4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PIBD-Net - Pediatric Inflammatory Diseases Network |
|
| Documented adherence to GCP guideline | Yes | Comments: All studies performed by the PIBD-Net are complying with the GCP and the EU Directive 2001/20/EC and as paediatric organisation put especially the focus on ethical consideration for clinical trials in children. Before each new study on site, the PIBD-Net clinical operation team will confirm that the medical staff is GCP trained and will during each initiation visit on site, make a GCP reminder/training. The CV of each participant at the trial has to mention the last GCP training done. Clinical operation team is trained once per year to GCP and new regulatory |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All sites and investigators participating to a PIBD-Net studies are trained to be adherent to “ethical considerations for clinical trials in children” during the initiation visit and all along the project. All studies have to obtain in each country involved, the local approval from all regulatory instance mandatory before to start. PIBD-Net retrieves all regulatory approval for site validation |
| Documented adherence to ethical considerations | Yes | Several PIBDnet Governing Board members are involved in local/national ethics committees |
| Availability of Standard Operating Procedures (SOP) | Yes | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Clinical team of PIBD-Net is able to monitor all type of trial according ICH6 GCP guideline. |
| Capacity to monitor performance of collaborating centres | Yes | The clinical project manager will routinely check the ability from sites and investigators to fulfil the SOP and GCP guidelines |
| Quality control and quality assurance, raceability and data safety | Yes | The process documents are confidential |