- There is no fee to the Norwegian ethics authorities regarding an application for prior approval of clinical trials, however, please see DMP’s website for any possible fees to DMP.
- In line with the EMA guidelines , ICH-GCP R3 will be applicable from July 23, 2025. It is expected that investigators participating in patient-related activities will attend an updated GCP course (R3) before this date. REK KULMU should not receive updated GCP documentation. For new CTR applications, it must be documented that the principal investigator(s) has updated GCP competence (R3) or it must be confirmed that they will attend a GCP course (R3) before participants are recruited to the trial.
- REK KULMU should not receive or evaluate progress reports or adverse event reports (DSUR, ASR) for ongoing studies. Only in case of serious adverse events that may affect the benefit/risk assessment resulting in changes to approved documents such as the protocol and/or the Informed Consent Form(s), should a substantial modification application be submitted.
- A final report should not be submitted to REK KULMU. For medical device studies submitted via the REK-portal, a final notification must be submitted in order to close the case in the portal.
- Annual updates of insurance certificates should not be submitted.
- The Informed Consent Form(s) and possible recruitment material must be presented in a language in which the potential participant language is proficient. However, REK KULMU should not receive or assess possible translations of Informed Consent Form(s) to foreign languages. It is recommended to use a certified translator; however, it is the responsibility of the sponsor to ensure that the translation is of good quality and corresponds to the approved text in the Norwegian ICF.
- Patient cards, thank-you cards, interview guides for study personnel, or other study information that does not involve the identification or recruitment of participants should not be submitted as part of the application, as these documents are not reviewed by REK KULMU.
- The document(s) that informs participants about the institution’s and sponsor’s legal basis for data processing are regulated by the General Data Protection Regulation (GDPR). Therefore, these documents should not be submitted as part of the application for studies regulated under CTR, MDR, or IVDR.
