For pharmaceutical clinical trials conducted in Norway, part I is assessed by NoMA and REK KULMU.
All Part I documents must be in English, with the exception of the protocol synopsis, which must be written in Norwegian.
The length of the protocol synopsis should be held to a maximum of two pages and include a separate section on ethical considerations relating to the clinical trial and should be written in an understandable way to a layperson. See point 5.8 of the QnA document on the European Commission’s website for further guidance.
Questionnaires to be used in Norway must be included in the Part I application dossier. These must be submitted in English.
