European Medicines Agency - Regulatory - Regulation of medicines

4 - Quality management



    Description

Name

 

ECAPN - European Child & Adolescent Psychopharmacology Network

Documented adherence to GCP guideline Yes All studies conducted comply with the EU Directive 2001/20/EC on Clinical Trials
Documented adherence to the ethical considerations for clinical trials in children Yes All the network clinical and scientific activities are based upon the Evaluation of risks and benefits, the consent of the parents/ legal guardians and formal (written, when applicable) assent of the child, Operating procedure for privacy, confidentiality data protection, Return of research results to parents and scientific & social communities. Network guidelines are attached and may be available form the website.
Documented adherence to ethical considerations Yes All centres request approval by an independent ethics committee with paediatric expertise before starting all studies, as well as ethics
Availability of Standard Operating Procedures (SOP) Yes See attached document "Guideline" ,also available at the website.,
Capacity to monitor studies
(academic trials industry sponsored trials)
Yes Regular monitoring by CRO for industrial Trials, by the staff of the coordinating centre for the academic studies
Capacity to monitor performance of collaborating centres Yes Monitoring performance of collaborating centres, by CRO
Quality control and quality assurance, raceability and data safety Yes Quality control and quality assurance, traceability and data safety implemented by CRO for industrial Trials, for the academic studies Quality Control, quality assurance, traceability and data safety are managed by by the specific staff members of the coordinating centre