Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website

Updated version of the Danish Medicines Agency's guidance on risk-adapted recording and reporting of adverse events in clinical trials is now available on the website

The Danish Medicines Agency’s guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 has been updated and version 2.0 is now available on the website, in both Danish and English. The guidance has been updated with further clarification on the requirements, if risk-adapted adverse event management is implemented. For an overview of the changes, please refer to the change log in the guidance document.

The guidance on risk-based recording and reporting of adverse events in clinical trials on medicinal products under Regulation (EU) no. 536/2014 can be found on the Danish Medicines Agency's website about safety reporting in clinical trials of medicinal products.

We expect to update the guideline regularly. Therefore, we encourage all stakeholders to, generally, send comments, input, and questions regarding the guideline.