4 - Quality management
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
NorPedMed - Medicines for Children Network Norway (Department of Pediatrics, Haukeland University Hospital) Norway |
|
| Documented adherence to GCP guideline | Yes | The clinical trial units that participate in NorPedMed are staffed with trained research nurses and pediatrician with documented GCP knowledge, and their work comply with the EU Directive 2001/20/EC on Clinical Trials. |
| Documented adherence to the ethical considerations for clinical trials in children | Yes | Ethical requirements on the conduct of studies involving children are incorporated in Norwegian law: "Helseforskningsloven" which is available at this internet-site: https://lovdata.no/dokument/NL/lov/2008-06-20-44 |
| Documented adherence to ethical considerations | Yes | Approval by a competent and independent Ethics Committees is required by Norwegian law for all research involving humans |
| Availability of Standard Operating Procedures (SOP) | No | NorPedMed has not developed a generalised SOP that can be used in all studies at all study sites. |
| Capacity to monitor studies (academic trials industry sponsored trials) |
Yes | The clinical trial units participating in NorPedMed have access competent monitors with the relevant skills to monitor academic trials and industry sponsored trials. |
| Capacity to monitor performance of collaborating centres | Yes | The clinical trial units that participate in NorPedMed have the opportunity to share monitor capacity, and these issues are discussed as perceived necessary at monthly telephone conferences |
| Quality control and quality assurance, raceability and data safety | Yes | These issues are covered by Norwegian law: "Helseforskningsloven" which is available at this internet-site: https://lovdata.no/dokument/NL/lov/2008-06-20-44 |