4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
I-BFM-SG - International BFM Study Group |
|
| Documented adherence to GCP guideline | Yes | All studies conducted since 2006 (Interfant-06, AIEOP-BFM ALL 2009;ICC APL Study 01) fully adhere to the GCP guideline. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | The approval of the study is done at national levels, according to the different bylaws but including the most recent EU directive on Ethical considerations for clinical trial in paediatric populations. |
| Documented adherence to ethical considerations | Yes | All National ECs include paediatric expertise. |
| Availability of Standard Operating Procedures (SOP) | Yes | Only the most recent clinical studies (see above 4.1) include SOPs. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Only the most recent clinical studies (see above 4.1). |
| Capacity to monitor performance of collaborating centres | Yes | The perfomance of the collaborating centres is monitored through the National Study Groups. |
| Quality control and quality assurance, raceability and data safety | Yes | The merged steering Committees of the different National Study Group is fully responsible of the quality control and quality assurance. An independent DMSC has become common policy of the most recent clinical studies performed by the network. |