4 - Quality management
Quality
Management |
Training and
Education |
Public
Involvement |
Description | ||
---|---|---|
Name |
c4c-S - conect4children Stichting |
|
Documented adherence to GCP guideline | Yes | All staff is trained on ICH GCP every two years The network has developed a paediatrics GCP course available for all within the network. |
Documented adherence to the ethical considerations for clinical trials in children | Yes | see training section |
Documented adherence to ethical considerations | Yes | see training section |
Availability of Standard Operating Procedures (SOP) | Yes | We have quality documents and a quality manual that include 8 finalized policies, 9 policies under review; 24 finalized SOP; 10 SOP under review. |
Capacity to monitor studies (academic trials industry sponsored trials) |
No | The network does not do GxP but we can liaise to preferred partners at European and national level, and some NHs provide those services |
Capacity to monitor performance of collaborating centres | Yes | Performance of sites is monitored for each of the trials executed within the network. Quality improvement activities can be initiated when needed. Information is not publicly available. |
Quality control and quality assurance, raceability and data safety | Yes | Quality manual and quality improvement process, quality improvement plans have been developed and are monitored annually. Not publicly available |