/or the VHIR VHIO agree to propose a suitable replacement and to manage their acceptance in order to ensure the Trial continuity. In the event of international registration, the relevant forms shall be completed.

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 Trial, which are regulated for this purpose in article 41 of RD 1090/2015Study. Specifically, the The Principal Investigator agrees to: Coordinate, supervise and manage the collaborators. Include, prior to the end of the TrialStudy, 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 Trial 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 Trial Study Monitor appointed by the Sponsor. Follow the instructions regarding the communication of adverse events established in the ProtocolProtocol 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. Attend and participate in person or through delegation at the meetings of researchers and investigators held over the course of the Trial. Collaborate with the Monitor and/or his collaborator/s in order to guarantee the correct quality control of the TrialStudy, 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. Should In case of the Principal Investigator cease his functions as VHIR’s investigator or as HUVH’s physician or, in any manner, stop participating in the TrialStudy, the Principal Investigator and/or the VHIR VHIO agree to propose a suitable replacement and to manage their acceptance in order to ensure the Trial Study continuity. In the event of international registration, the relevant forms shall be completed.

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 Trial, which are regulated for this purpose in article 41 of RD 1090/2015Study. Specifically, the The Principal Investigator agrees to: Coordinate, supervise and manage the collaborators. Include, prior to the end of the TrialStudy, 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 Trial 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 Trial Study Monitor appointed by the Sponsor. Follow the instructions regarding the communication of adverse events established in the ProtocolProtocol 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. Attend and participate in person or through delegation at the meetings of researchers and investigators held over the course of the Trial. Collaborate with the Monitor and/or his collaborator/s in order to guarantee the correct quality control of the TrialStudy, 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. Should In case of the Principal Investigator cease his functions as VHIR’s investigator or as HUVH’s physician or, in any manner, stop participating in the TrialStudy, the Principal Investigator and/or the VHIR agree to propose a suitable replacement and to manage their acceptance in order to ensure the Trial Study continuity. In the event of international registration, the relevant forms shall be completed.