4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
FINPEDMED - Finnish Investigators Network for Pediatric Medicines |
|
| Documented adherence to GCP guideline | Yes | All studies are conducted and monitored in compliance of all local and national laws and regulations, including EU clinical trials directive, EU CTR and GCP, as well as current EU Commission Ethics guideline. More information: https://finpedmed.fi/en/resources/regulations- and-guidelines/ |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | In Finland, National Ethics Committees has pediatric expertise available for a trial evaluation process. The national committee works under national and EU laws, and according to this EU Ethics guideline. |
| Documented adherence to ethical considerations | Yes | see above. |
| Availability of Standard Operating Procedures (SOP) | No | |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | For academic trials ICH GCP valid monitoring services are offered (in collaboration) by the University Hospitals Research Organizations. |
| Capacity to monitor performance of collaborating centres | No | |
| Quality control and quality assurance, raceability and data safety | Yes | FINPEDMED operations are fully and methodically controlled - by QC, QA and Data Safety: All the operations and trial conduction are put into practise in the University Hospitals and Central Hospitals, where the QC, QA and Data Safety are executed in every sector of hospital patient care by internal Standard Operating Procedures (i.e. hospital directions). |