4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
RIPPS - Réseau d'Investigation Pédiatrique des Produits de Santé Service de Pharmacologie Clinique (Hôpital Saint Vincent de Paul Groupe hospitalier Cochin – Saint Vincent de Paul) |
|
| Documented adherence to GCP guideline | Yes | Adherence with the EU directive 2001/20 EC in conformity with Law Huriet n° 88-1138 of December 20,1988 modified by the unit of its decrees of application and its subsequent texts, with Good Clinical Practice into force, with article L.4113-6 of the Code of the Public Health and with Law of January 6, 1978 modified.. Frequent monitoring conducted by industry Monitoring report made Ripps complies with the Quality Referential produced by the French Clinical Investigation Centres Network All studies conducted through ripps strictly follows GCP guidelines |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | |
| Documented adherence to ethical considerations | Yes | All trials are approved by an independent ethical comittee and the French Drug Agency. Internal procedures are available for all studies based on national GCP. |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPS comprise SOPs for the planning, preparation, execution and reporting phase of studies. There are also generic SOPs for e.g. auditing etc (soft copy available on request) |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | For industry and academic trials monitoring can be done by RIPPS at least 3 monitoring are done : - Beginning of the trial - End of the trials - After the first inclusion Monitoring of studies is performed by independent GCP trained personnel, according to GCP compliant SOPs. |
| Capacity to monitor performance of collaborating centres | Yes | RIPPS only collaborate with centers which follows good GCP. RIPPS has qualified CRAs available to help and train the investigators of collaborating centers. Moreover, performance is monitored according to SOPs in the RIPPs Quality System |
| Quality control and quality assurance, raceability and data safety | Yes | This is implemented in SOPs of the RIPPS comprehensive Quality System |