Combination studies involving clinical trials of medicinal products and clinical investigations of in vitro-diagnostic medical devices
If a study includes a clinical trial of a medicinal product under the Clinical Trials Regulation (CTR), in parallel with a performance study of an in vitro-diagnostic medical device under the IVDR, two separate applications must be submitted to REK.
The clinical trial of the medicinal product must be submitted under the CTR through the Clinical Trials Information System (CTIS) and will be assessed by NOMA (DMP) and REK KULMU. The application for the performance study must be submitted to REK KULMU or regional REK through the REK-portal. The performance study may also require an application or notification to NOMA; please see NOMA’s website for further information.
The clinical trial and the performance study may be described in one combined informed consent form, or two separate participant informed consent forms may be prepared. In both cases, it must be clearly stated what participation in the two studies entails. Please consult REK’s templates for informed consent forms for further guidance or contact REK KULMU.
Updated 17.09.2026
