4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
SPACE - Severe Paediatric Asthma Collaborative in Europe |
|
| Documented adherence to GCP guideline | Yes | SPACE database complies with the GCP guideline, the Data Protection Act 1998, the Data Protection Directive 95/46/EC of the European Parliament and of the Council (1995), and the Regulation (EU) 2016/679 (General Data Protection Regulation). These are specified in the project protocol. |
| Documented adherence to the ethical considerations for clinical trials in children | No | Not applicable yet |
| Documented adherence to ethical considerations | Yes | The project has been approved by the ethics committees in all participating countries. |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | Not applicable yet |
| Capacity to monitor performance of collaborating centres | No | Not applicable yet |
| Quality control and quality assurance, raceability and data safety | Yes | The database will be held and administered at HIC at the University of Dundee. The database administrators have considerable experience of managing large databases for respiratory diseases. Database management and chief investigator will regularly review cases with feedback to site investigators to clarify data inconsistencies and to address missing or incomplete data. Audit of the informed consent process and source data verification will be conducted on a sampling basis. Not publicly available yet |