Bottani, Simona
Thibeau-Sutre, Elina
Maire, Aurélien
Ströer, Sebastian
Dormont, Didier
Colliot, Olivier
Burgos, Ninon
,
Funding for this research was provided by:
Agence Nationale de la Recherche (ANR-10-IAIHU-06, ANR-10-IAIHU-06)
Agence Nationale de la Recherche (ANR-10-IAIHU-06, ANR-10-IAIHU-06, ANR-10-IAIHU-06)
Article History
Received: 22 May 2023
Accepted: 7 March 2024
First Online: 20 March 2024
Declarations
:
: The AP-HP obtained the authorization of the CNIL (Commission Nationale de l’informatique et des Libertés, the French regulatory body for data collection and management) in 2017 to share data for research purposes in compliance with the MR-004 reference methodology [CitationRef removed] (authorization №1980120). The MR-004 reference (ExternalRef removed) controls data processing for the purpose of studying, evaluating and/or researching that does not involve human persons (in the sense of not involving an intervention or a prospective collection of research data in patients that would not be necessary for clinical evaluation, but which allows retrospective use of data previously acquired in patients). The goals of the clinical data warehouse are the development of decision support algorithms, the support of clinical trials and the promotion of multi-center studies. According to French regulation (i.e., the MR-004), and as authorized by the CNIL, patients’ consent to use their data in the projects of the CDW can be waived as these data were acquired as part of the clinical routine care of the patients. At the same time, AP-HP committed to keep patients updated about the different research projects of the clinical data warehouse through a portal on the internet (ExternalRef removed) and individual information is systematically provided to all the patients admitted to the AP-HP. In addition, a retrospective information campaign was conducted by the AP-HP in 2017: it involved around 500,000 patients who were contacted by e-mail and by postal mail to be informed of the development of the CDW. The project on which the proposed work is based is called APPRIMAGE, it is led by the ARAMIS team (current AP-HP PI: Didier Dormont; initial AP-HP PI: Anne Bertrand, deceased March 2nd 2018) at the Paris Brain Institute and it was approved by the Scientific and Ethics Board of the AP-HP (IRB00011591) in 2018 [CitationRef removed]. All methods were performed in accordance with the relevant guidelines and regulations.
: Not applicable.
: The authors declare no competing interests.