Study file in the recruitment and delivery phase

While the study is ongoing the study files have to be maintained. See SOP Study Files for information and see checklists Sjekkliste gjennomføring av klinisk legemiddelutprøving for sponsor (Norwegian) and Sjekkliste gjennomføring av klinisk legemiddelutprøving for senter (Norwegian).

All unused study drug must either be returned to sponsor or destroyed. The templates below should be used if a specific stock with study drug has been provided for the study.

Studiemedisin – totalregnskap (Norwegian) / Investigational medicinal product – drug reconciliation

Destruksjonslogg (Norwegian) / Destruction of investigational medicinal product