RePaRe (Regeneten Patient Registry)
Objectif(s) de la recherche et intérêt pour la santé publique
Finalité de l'étude
Objectifs poursuivis
Domaines médicaux investigués
Bénéfices attendus
The objective of this registry is to collect real-world evidence for evaluation of the clinical, health economic and patient reported outcomes following rotator cuff repair using the REGENETEN Bioinductive Implant in a post-market, observational data capture project.
Patients who are listed to undergo a surgical rotator cuff repair procedure who are deemed suitable for a REGENETEN Bioinductive Implant, as per the Clinician’s standard of care, will be invited to participate in the Registry. The protocol demands no treatment allocation nor prescription of interventions or procedures.
Données utilisées
Catégories de données utilisées
Autre(s) catégorie(s) de donnée(s) utilisée(s)
enrolment, demographics, medical history, operative data, Patient shoulder function and quality of life (QoL), Post-operative recovery determined by assessing sling wear-time, return to driving, work or sport, number of physiotherapy visits, duration of narcotic pain therapy and number of injections required, Re-tear rate, Revision rate
Source de données utilisées
Autre(s) source(s) de donnée(s) mobilisée(s)
Appariement entre les sources de données mobilisées
Plateforme utilisée pour l'analyse des données
Acteurs finançant et participant à l'étude
Responsable(s) de traitement
Type de responsable de traitement 1
Responsable de traitement 1
Localisation du responsable de traitement 1
Représentant du responsable de traitement 1
Calendrier du projet
Base légale pour accéder aux données
Encadrement réglementaire
Durée de conservation aux fins du projet (en années)
5
Existence d'une prise de décision automatisée
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
The Sponsor is in the UK but will have access to anonymized data, patient information will not be disclosed from sites to the Sponsor. In any case, it is covered by rhe EU-U.S. DPF, UK Extension to the EU-U.S. DPF, and Swiss-U.S. DPF that were respectively developed by the U.S. Department of Commerce and the European Commission, UK Government, and Swiss Federal Administration to provide U.S. organizations with reliable mechanisms for personal data transfers to the United States from the European Union, United Kingdom, and Switzerland while ensuring data protection that is consistent with EU, UK, and Swiss law.
Droits des personnes
Right of Access (Article 15): Individuals have the right to obtain confirmation from the data controller as to whether their personal data is being processed, and if so, access to that data along with information about the processing purposes, categories of data, recipients, and more.
Right to Rectification (Article 16): Individuals can request the correction of inaccurate personal data and the completion of incomplete data.
Right to Erasure (Article 17): Also known as the "right to be forgotten," this allows individuals to request the deletion of their personal data under certain conditions, such as when the data is no longer necessary for the purposes it was collected.
Right to Restriction of Processing (Article 18): Individuals can request the restriction of processing of their personal data in specific situations, such as when they contest the accuracy of the data or object to the processing.
Right to Data Portability (Article 20): This right allows individuals to receive their personal data in a structured, commonly used, and machine-readable format, and to transmit that data to another controller without hindrance.