INTERNATIONAL TRANSFERS. In the event that the clinical Study requires international transfers of data to countries outside of the European Economic Area, the legal regimen established for such transfers in the GDPR and LOPDGDD shall be complied with and guarantees shall be provided in that regard. For this purpose, it is understood that there are guarantees for making international transfers when: a) They are made to a country, territory, specific industry or international organisation that has been declared to have an adequate level of protection by the European Commission. b) They are made between companies of the same group and binding corporate standards have been approved according to Art. 47 of the GDPR. In this case, these standards or the web address where they can be accessed shall be attached as an appendix. c) The data protection standard contractual clauses adopted by the Commission or adopted by a control authority and approved by the Commission have been signed. A copy of the signed clauses shall be attached as an annex. d) The entities carrying out the transfer of data adhere to a code of conduct or mechanism of certification, along with binding commitments enforceable by the data controller or processor in the third country to apply adequate guarantees, including those regarding the rights of the data subjects. A copy of the code of conduct or certification or website where it can be accessed shall be provided as an annex. In all other cases, international transfers of data are prohibited unless authorised by the competent control authority. X.- INFORMATION TO THE SIGNATORIES AND RESEARCH TEAM The personal data provided for the signing of the present Agreement (“Contractual Data”) and the management of the clinical Study shall be processed in accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27th April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (GDPR) and Organic Law 3/2018 of 5th December on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD). Investigator and Study Personnel’s data shall be processed by Xxxxxxx as stated in “Privacy notice for the clinical study research team” , which was provided (or will be) to Hospital/Principal Investigator and all current and future Principal Investigators, sub-investigators, and research staff. The Contractual Data shall be processed based on...
