4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
OKIDS - Medicines for Children Research Organization Austria |
|
| Documented adherence to GCP guideline | Yes | OKIDS provides GCP training for clinical trial teams and hence is compeltly aware and compliant with GCP requirements |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | OKIDS trials as any other pediatric trial in Austria needs to seek ethical approval for planned studies in vulnerbale minors. Trials with drug developement aspects accordingly need to follow the legal process alraedy in place in Austria and need to be submitted as well to the competant authorities of Austria |
| Documented adherence to ethical considerations | Yes | OKIDS declares that approval by an independent ethics committee with paediatric expertise for all studies is conducted and a standard process in Austria |
| Availability of Standard Operating Procedures (SOP) | Yes | www.okids-net.at ( intranet - closed area for OKIDS personell) |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | The OKIDS network may provide monitoring activities on demand for academic trials ( trained monitores available at sites) |
| Capacity to monitor performance of collaborating centres | Yes | OKIDS has alraedy started the process to monitor collaborative site activities |
| Quality control and quality assurance, raceability and data safety | Yes | SOPs assure the internal quality control processes during clinical trial mangement ; respective clinical trial data bases are under academic sponsors governance at the respective sites and are not under the direct responsibility of the OKIDS network; |