The European Paediatric Neurology Society (EPNS) is an international medical society dedicated to the promotion of clinical care and scientific research in the field of paediatric neurology. The society focuses on the advancement of the field as both a discipline and a profession.
The needs of EPNS
To evaluate the clinical, metabolic and cognitive evolution of children with epileptic seizures, EPNS sought to collect patient data in a registry. The associated research, spanning all European Union (EU) countries, registers patients that have a seizure before the age of 1 year. It includes follow-up, treatment, and cognitive and motoric development by using the Denver test. The registry started in January 2012, with a pilot project (± 5 centers, ±50 patients) in May 2011. For this research protocol, EPNS required an electronic patient registry to collect patient data. This included electronic case report forms (eCRFs) for an inclusion visit, and three follow-up dates.
The EPNS registry
UniWeb developed, implemented, and hosts a secure online registry to collect data for the EPNS epileptic patient registry through a standard web browser. The data is collected through eCRFs, developed by our team, derived from the final questionnaire provided by EPNS. The registry system is designed with user friendly data entry screens to facilitate the collection of patient information onto the eCRFs. Data entry follows specific input validation rules as defined by the client. The edit check plan is enforced by a system of alerts that enables investigators to perform validation checks, and allows sponsors and data managers to trace and close the checks. A data export function is available for downloading data into excel files.
UniWeb provides secure hosting on a dedicated server and restricted access at different levels depending on profile permissions. All data transfers are 256 bit encrypted.
Registries require a robust yet user-friendly system to facilitate collection of patient data. The EPNS registry meets the industry-specific needs of these patient registries. The feature-rich system is flexible and easy-to-use while providing built-in 21 CFR Part 11 and regulatory compliance.
UniWeb provides EPNS with its UniCare services which offers the client security screening and updates, repair of software/system errors, routine checks, and a 24/7 helpdesk. EPNS also has access to user support.