4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PCIC - Pediatric Clinical Investigation Center, Belgium |
|
| Documented adherence to GCP guideline | Yes | Alla study procedures are compliant with ICH-GCP.Each member of our staff has a CGP certificate |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All clinicals trials must have been approved by our Ethics Committee before starting. Our paediatric Clinical Investigation Center respects the recommandations of our Ethics Committee. Our study procedures and quality system are adapted to comply with ethical requirements for paediatric trials. |
| Documented adherence to ethical considerations | Yes | |
| Availability of Standard Operating Procedures (SOP) | Yes | We have a quality system of the clinical research in our hospital.All procedures are reveiwed and updated . |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | On-site source date verification could be performed by our staff (but no ongoing trials to monitor at the moment).Study monitoring of industry sponsored trials is monitoring according to ICH-GCP |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | Yes | We have implemeted a quality system for the clilical research in the hospital. We received the full acreditation from the AAHRPP (Association for the Accreditation of Human Research Protection Program ) |