European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process



    Description

Name

 

Irish Paediatric Clinical Research Network (IPCRN) National Children's Research Centre (NCRC)

Existence of an identified contact person for external enquiries Yes info@nationalchildrensresearchcentre.org OR sinead.nally@ncrc.ie
Existence of an internal steering committee Yes Organisation chart for the steering committee will be posted on the revised website - in the meantime I have attached the committe list to the application.
Existence of an external advisory steering committee directing the reporting party No
Existence of a website Yes info@nationalchildrensresearchcentre.org The IPCRN will have its own portal, which will be accessed through the National Children's Research Centre website via: http://www.childrensresearchcentre.org/page/view/irish-paediatric-research-network
Existence of newsletter No However, the clinical data manager wishes to establish an internal disease registry, pending funding
Existence of internal databases for disease, condition treatment and/or outcome Yes info@nationalchildrensresearchcentre.org OR sinead.nally@ncrc.ie
Provisions to ascertain data protection and data security Yes All studies will be managed and conducted as per ICH GCP, the Declatation of Helsinki and the Data Protection Act (2003). The clinical data manager is in the process of organing a training session with a representative of the Data Protection Commission.
Procedures to access the database by third parties No
Access to external databases/registries No
Standardised process to access an external database No Standardised national processes for access to relevant external national databases for research