4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
JPeDNet - Japan Pediatric Society Drug Development Network |
|
| Documented adherence to GCP guideline | No | PCTN, Japan conduct GCP compliant clinical trials. JPeDNet itself does not conduct clinical trials. |
| Documented adherence to the ethical considerations for clinical trials in children | No | PCTN, Japan, follows GCP and ethical considerations. JPeDNet itself does not conduct clinical trials. |
| Documented adherence to ethical considerations | No | Central review board of the PCTN, Japan, has paediatric and ethics experts. JPeDNet itself does not perform ethical review for clinical trials. |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | No | JPeDNet does not perform quality control and quality assurance by itself |