4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
CEPOETA - Central European Pediatric Oncology Early Trials Alliance |
|
| 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) | Yes | the SOPs are not published and are used only for internal needs. thea are developed via the cooperation with research infrastructure CZECRIN as national hub for ECRIN-ERIC |
| 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 |