Funding for this research was provided by:
Consortium Value-Based Health Care, France
Received: 5 September 2020
Accepted: 2 March 2021
First Online: 1 April 2021
: 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.