Early-phase units

Based on a mandate from the Norwegian Ministry of Health and Care Services, Southern and Eastern Norway Regional Health Authority and NorCRIN have mapped available resources for early-phase trials in Norway, limited to phase I and II trials, but not limited to research on medicinal products. Read about the results of this work (PDF).

The group has also described the requirements that should be set for early-phase units. The requirements have been harmonised with internationally available rules, including a work begun by the European Medicines Agency (“Guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation”) as part of “Improving safety of first-in-human clinical trials”. This has been adapted in general to Nordic and in particular to Norwegian conditions. Read about the results of this work (PDF).

NorCRIN has developed a procedure for early-phase trials, “SOP LM 1.04 First in Human (FIH) and Early Phase Clinical Trials”. It can be found in the list of documents under the “LM 1 General SOPs” tab on this page.

NorCRIN has asked the Norwegian Medicines Agency (SLV) to establish an approval process for early-phase units in Norway. Read more about the process (PDF).