Case statistics on the quality of notifications of clinical trials 2011

The Danish Medicines Agency handles applications for authorisation of clinical trials. Many applications are not valid when the Danish Medicines Agency receives them. The bar chart shows the percentage of the applications, which are valid at the time of notification.

When the applications are received at the Danish Medicines Agency, they are reviewed in order to discover whether any information is missing. An application is regarded as valid if there are no remarks. This is intended to ensure that the applications we receive are valid, so that the case handling is not interrupted due to missing information.

It appears from the Danish Medicines Agency’s Guidelines for application for authorisation of clinical trials of medicinal products on humans what an application for authorisation of a clinical trial must contain. Case handling will not be initiated unless the submitted application is valid.

The bars in the chart show the percentage of the applications for clinical trials, which the Danish Medicines Agency has received, which are valid and not valid at the time of notification.