4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RITIP - Translational Research Network in Pediatric Infectious Diseases (Red de Investigación Traslacional en Infectología Pediátrica) |
|
| Documented adherence to GCP guideline | Yes | www.ritip.org All our studies are carried out according to the standards of Good Clinical Practice (GCP) guideline. These practices must be documented and renewed every two years. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | All our studies must be approved by Ethics Committes. |
| Documented adherence to ethical considerations | Yes | |
| Availability of Standard Operating Procedures (SOP) | Yes | We follow the RECLIP SOPs |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | Monitoring is delegated to external bodies |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | Yes |