​Norwegian

​The content on this page can be used as guidance for projects that plan to extract and use health data from UNN, and for those that intend to test medical equipment in clinical use in conjunction with quality evaluation, research, and innovation.

Scope and Purpose​​ | Definitions and concepts​ | Checklist (in Norwegian)​

Plan project

• Plan the project​
  
• Clarify purpose with project​
  
• Clarify which data sources will be used​
  
• Clarifications in projects concerning the development and testing of medical equipment​
  
• Ethical assessments​
  
• Project description​
  
• Application for approvals​
  
• Consent and information obligation​
  
• Risk assessment​
  
• Data protection impact assessment (DPIA)​
  
• How to involve the Data Protection Officer at UNN​
  
• Clarifying innovation potential​
  
• Cooperation agreements and rights​
  
• Data management plan​
  
• Clinical trials​
  

Carry out and Complete project

• ​​Ordering, delivery and storag​e of data​​
• Analysis of data​
• User participation​
• Protection of participants' rights​
• Deviations and undesirable events​
• Change notification to PVO and REK​
• Publication and dissemination​
• Completion of the project and final report​​​

About the guide

The guide has been created in collaboration between UNN HF, Visual Intelligence at UiT, Helse Nord IKT, and the Norwegian Centre for e-Health Research. 

The website is operated in cooperation between the Centre for Clinical Artificial Intelligence (SPKI) and the Clinical Research Department at UNN. 

If you want to give us feedback on the content in this guide or if you have found errors, etc., please contact us. ​