European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process

    Description

Name

  

BPCRN - Belgian Pediatric Clinical Research Network
Existence of an identified contact person for external enquiries Yes
Existence of an internal steering committee Yes BPCRN Steering Committee consisting of a chair and representatives from the operational team and BPCRN study sites
Existence of an external advisory steering committee directing the reporting party Yes BPCRN Advisory Board consisting of representatives from the Steering Committee, from the BPCRN sites (head of departments and SPoCs), from Flemish, Belgian and Walloon pediatric societies, from Belgian learned societies, and from patient organisations
Existence of a website Yes www.bpcrn.be
Existence of newsletter Yes Electronic newsletter distributed at least 2-4 times per year to a mailing list consisting of Belgian clinicians, research coordinators, head of departments, members of learned societies. News is also published on the website.
Existence of internal databases for disease, condition treatment and/or outcome Yes Internal and centraly stored database consisting of study site characteristics including information on available pediatric expertise (research experience, clinical expertise, networks, rare disease groups) and contact information of single point of contacts (SPoCs), head of pediatric departments and sub-SPoCs for each pediatric subspecialty. When indicated, other contact and disease-specific databases and registries are available within the centres and/or specialty areas in the network.
Provisions to ascertain data protection and data security Yes compliance with ICH-GCP and (inter)national legislation and guidelines is adhered to in all conditions
Procedures to access the database by third parties No
Access to external databases/registries Yes
Standardised process to access an external database No No direct access to external databases is possible. Upon request, the network can provide matchmaking with (inter)national databases or registries and contact learned societies and/or individual care-givers.