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Article History

Received: 5 September 2020

Accepted: 2 March 2021

First Online: 1 April 2021

Declarations

:

: According to the French regulation, the calibration of a PROM instrument falls into a specific research category that does not require the approval of an ethics committee, but a formal declaration to the French Data Protection Authority (CNIL) which was officially recorded on August 17, 2017.(1) The regulatory procedure that applies to this research category requires (i) a detailed patient information about the research and (ii) a non-opposition statement from the patient in order to use personal data for scientific purpose. This two-step process was secured through the digital platform where patient’s information and non-opposition were automatically administered before granting access to the Catquest-9SF questionnaire. Data pseudonymization was also automatically performed to comply with General Data Protection Regulation. (1) The CNIL declaration was registered under the number #2219673.

: Not applicable.

: The authors declare that they have no competing interests.