Pricci, Flavia http://orcid.org/0000-0002-1877-4376
Rotondi, Daniela
Villa, Marika http://orcid.org/0000-0003-2944-5444
Valerio, Arianna
Agazio, Elvira
Roazzi, Paolo
Article History
Received: 20 May 2021
Accepted: 11 February 2022
First Online: 3 March 2022
Declarations
:
: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.The data collection procedures from clinical units to the RNAOC are in agreement with the Italian legislation for the personal data protection (Legislative Decree 196/2003) and have been updated according to the current European regulation (General Data Protection Regulation, GDPR 2016/679).This observational study is included in the Register of Data Treatments of the National Institute of Health (Istituto Superiore di Sanità ).Informed consent is not required because processing personal data is essential in order to carry out surveillance activities and drug reimbursement. Anyway, to ensure compliance with the GDPR, an information notice for patients is available in the RNAOC-web platform, with the description of personal data treatment in terms of objective, methods, and ownership. For the retrospective study, formal consent is not required.
: Not applicable.
: The authors declare that they have no conflict of interest.