Work involving data bases of human information, electronic, genetic or other information must adhere to the law laid down in the European directive 95/46 CE and will also follow the law no 78-17 from the 6th January 1978 (modified law 94-548, on the 1st July 1994, decree no 78-774, from the 17th July, 1978, modified, decree no 95-682 from the 9th May, 1995).
Appropriate measures will be taken to ensure that data protection, confidentiality and anonymity are maintained by the NEMO partners. Local, national and international rules covering data protection will be strictly followed. This activity will be ensured through the activity of WP 05 and WP 11. All data will be stored in encrypted and pass-word locked files, whilst transmission of information via electronic means will be performed using encrypted data files.
NEMO data will be secured according to national and European regulations: names will not be listed nor any set of demographic data which would allow identification of specific participants. Disclosure of information from the study to third parties will be limited to those undertaking legitimate peer review of the scientific and ethical aspects of the study, co-workers and parents/guardian (only their own data), so that consent can be obtained and medical care provided. High priority will be assigned to participant confidentiality and welfare. Parents and guardians will be permitted to request removal of the coded data from the study and this will be stated in the NEMO consent form.
A Data Monitoring Committee (DMC) has also been established which consists of 4 independent experts from outside the NEMO consortium who will oversee study monitoring and safety of the NEMO study. The coordinator and the co-coordinator confirm that they will report to the Commission before the commencement of trials in all participating centres. Although independent from each other, the Data Monitoring Committee will report regularly to the ethics advisory group as well as to the sponsor. The DMC will submit annual reviews on data safety to the European Commission. Their main objective is to ensure that the safety of the newborn infant (both short-term and long-term) is always the main priority of the NEMO study and that clinical trial design conforms to ICH-GCP guidelines.
Prof. Richard Cooke
Professor of Neonatology, University of Liverpool, Liverpool, UK
Professor of neonatal medicine at the Liverpool Women's Hospital
Neonatal neuro-imaging, long-term follow-up studies of preterm infants, neonatal biochemistry and genetics
Prof. Henry Haliday
Retired consultant Neonatologist
Honorary Professor of Child Health, University of Belfast, Northern Ireland, UK
Neonatal respiratory disorders, randomised clinical trials, systematic reviews, social deprivation in pregnancy, respiratory distress syndrome, neonatal chronic lung disease
MOMENTS study. R&D Office.2003-2006
TOBY study. MRC.2003-2007
BOOST 2 study. MRC.2006-2009
Dr. Mark Turner
Senior Lecturer in Neonatology
Department Reproductive and Developmental Medicine at the University of Liverpool, UK
Clinical drug development in neonates, High quality medicines for children, Women's Health (neonatal follow-up)
Mr. Ed Juszczak
Head of Trials at the National Perinatal Epidemiology Unit (NPEU) Clinical Trials Unit , University of Oxford
Design, conduct, analysis and reporting of RCTs, with a particular interest in multi-arm trials and the use of statistics in the areas of mental health, neonatology, paediatrics and surgery