2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RIPPS - Réseau d'Investigation Pédiatrique des Produits de Santé Service de Pharmacologie Clinique (Hôpital Saint Vincent de Paul Groupe hospitalier Cochin – Saint Vincent de Paul) |
|
| Existence of an identified contact person for external enquiries | Yes | A single contact (info@ripps.eu) to mobilize the all members of the coordination unit. Members of coordination unit : Gérard Pons and Behrouz Kassai (coordinators), Catherine Chiron, Claire Cacherat, Brigitte Ravis , Jean-Francois Oudet, Etienne Javouhey, Salma Malik (conatct person for external enquiries), Myriam Benyoub (secretary ripps) A single expert for each speciality covered by the network : Epilepsy : P. Berquin (Perene Network) Handicap : V. Desportes (DéfiScience Network) Neuromuscular disease : C. Bérard (RMNMI RA) Autism : S. Magnificat |
| Existence of an internal steering committee | Yes | Management Board that meets quarterly to review strategic direction, recruitment to studies, training and finances. |
| Existence of an external advisory steering committee directing the reporting party | Yes | It include the coordinator of each partner networks : Epilepsy : P. Berquin (Perene Network) Handicap : V. Desportes (DéfiScience Network) Neuromuscular disease : C. Bérard (RMNMI RA) |
| Existence of a website | Yes | www.ripps.eu Website with two spaces : - Intranet with limited access for partners and members. Documents specific to the group may be consulted. A dedicated space for each networks' partner - Extranet (french):description of the actuality of RIPPS + Existence of a single contact point (info@ripps.eu) to interact with the RIPPS Website with two spaces : - Intranet with limited access for partners and members. Documents specific to the group may be consulted. A dedicated space for each networks' partner - Extranet (french):description of the actuality of RIPPS + Existence of a single contact point (info@ripps.eu) to interact with the RIPPS |
| Existence of newsletter | Yes | In progress However, Email list of all members maintained by secretariat and used to distribute relevant information, agendas for meetings etc |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | Database of all studies/clinical trials in preparation, on going or completed is maintained. This holds information regarding recruitment and is updated quarterly. |
| Provisions to ascertain data protection and data security | Yes | all patients' and study participants' data are secured on two storage spaces. Patients data are secured with password to allow only restricted access. Data are handled by partners of RIPPS (Medsharing, Clininfo) Compliant with data protection act GCP and French drug Agency (FDA) |
| Procedures to access the database by third parties | Yes | Clininfo and Medshearing are implicated in all trials. Access to this database are stored on a virtual space accessible by login and password. |
| Access to external databases/registries | Yes | With ethical permission (which is study specific), access is possible to a range of relevant databases |
| Standardised process to access an external database | Yes | Depending of the data base : Access to the data base is only upon request after precise definitions of the hypothesis, objectives, plan of analysis of the data. |