4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
SwissPedNet - Swiss Research Network of Clinical Pediatric Hubs |
|
| Documented adherence to GCP guideline | Yes | Link to documentation of organisation: https://www.swisspednet.ch/header/about-us/organisation --> quality policy frequency of training: at least every 2 years |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Link to documentation of organisation: https://www.swisspednet.ch/header/about-us/organisation --> quality policy |
| Documented adherence to ethical considerations | Yes | pediatric experts are part of cantonal ethic committees |
| Availability of Standard Operating Procedures (SOP) | Yes | Each study site has their own QMS |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Directly by the members of SwissPedNet or by collaborating CTUs of the Swiss Clinical Trial Organisation |
| Capacity to monitor performance of collaborating centres | Yes | In responsibility of the Sponsor |
| Quality control and quality assurance, raceability and data safety | Yes | Link to documentation of organisation: https://www.swisspednet.ch/header/about-us/organisation --> quality policy |