4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
POLPEDNET - Polish Network of Clinical Trials in Paediatrics |
|
| Documented adherence to GCP guideline | Yes | Each site have own internal regulations |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Each site have own internal regulations |
| Documented adherence to ethical considerations | Yes | CTIS system is ongoing |
| Availability of Standard Operating Procedures (SOP) | No | Each site have own internal regulations |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Each site have own internal regulations and staff managed for such actions |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | Yes | Each site have own internal regulations |