4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
FP-MCRN - Family Pediatricians Medicines for Children Research Network |
|
| Documented adherence to GCP guideline | Yes | FP-MCRN studies are conducted according to GCP guideline,to the indications of the European Regulation on Clinical Trials(n, 536/2014),to the Italian Guideline for the management of clinical investigations in pediatrics (Agency for the Regional Sanitary Services) and to the Ethical Considerations for clinical trials on medicinal products conducted with the paediatric population |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | FP-MCRN studies are conducted according to GCP guideline,to the indications of the European Regulation on Clinical Trials(n, 536/2014),to the Italian Guideline for the management of clinical investigations in pediatrics (Agency for the Regional Sanitary Services) and to the Ethical Considerations for clinical trials on medicinal products conducted with the paediatric population |
| Documented adherence to ethical considerations | Yes | All the FP-MCRN studies request approval by indipendent Ethics Committee in which are involved pediatric experts |
| Availability of Standard Operating Procedures (SOP) | Yes | FP-MCRN has improved its own standards of operational procedures (SOP), granting the highest levels of control in transparency, safety and quality of data and of submitted studies. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | The FP-MCRN has got a Quality Control System ( FPI- Monitor) according to Good Clinical Practice Guideline |
| Capacity to monitor performance of collaborating centres | Yes | We have the capacity to monitor performance of colaborating centres ( e.g. we take part in the Research Monitoring Committee of the study: "Effectiveness of beclomethasone versus placebo for prophylaxis of viral wheezing in preschool" of Mario Negri Institute,Milano). |
| Quality control and quality assurance, raceability and data safety | Yes | The FP-MCRN has got a Quality Control System ( FPI- Monitor) that guarantees the GCP, a Quality Assurance ( FPI- Auditor ) which carries out some audits to check the QA as required by the GCP regulations, a Safety Monitoring ( control of possible ADRs in clinical trials ). The traceability, the transparency and the safety of data are submitted to an computer engineering company |