Association sans but lucrative
RCS Luxembourg F1819
6, Avenue Guillaume
L-1650 Luxembourg
Contact: info@rettsyndrome.eu
- Overview
- Data model
- Collected data
- Backoffice CRUD
- Longitudinal Data
- Survey Management
- File Upload
- User Management
- Reporting and Analytics
- Security and Compliance
- Auditing
- Consent Management
- Mobile use cases
- Technical implementation
The European Rett Syndrome Patient Registry Project aims to create a comprehensive registry for Rett Syndrome patients, providing a centralized repository of clinical and genetic information to support research, healthcare, and policy development. This initiative is designed to complement existing European Rett Syndrome databases, filling in key gaps to advance research, improve care, and facilitate future clinical trials.
The registry is managed by Rett Syndrome Europe (RSE) and adheres to the strict data protection standards set forth by GDPR.
Objective: To fill existing gaps in European Rett databases, particularly in areas not covered by clinical trials and registries developed by healthcare professionals.
Rationale: While clinical trial registries provide valuable data, they do not always capture real-world patient experiences, variations in treatment, or comprehensive demographic information. This registry will collect additional data that is critical for improving understanding and care.
Objective: To provide a secure, GDPR-compliant platform for collecting and sharing anonymized patient data across Europe.
Rationale: Research into Rett Syndrome is often fragmented across countries. By establishing a cross-border registry, we aim to provide researchers, clinicians, and policymakers with a unified source of information to support research and clinical trial readiness.
Objective: To provide families, caregivers, and healthcare professionals with insights into common trends, treatment effectiveness, and demographic data that can improve patient care across Europe.
Rationale: Collecting real-world data on treatment outcomes and the lived experience of patients with Rett Syndrome can help improve treatment protocols and care guidelines.
Objective: To ensure all personal data, including sensitive medical information, is collected, stored, and processed in full compliance with GDPR, including the use of secure, encrypted infrastructure.
Rationale: Protecting patient privacy is of the utmost importance, especially when dealing with medical information. The registry will use GDPR-compliant tools and processes to ensure data is protected at all times.
The data collected by the European Patient Registry will include, but is not limited to, the following categories:
- Demographic Data: Age, gender, country of residence, etc.
- Genetic Information: MECP2 mutation status, other genetic markers as available.
- Medical History: Relevant medical conditions, comorbidities, treatments received, etc.
- Caregiver Information: Primary caregivers and legal guardianship details (as needed for research purposes).
All data will be collected with the explicit consent of the patients or their legal guardians, and the purpose for which the data is collected will be clearly communicated to participants.
Access to the data collected in the registry will be limited to authorized personnel, as defined below:
- Authorized Personnel: Only designated researchers, clinicians, and project administrators will have access to the non-anonymized data. Their access will be logged and monitored to ensure accountability.
- Data Sharing: Anonymized, aggregated data will be made available for approved research projects, subject to ethical review and compliance with GDPR.
- Security Measures: All data will be encrypted both in transit and at rest, and stored on secure servers that meet GDPR, ISO 27001, and NIST compliance standards.
To ensure the privacy of participants, all sensitive information will be anonymized before sharing with researchers. The following anonymization processes will be implemented:
- Data Pseudonymization: Personal identifiers such as names, addresses, and contact information will be replaced with unique codes that cannot be traced back to individuals without the use of a separate key, which will be stored securely and separately.
- Encryption: All sensitive data will be encrypted using industry-standard protocols both in transit and at rest.
We are currently collaborating with key organizations to ensure the success and compliance of this project.
We are also keen to involve additional stakeholders who share our commitment to advancing Rett Syndrome research in a responsible and compliant manner.
The European Patient Registry Project is designed to complement existing databases and provide critical data for research, care, and clinical trials. We are committed to ensuring the highest standards of data protection and compliance throughout the project.
We welcome feedback and collaboration to further refine our objectives and processes, and we remain open to discussions with experts and stakeholders to ensure the project's success.