4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ESPNIC - European Society of Paediatric and Neonatal Intensive Care medicine Research Network |
|
| Documented adherence to GCP guideline | Yes | |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | can be provided for individual centres |
| Documented adherence to ethical considerations | Yes | can be provided for individual centres |
| Availability of Standard Operating Procedures (SOP) | No | Not relevant for Network, but can be provided for individual centres |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | Not relevant for Network, but can be provided for individual centres |
| Capacity to monitor performance of collaborating centres | No | Not relevant for Network, but can be provided for individual centres |
| Quality control and quality assurance, raceability and data safety | Yes | Not for Network, but can be provided for individual centres |