4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EBMT PDWP - European Blood and Marrow Transplantation Paediatric Diseases Working Party |
|
| Documented adherence to GCP guideline | Yes | as referring to the clinical trials yes |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | |
| Documented adherence to ethical considerations | Yes | close cooperation with ethics committees, cooperation with parent's initiatives |
| Availability of Standard Operating Procedures (SOP) | Yes | go to JACIE website |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | yes partly; e.g. in the ALL SCTped study as a clinical trial. In retrospective trials mostly plausibility checks |
| Capacity to monitor performance of collaborating centres | Yes | yes on academic level |
| Quality control and quality assurance, raceability and data safety | Yes |