European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management



    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