DUTY OF COOPERATION a) In general, the participating entities shall cooperate with each other in the compliance with the GDPR and other applicable regulations, providing to the other entities the information required to facilitate and demonstrate compliance, according to the applicable regulations and the distinct roles of the parties. b) The Principal Investigator shall cooperate with the Sponsor or entity they delegate (monitor) to perform their duties related to ensuring that the clinical Study is being conducted as required by the applicable regulations and the Protocol, including checking the security measures taken, for which it may carry out as many checks or audits as it is deemed necessary, being able to access identifying personal data for this purpose. In no case can the Sponsor or Monitor obtain a copy of information or documents containing data that may directly identify the Study subjects. c) In the event that any of the participating entities suspects a lack of compliance with the personal data protection regulations, within 24 hours of finding out, they shall report this to the other entities and their data protection officers, as applicable depending on the circumstances of the case, who shall determine which parties must be involved in the investigation of the events. d) The participating entities, with regard to the processing of the clinical Study data, also agree to inform the other entities of: - The start of any investigation or opening of an inquiry by the data protection control authority. - Any administrative, legal or preparatory process related to the protection of personal data, as well as any decision, order or resolution issued in this regard. - Any incidents affecting the right to data protection of subjects and/or people participating in the Study, including the accidental or unauthorised access, modification, loss, damage, destruction or anything else affecting the personal data. VII.- EXERCISE OF THE RIGHTS OF THE DATA SUBJECTS The exercise of the rights regulated by the data protection regulations and the withdrawal of consent to the processing of the data shall be exercised with the Principal Investigator who is obliged to inform the corresponding Data Controller (if necessary in pseudonymised form) to resolve it promptly and in the manner established by law. In the event that a subject participating in the clinical Study exercises its rights through an entity or person other than the Principal Investigator, this entity or person shall ins...
