4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
TEDDY - European Network of Excellence for Paediatric Research |
|
| Documented adherence to GCP guideline | Yes | All members of the TEDDY Network have experience in conducting GCP compliant studies. Moreover, appropriate GCP training is provided to Investigators participating in TEDDY trials prior to the study initiation. Monitoring procedures are in place to ensure GCP compliance of TEDDY studies. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Ethical approval has been obtained for all studies. Provisions highlighted in the 'Ethical considerations' document, including acceptable blood volumes and frequency of sampling in children, have been taken into account in all studies. Specific recommendations tailored to parents, children, industry, GPs, paediatricians and other medical professionals, and European and National Institutions have been prepared by the Network starting from the principles outlined in the Ethical Considerations. |
| Documented adherence to ethical considerations | Yes | Approval by Independent Ethics Committees including paediatric expertise is always requested and obtained for both clinical trials and other studies as per national and local regulations. |
| Availability of Standard Operating Procedures (SOP) | Yes | Internal SOPs are available for clinical trials activities as requested by ICH GCP guidelines and shared among partners by request. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | TEDDY monitoring procedures are in accordance with GCP and other relevant rules and utilize internal and external (CRO and CRA) trained resources. |
| Capacity to monitor performance of collaborating centres | Yes | The Network has the facilities to perform project and trial management activities to monitor performance. It has set up a ‘trial management infrastructure’ including SOPs, data management plan, drug management plan, pharmacovigilance and monitoring plans, in order to deal with the complexity of multinational and multi-centre clinical trials, as well as it has implemented a unique procedure and a unique CTA ‘package of documents’. |
| Quality control and quality assurance, raceability and data safety | Yes | Internal SOPs are available for clinical trials activities as requested by ICH GCP guidelines: – Data Management Plan – Data Security – Data Handling – Audit plan – Audit visit – Handling of no-conformity |