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 | The Network has set up a ‘trial management infrastructure’ including SOPs, data management and drug management plans, pharmacovigilance and monitoring plans, in order to deal with the complexity of multinational and multi-centre clinical trials. It has also implemented a unique procedure and a unique CTA ‘package of documents’, all in compliance with GCP and CTs Directive. The procedures will be updated to take into account what required by the new CTs Regulation and related guidelines. All studies conducted under TEDDY Network umbrella have received approval by ECs and CAs. |
| 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. In addition TEDDY has published the results of the TEDDY Survey on the ethical requirements for the paediatric population. Finally specific recommendations tailored to parents, children, industry, GPs, pediatricians 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 clinical trials and other studies as per national and local regulations. |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPs are available for clinical trials activities as requested by ICH GCP guidelines and shared among partners by request. A list of SOPs to be implemented in a clinical trial is available at the TEDDY website (http://www.teddynetwork.net/sops-for-paediatric-clinical-trials/). |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | All studies conducted under the TEDDY umbrella are submitted to monitoring procedures in accordance with GCP and other relevant rules related to each specific study, as specified in the Study’s Monitoring Plan. A Site Initiation Visit is performed before the first patient is enrolled in order to ensure that everything in ready at each clinical site. Regular monitoring visits are performed to verify that the patients safety and well-being are protected, the reported trial data are accurate, complete, and verifiable from source documents and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s). Once all patients have concluded the study and the database is locked and ready for statistical analysis, a close-out visit occurs. |
| Capacity to monitor performance of collaborating centres | Yes | The Network has the facilities to perform project and trial management activities to monitor performance. Metrics and indicators are adopted case by case. |
| Quality control and quality assurance, raceability and data safety | Yes | Internal SOPs are available for clinical trial activities as requested by ICH GCP guidelines: – Data Management Plan – Data Security – Data Handling – Audit Plan – Audit Visit – Handling of no-conformity. |