Harmonised Nordic Ethical Evaluation of Clinical Trials

The project aims to foster Nordic collaboration and competitiveness in clinical trials by developing harmonised Nordic procedures for the ethical assessment of clinical trials. The deliverables expected from the project include

  • mapping of current national best ethics committee practices and available document templates in the Nordic countries;
  • a Nordic seminar aiming at establishing recommendations for common operating procedures and guidance documents for Nordic ethics committees;
  • recommendations for common templates to be published by the ethics committees for the purpose of guiding investigators and sponsors in the application process (including an analysis of possibilities to use identical/similar electronic handling tools in the Nordic countries, in addition to the common framework provided by the electronic portal of the European Medicines Agency);
  • recommendations for the establishment of a joint Nordic body to coordinate and harmonise the ethical review of clinical trials in the Nordic countries; and
  • a project report that will serve all involved parties as a source of information on the ethical review process of clinical trials in the Nordic countries.
Facts about the project
Project manager

Hospital District of Southwest Finland
Project Leader: Mika Scheinin