12. november 2018

Who must submit the notification?

It is the investigator and the sponsor who must notify research projects.

The duty to notify is shared by the investigator and the sponsor/sponsors in unison (unless the investigator and sponsor are in fact the same).

The investigator is a person who practises a profession that is recognised for carrying out research and is responsible for the conduct of the trial at a certain trial site. A profession that is recognised for carrying out research could be the position as a researcher or a PhD student or it could be activities specifically related to research work.

The sponsor is the physical or legal person assuming the responsibility for initiation, conduct or financing of a health research project.

If it is a multi-centre trial, it must be notified by the coordinating investigator and the sponsor. A multi-centre trial is a trial carried out in accordance with one trial protocol only, but at different sites in Denmark with a coordinating investigator or with a multitude of investigators.

In case of research initiated or financed by a company, for example clinical trials of medicines, the company or others may handle the practicalities of preparing the notification, but it is the investigator and the sponsor in unison who must submit the notification – at their responsibility.