2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
PRINTO - Pediatric Rheumatology International Trials Organisation |
|
| Existence of an identified contact person for external enquiries | Yes | PRINTO international coordinating centre in Genoa (Italy) with PRINTO Senior Scientist plus 12 research assistants working full-time |
| Existence of an internal steering committee | Yes | |
| Existence of an external advisory steering committee directing the reporting party | Yes | Committee are formed ad-hoc based on the specific study needs |
| Existence of a website | Yes | www.printo.it or www.pediatric-rheumatology.printo.it |
| Existence of newsletter | Yes | Usually one per year general newsletter plus several per year specific to each study |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | Ad-hoc web-based databases are created for the purposes of data collection of the specific trial |
| Provisions to ascertain data protection and data security | Yes | For the online data collection databases are put on an https platform with access restricted with username and password only to registered centres (e.g. centres with ethics committee approval) |
| Procedures to access the database by third parties | Yes | A request has to be done to the PRINTO Chairman and the request is then discussed for approval by the PRINTO Advisory Council |
| Access to external databases/registries | No | |
| Standardised process to access an external database | No |