2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECFS-CTN - European Cystic Fibrosis Society - Clinical Trials Network |
|
| Existence of an identified contact person for external enquiries | Yes | |
| Existence of an internal steering committee | Yes | http://www.ecfs.eu/ctn/ctn-organisation-chart |
| Existence of an external advisory steering committee directing the reporting party | Yes | ECFS Board: http://www.ecfs.eu/ctn/ctn-organisation-chart |
| Existence of a website | Yes | |
| Existence of newsletter | Yes | Public Newsletter by the ECFS and internal newsletter by ECFS-CTN |
| Existence of internal databases for disease, condition treatment and/or outcome | Yes | All CTN sites have internal patient database + close cooperation with the ECFS European Patient Registry https://www.ecfs.eu/projects/ecfs-patient-registry/intro |
| Provisions to ascertain data protection and data security | Yes | Not fully applicable: Network is not collecting study data (done by sponsor) Sites follow internal procedures for data protection. EU registry procedures: see http://www.ecfs.eu/projects/ecfs-patient-registry/intro |
| Procedures to access the database by third parties | Yes | Indirect access to data provided upon request and after approval |
| Access to external databases/registries | Yes | National registries |
| Standardised process to access an external database | Yes |