INCiPiT is glad to announce that it has obtained a favorable opinion from the DPO for the use of retrospective data related to the RESPIRIAMO Study, of which it is the Sponsor.

The RESPIRIAMO Study aims to conduct surveillance for lower respiratory tract infections (LRTIs), paying particular attention to those caused by the Respiratory Syncytial Virus (RSV).

The Study includes a prospective surveillance phase (currently on-going), with the enrollment of 355 children, aged between 0 and <2 years, hospitalized for LRTI for less than 72 hours and a retrospective surveillance phase which involves the enrollment of 1665 patients with the same characteristics. Retrospective surveillance will use data from the seasonal periods from 2018 to 2021.

Pursuant to art. 110 of the GDPR and following the favorable opinion of the Ethics Committees of the centers involved in the study, in June 2023 INCiPIT had requested a consultation of the DPO to use the retrospective data of the 2018/2019, 2019/2020 and 2020/2021 seasons requesting an exemption from obtaining the informed consent of the aforementioned patients.

This favorable opinion represents an important milestone in the current and future management of Clinical Trials. Find enclosed the protocol and synopsis of the study and information on the processing of personal data (pursuant to art. 14 of EU Regulation 2016/679).

INCiPiT – Italian Network for Pediatric Clinical Trials

20240219_informativa standard Sperimentazioni art. 14_Studio RESPIRIAMO_INCIPIT

02_RESPIRIAMO_Synopsis_it_V3.0 13Oct2022

INC_RESP_003_Respiriamo_INCiPiT format_Protocol_V3.0_en_dated 13Oct2022_final_clean