European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

Red SAMID - Spanish National Obstetric and Paediatric Research Network

Existence of an identified contact person for external enquiries Yes Máximo Vento Torresr, Project Leader and coordinator Aitor Teneria Yañez, Project manager
Existence of an internal steering committee Yes six key members 1.Maximo Vento 2.Oscar García 3.Fernando Cabañas
Existence of an external advisory steering committee directing the reporting party Yes
Existence of a website Yes www.redsamid.net
Existence of newsletter Yes www.redsamid.net
Existence of internal databases for disease, condition treatment and/or outcome Yes for VLBW infants: information on perinatal risk factors, neonatal interventions and short and long term outcomes
Provisions to ascertain data protection and data security Yes Data is submitted to the central office anonymously for patient and unit identities. Unique code and encrypted database are used. the database items, definitions and all protection and security precesses were possitibly evaluated by http://www.agpd.es/portalwebAGPD/index-ides-idphp.php Mirror Servers are used
Procedures to access the database by third parties Yes
Access to external databases/registries No
Standardised process to access an external database No