4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
APCTN - Antwerp Pediatric Clinical Trial Network |
|
| Documented adherence to GCP guideline | Yes | GCP-training by every researcher of the network. Since there is not yet a mission statement, it is not mentioned in other documents. |
| Documented adherence to the ethical considerations for clinical trials in children | No | Not yet |
| Documented adherence to ethical considerations | ||
| Availability of Standard Operating Procedures (SOP) | ||
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Clinical Trial Centre of the University Hospital |
| Capacity to monitor performance of collaborating centres | ||
| Quality control and quality assurance, raceability and data safety | No | Not yet |