All applications for approval of drug trials to be conducted in EU/EEA countries must be applied for via the EU application portal CTIS.
However, if the clinical trial is to be carried out outside CTR’s geographical scope, approval must be sought from REK via the REK portal; contact the regional REK in the geographical region you belong to if you have questions regarding such studies.
REK KULMU does not offer user support for CTIS; please contact the European Medicines Agency (EMA) for technical support in CTIS.
For trials that are approved under CTR, CTIS must be used to submit modification applications and adverse events.
A CTR application consists of two parts. Part I consists of the documentation which, in a multinational study, is common to all participating Member States (protocol, questionnaires etc.). Part II contains documentation that is adapted to each individual Member State (Subject information and informed consent in Norwegian, insurance certificate etc.).
We recommend that applicants familiarise themselves with the document Quick guide for sponsors – Regulation 536/2014 in practice, which is available on the European Commission’s website. Reference/resource pages:
- Clinical Trials Regulation 536/2014. Appendix 1 describes what to include in a CTR application
- The European Commission’s website for authorized documents, including CTEG’s Questions and Answers document and the guidance document for the transition of clinical trials.
- Dokumentet Part II Document Harmonisation Guidance
- DMPs webpage
