4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
conect4children - Collaborative Network for European Clinical Trials for Children (c4c) |
|
| Documented adherence to GCP guideline | No | In development |
| Documented adherence to the ethical considerations for clinical trials in children | No | In development |
| Documented adherence to ethical considerations | No | In development |
| Availability of Standard Operating Procedures (SOP) | No | In development |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Responsibility of Sponsor. In the case of the non-Industry PoV studies this will be INSERM, OPBG, and UCL |
| Capacity to monitor performance of collaborating centres | No | In development |
| Quality control and quality assurance, raceability and data safety | No | In development |