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 | SwissPedNet Quality Policy, see http://www.swisspednet.ch/about-us/organization/ |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | SwissPedNet Quality Policy, see http://www.swisspednet.ch/about-us/organization/ |
| Documented adherence to ethical considerations | Yes | SwissPedNet Quality Policy, see http://www.swisspednet.ch/about-us/organization/ |
| Availability of Standard Operating Procedures (SOP) | Yes | The Clincial Pediatric Hubs adopt the QMS of their local CTU regarding general GCP adherence. Site specific SOPs are available locally, pediatric specific SOPs are in development. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Infrastructure available within the CTU network. |
| Capacity to monitor performance of collaborating centres | Yes | As of 2017 an auditor pool is available for academic researchers and sites. |
| Quality control and quality assurance, raceability and data safety | Yes | Part of the QMS. Partly still in development. |