Modification. The Protocol may not be unilaterally modified by the PRINCIPAL INVESTIGATOR; it requires prior approval and consent by the SPONSOR. Any modification to the authorized Protocol shall be notified to the relevant Ethics Committee, the Agencia Española de Medicamentos y Productos Sanitarios, and shall have the approval of the Principal Investigator of the Study. Any modifications or amendments to the Protocol shall be notified to the SITE, through the local DREC. The site may, if such modifications or amendments are considered as essential, either terminate the agreement or by mutual agreement with the Sponsor, proceed with the renewal of the contract. 2.4.- Ethical and legal Standards.
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