Notifications and reports

Authorities and other registries require notifications and reporting, see SOP Rapporteringer og meldinger etter studiestart (Norwegian).

Changes to the protocol should be documented and, if considered substantial by any relevant authority, the protocol changes should be approved by that authority before implementation, see SOP Protokolltillegg og endringer etter studiestart (Norwegian).

Serious adverse events that are unexpected and possibly related the investigational medicinal product should be reported to authorities. Also an annual safety reporting is required, see Safety Reporting. A DSUR template may be used for annual safety reporting. For more information about safety, see Side effect/safety reporting in clinical trials of medicinal products.

Other external registries should be maintained, see SOP Søknadsprosess, godkjenninger og oppstart (Norwegian).