Workpackage 11

Workpackage lead and partners

Academic leader: Dr. Geraldine Boylan (UCC)

WP partners: DUKE, CLIN, GOSHFCNT

Workpackage Partners

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:

• The development of internet based online databases for managing and reporting clinical, laboratory, EEG and outcome data acquired throughout the project for all stakeholders.
• Develop clinical trial randomisation procedures.
• Develop an EEG remote monitoring platform and an EEG archiving facility for the study.
• Develop study dissemination plans

Workpackage description

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.