European Medicines Agency - Regulatory - Regulation of medicines

2 - Network organisation and process

    Description

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PEDSTART - French national paediatric research network

Existence of an identified contact person for external enquiries Yes Pr Regis Hankard and Severine Wack (Project manager) at pedstart@inserm.fr
Existence of an internal steering committee Yes Composed by the network's coordination team, a F-CRIN/Inserm representative, a C4C representative (involved in WP), 2 pediatricians, a pharmacology expert and representatives from SIOPE and IMAGINE PEDSTART coordinators: Régis Hankard and Frédéric Gottrand (Lille) INSERM/ F-CRIN representative: Dr Claire Levy-Marchal Quality control c4c member/ coordinator of RIPPS: Berhouz Kassai (Lyon) Project managers: Séverine Rochaud and Maya Patel CIC coordinators: Mireille Castanet (Rouen), and Jean-Pierre Salles (Toulouse) Clinical pharmacology expert : Evelyne Jacqz-Aigrain (Robert Debré-Paris)` IMAGINE representative: Jean-Marc Treluyer (Necker Enfants malades- Paris) SIOPE representative: Gilles Vassal This information will be available on the PEDSTART website.
Existence of an external advisory steering committee directing the reporting party Yes An external scientific committee exists, with a meeting every year. A general charter for the PEDSTART network is currently under review, and it includes an advisory board members list. The members are those of the steering committee and representatives of YPAG, patient’s association, French paediatrics society, CRO, Industry, and c4c. It also includes the head of paediatric clinical Investigation units from the other member sites and representatives of RIPPS and HUGOPEREN networks. This information will be available on the PEDSTART website.
Existence of a website www.pedstart.fr Description of the PEDSTART missions and news, available by the public. Existence of a single contact point (pedstart@inserm.fr) to interact with the PedSTART Network
Existence of newsletter Yes Steering Committee minute is disseminated every month, including the latest relevant informations for the network’s members. A more widespread Newsletter aiming at consolidate PEDSTART’s activities and teamwork is currently being developed. PEDSTART website could be a tool for its dissemination through a newsfeed.
Existence of internal databases for disease, condition treatment and/or outcome Yes As PEDSTART is a F-CRIN- labelled network, OLGA database is currently used for the general network activities (projects, submission calls, financial data, academic or industrial trials...). It does not include patient’s data. It is managed by the coordination team of the PEDSTART network. Data regarding diseases and treatment are available in the databases of all the affiliated CICs and are updated on regular basis. Further, the COVID crisis made us building a general population database on paediatric population (COVIREIVAC enfants)
Provisions to ascertain data protection and data security Yes As required by the French Authorities, patients and participants data are protected at several levels in each centres. The CIC members are all university hospitals with specific data records protection and secured with passwords to allow only restricted access For patients data: compliant with data protection act As belonging to the INSERM, PEDSTART is GDPR-compliant.
Procedures to access the database by third parties No
Access to external databases/registries Yes Standardized processes are used at national level for access to relevant external national databases for research (with ethical permission, which is study specific).
Standardised process to access an external database Yes Standardized processes are used at national level. Depending on the database: access to the database is only upon request after precise definitions of the hypothesis, objectives and plan of analysis of the data.