Reporting and notifications

SOP Rapporteringer og meldinger etter studiestart (Reports and notifications after the start-up of trials)

SOP Protokolltillegg og endringer etter studiestart (Protocol supplements and amendments after the start-up of trials)

Ongoing safety reporting:

SOP Rapportering av uønskede medisinske hendelser og bivirkninger (Reporting of adverse medical events and side effects)

SOP Årsrapportering (Annual reporting) with template for DSUR

Maintenance of external registration

SOP Søknadsprosess, godkjenninger og oppstart (Application process, approvals and start-up)