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 ICH 6 GCP guideline,to the indications of the European Directive on Clinical Trials(2001/20/EC),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 – EMA 2008 and according to ehe GVP – Guidelines on good pharmacovigilance pratice -Module VIII- PASS |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | FP-MCRN studies are conducted according to ICH 6 GCP guideline,to the indications of the European (2001/20/EC) Directive on Clinical Trials,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 – EMA 2008 and according to ehe GVP – Guidelines on good pharmacovigilance pratice -Module VIII- PASS . |
| Documented adherence to ethical considerations | Yes | All the FP-MCRN studies request approval by indipendent Ethics Committee |
| 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 ICH6 Good Clinical Practice Guideline Indicate if the reporting party implements the monitoring of paediatric trials according to ICH 6 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 ICH-GCP, a Quality Assurance ( FPI- Auditor ) which carries out some audits to check the QA as required by the ICH 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 |