PAMELA - 142 patients with HER2+ breast cancer

All patients included in the trial signed this policy and the data is protected under the GDPR

All patients included in the trial signed the following data privay policy: How will the confidentiality of my medical information be protected? How will the results obtained be disclosed? Personal data, including your health data and biological samples, will be processed during the study. Both the Center and the Sponsor are respectively responsible for the processing of your data and undertake to comply with the data protection regulations in force. In particular, the processing of such shall be carried out in accordance with Regulation (EU) 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of your personal data. Your personal data will be processed for the purposes of managing your participation in the study and complying with existing legal obligations, in particular, those covered by the applicable regulations on clinical trials and biological samples. The legal basis for processing your personal data is your consent, except in those cases in which the Promoter and/or the Center must comply with any legal obligation, in which case the basis will be compliance with the legislation on clinical trials and biomedical research. Access to your clinical-healthcare data will be carried out keeping the strictest confidentiality so that your personal privacy is not violated, in accordance with the GDPR. The Researcher, when processing and treating your personal data, will take appropriate measures to protect them and prevent access to them by unauthorized third parties. The data collected for the study will be identified by a code, so that no information that can identify you is included, and only your study doctor/collaborators will be able to relate such data to you and your medical history. Therefore, your identity will not be disclosed to any other person except to health authorities, when required or in cases of medical emergency. Research Ethics Committees, representatives of the Health Inspection Authority and personnel authorized by the Sponsor may only have access to verify personal data, clinical trial procedures and compliance with good clinical practice standards (while maintaining the confidentiality of the information). Some of these recipients, whether they are service providers, scientific researchers who collaborate with us and/or entities of our Group, may be located outside the European Economic Area, in countries whose data protection regulations may not be comparable to those of Spain. However, the participant's data will be protected with safeguards such as contracts or other mechanisms by the data protection authorities. The Investigator and the Promoter are obliged to keep the data collected for the study for at least 25 years after its completion. Thereafter, your personal information will only be retained by the Center for your health care and by the Sponsor for other scientific research purposes if you have given your consent to do so, and if permitted by applicable law and ethical requirements. In accordance with the provisions of the GDPR, you can exercise your right to access, modify, oppose and delete your personal data, for which please contact your study doctor. You can also limit the processing of incorrect data, request a copy or the transfer to a third party (portability) of the data you have provided for the study. To exercise your rights, please contact the principal investigator of the study. We remind you that the data cannot be deleted even if you stop participating in the trial in order to ensure the validity of the research and to comply with legal duties and drug authorization requirements. You also have the right to contact the Data Protection Agency if you are not satisfied.