4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ECAPN - European Child & Adolescent Psychopharmacology Network |
|
| Documented adherence to GCP guideline | Yes | No changes. Continuous training and study specific |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | no changes |
| Documented adherence to ethical considerations | Yes | no changes |
| Availability of Standard Operating Procedures (SOP) | Yes | Study specific |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | Members of the network have developed investigator-initiated studies (see the IMI-2 project AISM-2 trials) and counted on academic CROs to carry them on. |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | Yes | Yes, quality processes accessible through the website |