Research ethics review of pharmaceutical clinical trials (CTR)
The EU regulation Clinical Trials Regulation 536/2014, CTR entered into force on January 31, 2022. On behalf of the ethics authorities in Norway, REK KULMU carries out the research ethics assessment of applications that fall under CTR. The assessments are made in accordance with general research ethics principles. CTR is the overriding legislation, but the ethical principles described in the Health Research Act will apply matters that are not mentioned in CTR.
We refer to NoMA’s website for more information on clinical trials under CTR.
We recommend using the templates that are published at the European Commission’s website. See further description of the above-mentioned documents under point 3, Part II application (national application).
Note that the version number and date specified in CTIS must be in accordance with the version number and date specified in the respective documents.
