Vitaccess Real MG Registry
Research type
Research Database
IRAS ID
351385
Contact name
Fatemeh Amini
Contact email
Research summary
Vitaccess Real MG Registry
REC name
Wales REC 6
REC reference
24/WA/0351
Date of REC Opinion
19 Dec 2024
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The primary objective of the registry is to build a repository of data containing relevant outcomes in MG from both patients and clinical health records. Patients will contribute custom survey and validated patient-reported outcomes data via the Vitaccess RealTM MG registry platform, which they can access on their own device (smartphone/tablet/computer/laptop). The platform will be deployed alongside a web-based electronic case report form (eCRF) platform for data capture from HCPs and existing medical records. The data provided via the eCRF and the patient will be linked via the unique ID and PIN that are created for each patient in the eCRF system prior to patient recruitment. All data collected will be identified in accordance with the protocol and validated PRO instruments and pseudonymized. All personally identifiable information (PII) will be protected by industry standard methods, ensuring full confidentiality is maintained. Registry data will be stored in secure servers, which will reduce any risk of data being compromised during storage. The infrastructure is in UK data centers and is International Organization for Standardization (ISO) 27001 and System and Organizational Controls (SOC) 1, 2, and 3 compliant. All servers are held securely behind a firewall and have been configured to current best practices. Access to the infrastructure is provided using multi-factor authentication. Software is tested for its ability to withstand outside intervention, which is validated regularly by carrying out third-party penetration testing. Database backups are carried out on a regular cycle and restore procedures are in place and tested regularly.
Research programme
Vitaccess Real MG (VRMG) is a patient registry designed to capture longitudinal observational data on myasthenia gravis (MG), its treatment, and impact on symptoms, daily activities, and quality of life (QoL). Adults (age ≥18 years) with a clinically-confirmed diagnosis of MG will be eligible to participate. The registry will link direct patient-reported data with data reported by healthcare professionals (HCPs) and from patients’ existing medical records. The purpose of the VRMG registry is to facilitate a range of research objective-driven registry-based studies to further understand the real-world impact of MG and its treatment – including the real-world pharmacoepidemiological study of novel therapies.
Research database title
Vitaccess Real MG Registry
Establishment organisation
Vitaccess Ltd
Establishment organisation address
2nd Floor Nucleus House,
2 Lower Mortlake Road,
Richmond
TW9 2JA