4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Medicines for Children Research Network (MCRN) -Hungary |
|
| Documented adherence to GCP guideline | Yes | Studies are conducted in complience with EU Directive 2001/20/EC on Clinical Trials |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | |
| Documented adherence to ethical considerations | Yes | Request of approval by an independent ethics committe with paediatric expertise is done by the Regulatory Authority in Hungary. |
| Availability of Standard Operating Procedures (SOP) | Yes | Hard copies of SOPs on site are available. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | MCRN Hungary does not directly implement the monitoring of clinical trials, however has local contractors available on request |
| Capacity to monitor performance of collaborating centres | No | Monitoring of sites is performed centrally according to Hungarian regulations |
| Quality control and quality assurance, raceability and data safety | No | In progress |