Combined studies with a clinical trial and a simultaneous performance study

Danish Medicines Agency, in collaboration with Danish Medical Research Ethics Committees, has developed a new guideline allowing sponsors of combined studies with a clinical trial involving simultaneous performance study of a in vitro diagnostic devices, to apply for approval through a national coordinated process. This coordinated process ensures that sponsors receive simultaneous decisions on both the clinical trial and the performance study. It is voluntary for sponsors to apply through a coordinated process.

Link to the guideline in PDF-format. 

The Danish Medicines Agency is also responsible for coordinating EU collaboration under the project 'COMBINE': Combined studies - European Commission (europa.eu).