European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management



    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