4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ScotCRN - Scottish Children's Research Network |
|
| Documented adherence to GCP guideline | Yes | |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Only trials with ethical approval from the national ethics board are supported. Paediatric representation on the ethics committee |
| Documented adherence to ethical considerations | Yes | |
| Availability of Standard Operating Procedures (SOP) | Yes | All listed on our website. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | All studies are monitored by local R and D office, commercial auditors and study specific monitors |
| Capacity to monitor performance of collaborating centres | No | all monitored externally |
| Quality control and quality assurance, raceability and data safety | Yes |