CT-Notifications and reports

Authorities and other registries require notifications and reporting, see CT SOP Ongoing Trial Reports and Notifications.

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 CT SOP Modifications after Trial Start.

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 CT SOP Safety Reporting. A DSUR template may be used for annual safety reporting. For more information about safety, see Bivirknings-/sikkerhetsrapportering i klinisk utprøving av legemidler.

Other external registries should be maintained, see CT SOP Application Process, Approvals and Start-up.