4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
JSWG of PRES - Juvenile Scleroderma Working Group of the Pediatric Rheumatology European Society |
|
| Documented adherence to GCP guideline | Yes | |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | |
| Documented adherence to ethical considerations | Yes | |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | |
| Capacity to monitor performance of collaborating centres | Yes | |
| Quality control and quality assurance, raceability and data safety | Yes |