Control

Read here about control in the regional committees and find the control manual for use in the regional committees' monitoring of approved research projects.

The regional committees supervise that research projects are carried out in accordance with the granted permission. However, this does not apply to clinical trials with medicinal products, where the Danish Medicines Agency is the supervisory authority.

The regional committees also typically have the control task in cases where a project is approved by the NVK (National Scientific Ethical Committee).

Control can be carried out through inspections at the trial site, and the committee can, as part of the control, demand to receive all relevant information about the research project, including information about the health conditions of the trial subjects, etc. The committee can also require a project to be changed or, in special cases, stop the project.

A control manual has been developed for use by the regional scientific ethics committees in monitoring approved research projects. The committee can also follow a project's progress and demand that the final research report or publication be sent to the committee. The committee can demand a reasoned statement from the trial responsible or sponsor in cases where the project is not completed. This applies to both non-medicinal and medicinal trials.

Control Manual

For use by the regional scientific ethics committees in monitoring approved research projects.

Download the manual (PDF)

Last updated 01-02-2024

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