4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PEDDCReN - Paediatric European Digestive Diseases Clinical Research Network |
|
| Documented adherence to GCP guideline | No | Not applicable yet but would be expected |
| Documented adherence to the ethical considerations for clinical trials in children | No | see 4.1 |
| Documented adherence to ethical considerations | No | As above |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | Not yet achieved as this is a planned future activity |
| Capacity to monitor performance of collaborating centres | No | Likely to be considered in the future |
| Quality control and quality assurance, raceability and data safety | No | Not yet achieved as this is a planned future activity |