4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EPLTN - European Paediatric Liver Transplantation Network |
|
| Documented adherence to GCP guideline | Yes | The current network trial has been designed to comply with EU directive 2001/20/EC on clinical trials. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | The current project has been passed by local ethical bodies to comply with the special ethical requirements for paediatric trials in X participating sites. Final agreement of the local ethical body is still pending in Y centres. Documentation on the ethical approval of all local and/or national ethical bodies involved can be obtained via U.Baumann. |
| Documented adherence to ethical considerations | Yes | The current project has been passed by local ethical bodies to comply with the special ethical requirements for paediatric trials in all participating sites. |
| Availability of Standard Operating Procedures (SOP) | Yes | Specific SOPs have been developed in agreement with good clinical practice standards for the current network trial. Available SOPs are attached. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Monitoring according to ICH 6 Cood Clinical Practice Guideline has been implemented by the individual sites. |
| Capacity to monitor performance of collaborating centres | Yes | Trial monitoring will be provided by a clinical trials unit at the initiating site for the current network study. In the remaining sites, monitoring will be performed either by a local clinical trials unit or an external CRO as locally applicable. |
| Quality control and quality assurance, raceability and data safety | Yes | see comment to 4.6 |