2 - Network organisation and process
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
NorPedMed - Medicines for Children Network Norway (Department of Pediatrics, Haukeland University Hospital) Norway |
|
| Existence of an identified contact person for external enquiries | Yes | Please see our internet site, listing contact persons at all participating clinical trial units and the contact persons at the secretariat (https://www.legemidlertilbarn.no/forskning/Sider/NorPedMed-Coodinating-office.aspx). |
| Existence of an internal steering committee | Yes | The responsible pediatrician at each participating pediatric clinical trial unit constitute the internal steering committee and meets monthly at a telephone conference. |
| Existence of an external advisory steering committee directing the reporting party | Yes | The steering committee at Medicines for Children Network, Norway is responsible for financial and structural issues of NorPedMed. |
| Existence of a website | Yes | https://www.legemidlertilbarn.no/forskning/Sider/Medicines-for-Children-Research-Network-Norway.aspx |
| Existence of newsletter | Yes | Medicines for Children Network, Norway publishes a monthly newsletter. Issues relating to NorPedMed is published on that newsletter, whenever relevant news need publishing |
| Existence of internal databases for disease, condition treatment and/or outcome | No | The responsible pediatrician at the pediatric clinical trial units participating in NorPedMed are also senior pediatricians at their respective pediatric departments. Thus, their personal knowledge and network collectively constitute a structure that resembles an "informal database or disease registry" that can be used to plan future studies. Thus, NorPedMed has no need for additional databases or registries particularly dedicated for this purpose. |
| Provisions to ascertain data protection and data security | Yes | NorPedMed answers to Norwegian law as regards patient confidentiality and data protection |
| Procedures to access the database by third parties | No | |
| Access to external databases/registries | No | There are excellent nominative registries in Norway as regards drug prescriptions and diagnoses. However, NorPedMed will have to approach these registries using the same systems, and also act within the same legal structures, as all other bodies or institutions. |
| Standardised process to access an external database | Yes | NorPedMed will have to follow the same rules for access as everybody else, and these rules are standardised and freely available on the internet. |