Declaration to the competent authorities
ADVERSE EVENT, ADVERSE REACTION
The sponsor assesses the causal relationship between the serious adverse event and the research. The sponsor shall report to the French Competent Authority (ANSM), any serious adverse reaction and serious incident, expected and unexpected that occurs in France and outside the national territory, during the research without delay. For reporting to the competent authority, SAE will be coded according to the MedDRA classification.To ensure completeness of the safety data, the sponsor will work with local correspondent for biovigilance from the centers participating in the study.An annual safety report will be submitted to the Ethic Committee and the Competent Authority (ANSM) by the sponsor within 60 days of the anniversary date of the study.Any new issue related to the research and likely to undermine the safety of patients participating to the study will lead to urgent safety measures and information without delay by the sponsor to the competent authority and to the Ethic Committee.