 - InspectionsAudits: The Principal Investigator or personnel appointed may perform verifications throughout the study to ensure that the study is being conducted in accordance with the protocol and with the provisions of existing applicable laws. Also Regulatory Authorities may conduct inspections on the study both throughout its conduction or after completion of the study. Should a Regulatory Authority require an inspection, the Investigator must promptly notify the Ethics Committee thereof. By signing the protocol, the Investigator agrees to allows audits to be conducted both by appointed personnel and inspections by Regulatory Authorities. 