THE DINEMO STUDY : PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND OUTCOMES IN NMOSD: REAL-WORLD DATA FROM NOMADMUS COHORT
Objectif(s) de la recherche et intérêt pour la santé publique
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
This study aims to provide data on the characteristics of NMO or NMOSD patients, the therapeutic strategies implemented, and the evolution of patients’ disability and disease activity, based on data from the French NOMADMUS cohort... . The primary objective for this activity is as follows:. . • To describe the demographic, clinical, and biological characteristics of NMOSD patients, at the diagnosis of the disease and at the last assessment.. . The secondary objectives for this activity are as follows:. . • To describe the therapeutic strategies implemented in NMSOD patients. . • To describe the evolution of the patient disability and the disease activity.
Données utilisées
Catégories de données utilisées
Source de données utilisées
Variables sensibles utilisées
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Responsable(s) de mise en oeuvre non cités comme responsable de traitement
Responsable de mise en oeuvre non cité comme responsable de traitement 1
Calendrier du projet
Base légale pour accéder aux données
Durée de conservation aux fins du projet (en années)
1
Fondement juridique
Article 6 du RGPD (Licéité du traitement)
Article 9 du RGPD (Exception permettant de traiter des données de santé)
Transfert de données personnelles vers un pays hors UE
Droits des personnes
The collection, conservation and management of the OFSEP database are placed under the legal and administrative responsibility of the EDMUS Foundation, which is in particular responsible for the formalities to be carried out in order to comply with the terms of the law "Informatique et libertés modifiées" and the general regulation on data protection (RGPD) as well as those of the Public Health Code.. . The EDMUS Foundation :.. have all the required authorizations including in particular the authorizations necessary for the processing of personal data,.. Authorizes the OFSEP Partners to process the Data Set for the conduct of the Study... . The OFSEP Partners guarantee that they have the exclusive rights to use the OFSEP database, allowing them to carry out analyses from the OFSEP database.. . The OFSEP Partners warrant that the patients whose data make up the Data Set have been informed of the purpose of the processing carried out by Roche under the Study in accordance with the procedures and documents validated jointly between Roche and the OFSEP Partners and that these persons have not objected to the use of their data in the Study.. . For this purpose, the OFSEP Partners will add a page dedicated to the DiNeMO study on the OFSEP website. This page will present the objectives of the Study and the treatment performed. This patient information will indicate how the Patient can object to the processing of his/her personal data.