Roles and responsibilities of the Parties. The Site and/or Principal Investigator is Data Controller for the personal data contained in the Clinical History of each project Participant. The legal basis for the processing thereof is derived from articles 6.1(c) and 9.2(h) of the GDPR. The Sponsor is Data Controller for the pseudonymised (“codified”) data in the project, which is collected via DCLs (data collection logbooks), in accordance with the project Protocol. The legal basis for the processing thereof is derived from articles 6.1(c) and 9.2(i) of the GDPR. The Sponsor may not participate in the process of collecting data from the project Participants. Therefore: The Site and/or Principal Investigator will be the parties responsible for informing the project Participants clearly, accurately and unequivocally of the processing of their personal data with relation to the Protocol, providing them, at the time when they are given the informed consent (IC), with all the information pertaining to the processing of their personal data within the framework of the research. The Site and/or Principal Investigator will be responsible for conducting the process of coding the personal data of the Participants in the clinical research, in a manner that guarantees that the information received by the Sponsor and, particularly, the content in the DCLs, may not be directly attributed to a project Participant, without access to additional information. Said additional information must be safeguarded by the Site and/or Principal Investigator. The Site and/or Principal Investigator undertake to refrain from providing information to the Sponsor and the Sponsor undertakes to refrain from receiving information that would enable them to directly or indirectly access and learn the identifying data of the Participants in the clinical research, even including the coding process used, unless this were strictly necessary in order (i) to comply with their legal obligations or those derived from the good clinical practice guidelines (e.g. auditing and/or monitoring tasks); (ii) to document, investigate or respond to adverse effect reports; and (iii) to respond to legal claims or proceedings initiated by Participants in the clinical research. Confidentiality The Parties shall ensure that all staff, including the staff of the Site and/or the Principal Investigator, as well as all members of the Research Team - who are authorised to process Personal Data have committed to fulfilling their duties of confidentiality and profession...
Roles and responsibilities of the Parties. Activities undertaken in this Agreement will involve a number of partners and implementing institutions, each of which has specific and complementary roles leading to the achievement of the Goal and Development Objectives.