DATA PROTECTION. Data Processing Activities The Parties shall process the Personal Data in accordance with the provisions of the study Protocol and the applicable data protection regulations, particularly: the General Data Protection Regulation, Regulation 2016/679 (EU) of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (“GDPR”), and Organic Law 3/2018 of 5 December on Personal Data Protection and the guarantee of digital rights (“LOPDGDD”) and any other Spanish regulations on information security that are applicable (hereinafter “applicable Data Protection regulations”). The Sponsor is an entity that subscribes to the Farmaindustria Standard Code on Personal Data Protection in Clinical Research and Pharmacovigilance, and is obliged to comply with the provisions contained therein. The Parties, as Data Controllers, understand and accept their respective obligations and responsibilities with regard to the study Protocol, which establishes the subject, duration, nature and purposes of data processing within the study, as well as the categories and type of data processed (“study Participants”), and the applicable Data Protection regulations, according to the extent of their participation and responsibility in the processing thereof. The obligations of each Data Controller do not eliminate or substitute their respective obligations with respect to the Agreement and the applicable Data Protection regulations.
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Sources: Observational Study Agreement, Observational Study Agreement
DATA PROTECTION. Data Processing Activities The Parties shall process the Personal Data in accordance with the provisions of the study Trial Protocol and the applicable data protection regulations, particularly: the General Data Protection Regulation, Regulation 2016/679 (EU) of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (“GDPR”), and Organic Law 3/2018 of 5 December on Personal Data Protection and the guarantee of digital rights (“LOPDGDD”) and any other Spanish regulations on information security that are applicable (hereinafter “applicable Data Protection regulations”). The Sponsor is an entity that subscribes to the Farmaindustria Standard Code on Personal Data Protection in Clinical Research and Pharmacovigilance, and is obliged to comply with the provisions contained therein. The Parties, as Data Controllers, understand and accept their respective obligations and responsibilities with regard to the study Trial Protocol, which establishes the subject, duration, nature and purposes of data processing within the studyTrial, as well as the categories and type of data processed (“study Trial Participants”), and the applicable Data Protection regulations, according to the extent of their participation and responsibility in the processing thereof. The obligations of each Data Controller do not eliminate or substitute their respective obligations with respect to the Agreement and the applicable Data Protection regulations.
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