4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECFS-CTN - European Cystic Fibrosis Society - Clinical Trials Network |
|
| Documented adherence to GCP guideline | Yes | Pharma studies conducted should comply with the EU directive. CTN investigators are GCP trained |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | CTN investigators know these guidelines. They are part of the documents on clinical trial regulations posted on http://www.ecfs.eu/ctn/ |
| Documented adherence to ethical considerations | Yes | Reporting party is currently not setting up studies. Approval request is fulfilled by the study sponsor. At site level, pediatrician is part of IRBs |
| Availability of Standard Operating Procedures (SOP) | Yes | For study conduct: Network performs Pharma initiated studies, following their SOPs For measuring of outcome parameters SOPs of the US network (CFF-TDN) are made available to all sites and EU versions will be available by end of 2011. SOPs are posted on the internal (non-public) website but can be obtained upon request (ecfs-ctn@uzleuven.be) |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | The monitoring is the responsibility of the pharma company or assigned CRO |
| Capacity to monitor performance of collaborating centres | Yes | The CTN coordinating centre follows up on study startup metrics and on recruitment and possible associated problems and delays |
| Quality control and quality assurance, raceability and data safety | Yes | A quality assessment and improvement program is available for the sites. Sites receive a yearly report with their quality metrics. A dedicated quality manager is part of the CTN core team. CTN is not handling study data: = responsibility of the pharma sponsor |