European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management



    Description

Name

 

EAPRASnet - European Academy of Paediatrics Research in Ambulatory Settings Network

Documented adherence to GCP guideline No We do not conduct clinical trials
Documented adherence to the ethical considerations for clinical trials in children No We do not conduct clinical trials
Documented adherence to ethical considerations Yes
Availability of Standard Operating Procedures (SOP) Yes Non available at present
Capacity to monitor studies
(academic trials industry sponsored trials)
No
Capacity to monitor performance of collaborating centres No
Quality control and quality assurance, raceability and data safety No