4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
Pedmed-NL - Medicines for Children Research Network Netherlands |
|
| Documented adherence to GCP guideline | Yes | All study procedures are conform GCP, as obligated by Dutch law in drug research in children |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Yes, implemented in SOP. SOP is for internal use only. |
| Documented adherence to ethical considerations | Yes | Yes, implemented in SOP. SOP is for internal use only. |
| Availability of Standard Operating Procedures (SOP) | Yes | SOPs are not publicly available, but may be made available upon request. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | No personel to provide this service at the moment. However, we do provide matchmaking between study team reliable partners for high quality monitoring. |
| Capacity to monitor performance of collaborating centres | Yes | yes, through regular meetings with participating sites |
| Quality control and quality assurance, raceability and data safety | Yes | Yes, implemented in SOPs |