New Protocol Template for Clinical Trials

We have updated our protocol template to include even more guidance from both the Danish Research Ethics Committees and the Danish Medicines Agency.

By starting out from this improved protocol template it can to a higher degree be assured that the regulatory demands to the protocol are met – and hopefully the process of developing the protocol is made easier and better.

We have taken the initiative to this update based on the frequent considerations, that we are raising in the approval process and hopes that the template can aid in reducing the number of considerations.

In addition to that, we have gathered the input from dialogue meetings with the researchers regarding the benefit of dedicated guidance on our homepage for the non-commercial research.  

Until this dedicated guidance is in place, you can find the general information on our homepage, where also our contact point is available.  

The protocol template can be found on our homepage under How to Apply for Clinical Trials with Medicinal Products in Denmark and Europe in its own blue box as well as under  Clinical trials - questions and answers under “Requirements for documents”.

It is a complex task to perform a clinical trial, but we hope that the new template in combination with the GCP-units CTIS guidance (also found on our homepage) can help out with providing structure and make the application process more manageable.