Guidance for clinical research

Medical and health research involving humans, human biological material or health data is governed by comprehensive national legislation, guidelines and regulations, as well as international laws and guidelines.

Use of national procedures (Standard Operating Procedures, SOPs) for individual investigators or trial personnel:

  • As an investigator or trial employee in a clinical trial of a medicinal product, you are responsible for following procedures that apply in your regional health authority, health trust or institution.
  • Check that your institution has implemented the procedures for clinical trials of medicinal products (LM), studies of other interventions (AI) and/or medical devices (MU) in its governing documents.
  • If you have any suggestions for changes or additions to SOPs or attachments, please use the “Feedback” button at the bottom of the page.

Read about the implementation of SOPs at individual regional health authorities, health trusts or institutions

The SOP collection has been developed by a working group at NorCRIN with participants from all of Norway’s university hospitals, as well as representatives of the hospital pharmacies.

It is our wish that those of you who use the revised national procedures/guidelines for clinical research let us know if you find any errors or omissions. Please send your feedback to