4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
EUNETHYDIS - European Network for Hyperkinetic Disorders |
|
| Documented adherence to GCP guideline | Yes | All trials are designed to comply with EU directive 2001/20/EC on clinical trials. Compliance is monitored and no significant problems have arisen when audits have been conducted. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All projects are passed by local/national ethical bodies and comply with the special ethical requirements for paediatric trials. |
| Documented adherence to ethical considerations | Yes | All projects have received Ethical Committee approval and are regularly monitored for compliance. |
| Availability of Standard Operating Procedures (SOP) | Yes | See 3.5 In the past most sites determined their own SOPs for single site trials or used those determined by industry sponsors. For the FP7 studies the network is collaborating with the University of Dundee/NHS Tayside Clinical trials Unit and will adopt their SOPs where appropriate and available and collaborate with them in the development/adoption of new SOPs where required. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | All trials adhere to the monitoring of trials as determined by ICH GCP |
| Capacity to monitor performance of collaborating centres | Yes | There is a lead site for each trial/study who take responsibility for implementing monitoring of performance either through a clinical trials unit or via an external CRO. |
| Quality control and quality assurance, raceability and data safety | Yes | as in 4.6 |