4 - Quality management
Quality
Management |
Training and
Education |
Public
Involvement |
Description | ||
---|---|---|
Name |
GNN - German Neonatal Network |
|
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) |
Yes | |
Capacity to monitor performance of collaborating centres | Yes | |
Quality control and quality assurance, raceability and data safety | Yes |