Amendments to clinical trials

The Danish Medicines Agency receives many enquiries about amendments to clinical trials. We have therefore drawn up a form containing a list of significant changes for which it is necessary to apply for an authorisation. The form also indicates which changes that are only to be sent to the regional ethics committee.

You can find the form about amendments to clinical trials via the factbox to the right.

For further information, please contact Lene Grejs Petersen, tel. +45 4488 9305 or e-mail lgp@dkma.dk.

Danish Medicines Agency, 20 November 2008