For trials that must be submitted to RVK, NVK or VMK under the directive, it is the investigator or principal investigator and sponsor who must notify the research project. Read more below.
Health science projects
The obligation to notify a health science research project lies jointly with the investigator and the sponsor(s), and both must sign the notification, unless the investigator and sponsor are the same.
Health data science projects
The obligation to notify a health data science research project rests jointly with the principal investigator and the sponsor, and both must sign the notification, unless the principal investigator and the sponsor are the same.
Multicenter trials
In the case of a multi-center trial, this must be notified by the coordinating investigator and the sponsor.
Trials funded or initiated by a company
Research that a company has initiated or financed, e.g. For research initiated or financed by a company, e.g. clinical trials with medicines, the company or others can take care of the practicalities of preparing the notification, but it is the coordinating investigator or principal investigator and sponsor jointly who must submit the notification - under the responsibility of both.
For applications under CTR, MDR or IVDR
For applications under MDR and IVDR, it is the principal investigator together with the sponsor who must notify the trial.
Under CTR, it is the sponsor who notifies the trial.
If the sponsor and the principal investigator are the same, they are the sponsor-investigator and can submit to both MDR, IVDR and CTR.
The principal investigator will often be the same as the investigator, but if there are multiple sites, the principal investigator will be the Principal Investigator (PI)