2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PIBD-Net - Pediatric Inflammatory Diseases Network |
|
| Existence of an identified contact person for external enquiries | Yes | |
| Existence of an internal steering committee | Yes | The internal steering committee is composed of the 5 members of the Bureau all elected by the member of the network. The list of the governing board officers is on the PIBD-Net web site: https://www.pibd-net.org |
| Existence of an external advisory steering committee directing the reporting party | Yes | External advisory Board for the PIBDSet Quality project (REDUCE RISK, Inception cohort). The members of this board are selected between the KOL in IBD and not participating at the trial. |
| Existence of a website | Yes | https://www.pibd-net.org |
| Existence of newsletter | Yes | An electronic newsletter is sent to all RCT study participants on a regular basis. |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | The clinical study information of the 3 ongoing studies are collected through an eCRF database named RedCap. Each site will complete the eCRF with patient’s information included in the study. Only relevant information for the study will be collected. |
| Provisions to ascertain data protection and data security | Yes | Comments: PIBD-Net complies with the GCP, the EU 2016/679, national and local policies relating to data protection and patient safety. Patients could contact PIBD-Net through: dpo@pibd-net.org PIBD-Net studies have also to be GPRD compliant to obtain all regulatory approval mandatory before to start. All patient’s data are stored in a highly secured database on PIBD cloud responding to the ISO 27001 security criteria. Currently, no specific document describes this organisation. |
| Procedures to access the database by third parties | No | Currently the database is not accessible to a third party |
| Access to external databases/registries | No | |
| Standardised process to access an external database | No |