Pharmaceutical companies, including CROs (Contract Research Organisations) can apply for authorisation to conduct a clinical trial in humans via DKMAnet, the Danish Health and Medicines Authority's access-controlled extranet.
Clinical trials and DKMAnet
There are four different clinical trial services available to pharmaceutical companies on DKMAnet:
- Application for new clinical trial authorisation (CTA)
- Application to amend an authorised clinical trial
- Safety surveillance of authorised clinical trial
Annual safety report (ASR, DSUR)
Change of trial status (ended trial, temporarily halted trial, or premature trial closure)
Other safety-related information
- Notification about authorised clinical trial
Final clinical study report and publication
Extension of trial period relative to the date approved on the Danish authorisation.
New trial sites/change of trial sites (including updated XML file).
Change of principal/coordinating investigator (including updated XML file).
Change of CRO/applicant
To the extent possible, the forms collect data from the EudraCT application form (which is to be uploaded as an XML file). The documentation must be attached in PDF format.
Questions and answers on clinical trials and DKMAnet
Read about Clinical trials and DKMAnet: Clinical trials and DKMAnet - questions and answers.
In the box to the right, you can find guidance notes on how to submit information to the Danish Health and Medicines Authority concerning clinical trials of medicines via DKMAnet.
Access to DKMAnet
To gain access to DKMAnet, the company must appoint a security administrator (please see the form in the box to the right). Before appointment, the security administrator must have an employee signature from Nets DanID installed on his/her computer. The employee signature must be registered in the name of the company.
A Digital Signature is ordered from the Nets DanID website.
Security administrators and users working for companies that do not have a Danish company registration number must be issued a CUG certificate from the Danish Health and Medicines Authority (please see the form in the box to the right).
Questions and answers about access to DKMAnet.
Read about access to DKMAnet: Access to DKMAnet - questions and answers.
