4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PRINTO - Pediatric Rheumatology International Trials Organisation |
|
| Documented adherence to GCP guideline | Yes | This is valid for studies with pharma industry while for academic studies funding are not sufficient for a proper local monitoring |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | all studies are approved by the local ethics committees according to the law of the participating country |
| Documented adherence to ethical considerations | Yes | Not all ethics committees have a declared pediatric expertise |
| Availability of Standard Operating Procedures (SOP) | Yes | PRINTO obtained certification by ISO 9001 in February 2009, renewed in September 2012 for the period 2012-2015. SOP are available in-house and they mainly relate to the assessment of response to therapy in JIA on behalf of pharmaceutical industries |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | For academic studies monitoring is done through standardises questionnaires (no local monitoring available for funding issues). For pharma sponsored studies GCP monitoring is done by the companies |
| Capacity to monitor performance of collaborating centres | Yes | Performance is evaluated by the rate of recruitment in collaborative studies |
| Quality control and quality assurance, raceability and data safety | Yes | Quality control for primary outcome assessment for pharma companies is done via fax/e-mail by receiving related data. For academic studies monitoring for efficacy and safety is done entirely by PRINTO centrally with electronic methods (no local monitoring) |