Brunelin, Jerome http://orcid.org/0000-0001-5479-5628
Mondino, Marine
Haesebaert, Julie
Attal, Jerome
Benoit, Michel
Chupin, Marie
Dollfus, Sonia
El-Hage, Wissam
Galvao, Filipe
Jardri, Renaud
Llorca, Pierre Michel
Magaud, Laurent
Plaze, Marion
Schott-Pethelaz, Anne Marie
Suaud-Chagny, Marie-Françoise
Szekely, David
Fakra, Eric
Poulet, Emmanuel
Funding for this research was provided by:
Direction Générale de l’offre de Soins (PHRC2014)
Article History
Received: 22 November 2021
Accepted: 8 December 2021
First Online: 28 December 2021
Declarations
:
: The study was approved by a local ethics committee (CPP Sud Est VI, Ref AU 1231) on January 8, 2016, and by the ANSM Ref-ID-CRB: 2015-A01299-40 (French drug regulatory authority). Written, informed consent to participate will be obtained from all participants.This study will be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (Seoul 2008, revised), the ICH Guidance on Good Clinical Practices (Topic E6) (CPMP/ICH/135/95) and the European Clinical Trials Directive 2001/20/EC that provide greater protection to subjects participating in clinical trials, ensure the quality of conduct and harmonize regulation and conduct of clinical trials throughout Europe, the law N°78-17 of 06/01/1978, modified in relation to computer science, to databases and to data collection, the law 2004-806 of August 9, 2004, defines the scope of the law as all biomedical research involving human beings, with the aim of increasing biological or medical knowledge, bioethics law N°2004-800 of August 6, 2004, and General Data Protection Regulation N°2016/679.The electronic database will be declared and kept according to the criteria required by the Commission Nationale de l’Informatique et des Libertés (CNIL) (National Data Privacy Commission) and General Data Protection Regulation.
: Not applicable.
: The authors declare that they have no competing interests.