- Presentation of the project’s overall organization, cf. CTR Appendix 1, M (64). If section 1 of the European Commission’s template for Site Suitability is completed, this requirement will be met. Alternatively, an enrolment plan can be attached if the number of planned study participants per study site is not stated elsewhere in the application.
- CV for principal investigators (PIs) at each trial site in Norway. It is recommended to use the European Commission’s Investigator Curriculum Vitae template. The CV must clearly state what clinical competence the PI has, including: prior experience with clinical trials, experience with patient care and a description of any training in good clinical practice (ICH-GCP).
- Conflict of interest statements for PIs at each trial site in Norway. It is recommended to use the European Commission’s Declaration of Interest Template.
