When your approval is due to expire

Expiration and extension of an approval

Amendments must be submitted

Changes in an already approved health research project, that may affect the safety of the subjects, interpretation of the scientific evidence on which the project is based or the implementation or management of the project must also be submitted >>

Submit an amendment

Be aware of the clear consequences for the project if the approval expires before the project is completed. Backward approvals cannot be granted by the Committee.
Initiating a project in violation of the Committee Act (section 41) is punishable >>

If you want to extend the approval

As you approach the expiration of your approval and you want to continue your project.
You need to submit an amendment regarding an extension of your approval. Submit an amendment>>

If you want to reopen the approval

Has your approval already expired. You need to submit for an reopening instead of an extension. Reopening must be submitted as an amendment. Along with the ordinary submission of an amendment you must also send us an account for:

The activities that have taken place since the extension
Why no extension has been submitted in a timely manner
How will you make sure this does not happen again.

You must also pause your trial-related activities until the approval is reopened. Initiating a project in violation of the Committee Act (section 41) is punishable >>

If you want to terminate your projects approval

No later than 90 days after the termination of an approved health research project the committee must be informed of the termination by mail komite@rsyd.dk