Academic leader: Dr. Geraldine Boylan (UCC)
WP partners: DUKE, CLIN, GOSHFCNT
The overall aim of this workpackage is to provide the infrastructure and platform for data management, monitoring and dissemination throughout the NEMO study. This will require the following specific tasks:
This work package in the NEMO study is essential for the day to day management and monitoring activities of this research study, which will by its very nature require a large amount of data management. Data from the clinical trial including large EEG data files must be stored and archived, regular reports must be generated and in addition, data from the neurodevelopmental trial at two years must also be stored and reconciled with the clinical trial records. The data storage system required will be large and must have web-based functionality to allow study investigators from all the participating centres to interact with the system as seamlessly and efficiently as possible.
Clininfo will provide the online clinical data management system which will include a web-based multilingual electronic case report form (eCRF) for online data entry and dynamic randomisation procedures.
The Boole Centre for Research in Informatics (BCRI) at University College Cork are developing a web based remote EEG monitoring platform for all study sites and this platform with be seamlessly linked with the clinical data management system.