4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
AEPC Task Force on Clinical (drug) Trials |
|
| Documented adherence to GCP guideline | No | no studies as of yet conducted |
| Documented adherence to the ethical considerations for clinical trials in children | No | SOP to be developed. Local SOP per center available. |
| Documented adherence to ethical considerations | Yes | some members are involved in local/ national ethic committee work |
| Availability of Standard Operating Procedures (SOP) | No | not yet available |
| Capacity to monitor studies (academic trials industry sponsored trials) |
No | under development |
| Capacity to monitor performance of collaborating centres | No | under development |
| Quality control and quality assurance, raceability and data safety | No | not yet available, to be developed |