2.17. Ethics and dissemination
Organic Law
The study protocol (Version 8 – March 2, 2023) was approved by the local Institutional Review Board of the Bellvitge University Hospital (Barcelona, Spain) (Ethics and Clinical Investigation Committee, code PR129/22, on March 9, 2023).This Trial will be conducted according to the criteria set by the Declaration of Helsinki (revised on WMA 64th General Assembly, Fortaleza, Brazil, October 2013), Good Clinical Practice standards and applicable regulations. Every patient that accepts to participate will be requested to sign a written informed consent prior to initiating any research activities.Furthermore, patients must be informed that their participation in this research is entirely voluntary, and that they can withdraw at any time, under no penalty risk whatsoever. Investigators’ participation in this study is free, voluntary, unpaid, and independent.The level of confidentiality protection, in terms of personal data protection, as required by Spanish Law (Organic Law on Data Protection 3/2018), was also ensured. Every patient that accepts to participate in the study will be assigned consecutive numbers as they are enrolled, and these numbers (or codes) will be used in the eCRF, instead of personal data. The data collected will be encoded, so that the patient to whom they correspond is not identified.