Dedicated data management systems are developed and configured for the data collection of all clinical studies of PRACTICE and for clinical studies in the event of an emerging epidemic that warrants response on a European scale. A number of tasks are performed to facilitate the data collection in the appropriate way:
Development of the secure electronic data capture (EDC) system that will facilitate collection, monitoring and management of data for observational studies as well as large-scale complex adaptive clinical trials.
Designing and implementing of study specific electronic CRFs onto the EDC system.
Performing user and site management. Research sites, user groups and user accounts will be implemented to the system. Users will be granted access to the platform in a role based way after they have logged-in using their personal account. The role based access to the system will avoid unauthorised data access.
Performing user acceptance testing to assure the correct implementation of the EDC system, followed by deployment of the study specific part of the EDC system to the production environment.
Implementing and maintaining a web-based application to randomise subjects for the interventional trials. Special attention will be paid to facilitate the adaptive design of randomisations for the clinical studies of WP4 and WP5.
Providing instructions and training material of the data management system to the end-users (e.g. study managers, research nurses, monitors, GPs).
Maintaining and adapting (when appropriate) all parts of the EDC system as described above during the conduct of the clinical studies in order to keep control of the correct and complete data collection. CRISP will also serve as a helpdesk for all users of the EDC system during the conduct of the studies.