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 regulation. CTN investigators are GCP trained - this is documented at entry to network. Individual trial sponsors monitor GCP adherence, per trial. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | CTN investigators are familiar with these guidelines and they are often covered in our annual training courses. 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. |
| Availability of Standard Operating Procedures (SOP) | Yes | For study conduct: network performs pharma initiated studies, following their SOPs For measuring of outcome parameters, numerous ECFS-CTN SOPs are available on the ECFS eLearning platform and can be provided 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 | ECFS-CTN monitors study set and recruitment at member sites using a proprietary software. |
| Quality control and quality assurance, raceability and data safety | Yes | A quality assessment and improvement program is available for the sites. Sites receive personalised annual quality reports. This allows sites to benchmark themselves against other sites, and identify areas for improvement. A dedicated quality manager is part of the CTN core team. CTN is not handling study data: = responsibility of the pharma sponsor |