4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
HunPedNet - Hungarian Primary Care Pediatricians’ Clinical Research Network |
|
| Documented adherence to GCP guideline | Yes | Studies are conducted according to GCP and comply with the EU Directive 2001/20/EC on Clinical Trials. It will be indicated on the webpage. GCP training for investigators is mandatory in every five years in Hungary. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | We keep ethical considerations for clinical trials on medicinal products conducted with the paediatric population. It will be indicated on the webpage. https://ett.aeek.hu/bioetikai-kodex/ |
| Documented adherence to ethical considerations | Yes | It will be indicated on the webpage. Independent ethics committee approves and supervises clinical trials in Hungary. |
| Availability of Standard Operating Procedures (SOP) | No | undergoing process is the development of different SOPs for the sites |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | CROs monitor the clinical trials. Academic reseach could be monitored by HunPedNet members based on request. |
| Capacity to monitor performance of collaborating centres | Yes | its development is undergoing process |
| Quality control and quality assurance, raceability and data safety | No | Its development is undergoing process. Currently CROs monitor the trials in Hungary. |