DKMAnet: Clinical trials - questions and answers

Updated 28 November 2019

General

Why do I have to use DKMAnet?

DKMAnet is a shared portal for applications for clinical trials on medicinal products to both the Danish Medicines Agency and the Scientific Ethical Committee System. Applications for clinical trials are submitted via this portal to both authorities. The portal is divided into four services containing forms in which the applicant provides relevant information and attaches documentation in PDF format. 

Applicants can apply for a new clinical trial authorisation and for authorisation to amend an ongoing clinical trial, and safety surveillance notifications such as annual safety reports, end of trial notifications as well as general notifications can be submitted to both authorities.

It provides better data safety as you are submitting documents via an encrypted connection.

If you represent a company, CRO or the like, you can read more about access to the DKMAnet here: Link 

If you are a doctor/dentist applying for a clinical trial authorisation, you use your NemID to sign for and submit the application via this link.


Do I also have to apply for a clinical trial authorisation from the Scientific Ethical Committee System when I use DKMAnet?

No, your application is automatically sent to the committee system as well. The checklist lists the documents sent to the Danish Medicines Agency and the documents sent to the committee system.


How do I know which documents are sent to the Danish Medicines Agency and the Scientific Ethical Committee System, respectively?

The checklist lists the documents sent to the Danish Medicines Agency and the documents sent to the committee system.


Can I set limiting rules for my PDF files (e.g. ’Document Assembly: Not Allowed’, ’Page Extraction: Not Allowed’, electronic signature, etc.) and/or encrypt the files?

No, in order for the documents to be transferred to the DKMA system, we must be able to assemble and copy the content, and the files cannot be encrypted or password protected.


Can I save my data during the process/Can I stop and resume completing the forms on DKMAnet?

No, unfortunately the system does not allow for that. You are therefore recommended to have your documentation ready, in the same way as if you were sending your application by email. The required documents appear from the checklist; regarding the information you need to enter, please see the question: Which fields do I have to fill in myself in the forms on DKMAnet?


Why do I have to upload the EudraCT XML file?

You have to upload the EudraCT XML file because a lot of the information entered in EudraCT is reused in DKMAnet. Below you can see the fields that are filled in automatically with data from the EudraCT XML file and the fields you have to fill in yourself. When you use the service ”surveillance of an authorised clinical trial”, you do not have to upload a EudraCT XML file.


Which fields are filled in with data from the EudraCT XML file?

For each of the four services, you can see the data retrieved from the EudraCT XML file: New trial, Amendment, Surveillance and Notification.


Which fields do I have to fill in myself in the forms on DKMAnet?

For each of the four services, you can see the data that you have to fill in yourself: New trialAmendmentSurveillance and Notification.


How do I receive a reply to my application?

You will receive a reply by email sent to the contact email address indicated in the application/submission to the Danish Medicines Agency and the Scientific Ethical Committee System. 


How do I know that my application has arrived?

You will receive confirmation by email to the email address you provided under 'Applicant' (in the EudraCT form – email indicated for applicant in field C.1.4.6).

If you have used DKMAnet for companies with an employee signature, you can also look under the ’Submitted’ tab.


Why must files be attached in PDF format?

PDF files cannot be edited in the same way as Word documents. This means that applicants to a greater extent can rely on their submitted documents to remain unchanged.

Another advantage is that page layout, tables and other formatting is maintained in a PDF file. Finally, it eases the Danish Medicines Agency's case processing that all appendices are attached in the same format.


How do I handle documents with a file size of more than 10MB?

In the following link you can read about how you reduce the size of your documents. 


Why does the system only allow documents with a file size of maximum 10MB and applications with a total size of 80MB?

We have set the limit at 10 MB to avoid that very large files block the system and thereby prevent submission of applications. This is a common limit in various secure extranet systems.


Who can I contact if I need help?

If you have any questions about the functionality of DKMAnet, please contact DKMAnet support on +45 44 88 95 25 or at DKMAnet@dkma.dk

If you have questions about the ethical committee's requirements for applications for clinical trials, please contact the regional ethical committee's secretariat. You can find the telephone numbers of the regional committees here (under Select a committee). Link to DNVK.

If you have any questions about the Danish Medicines Agency's requirements for applications for clinical trials, please contact Clinical Trials on +45 44 88 91 23.


Is there a checklist for the Danish Medicines Agency and the Scientific Ethical Committee System?

Yes, please click this link


What is a signature page?

A form used for the sponsor's and the investigator's signature. As the investigator and the sponsor have joint responsibility towards the Scientific Ethical Committee System for submitting applications for clinical trials, both of them have to sign the application. The investigator must sign on the signature page (unless the sponsor and the investigator is the same person). The signature page must be attached to the application in DKMAnet. 

Read more about the individual steps in the form in the Step-by-step guidelines: New trialAmendmentSurveillance and Notification.


Substantial amendments – additional protocols

Is there a difference between amendments to the Danish Medicines Agency and additional protocols to the Scientific Ethical Committee System?

Yes, we have therefore made a list of amendments. The list shows which amendments you should send to the Danish Medicines Agency, the Scientific Ethical Committee System or both. The list is not exhaustive, and the sponsor/investigator is at any time responsible for submitting substantial amendments to the Danish Medicines Agency and/or the Scientific Ethical Committee System.

Read more about the individual steps in the form in the Step-by-step guideline: Amendment.


Surveillance

What does Surveillance cover?

You can submit the annual safety report, change of clinical trial status (e.g. has the trial been temporarily halted, ended earlier than planned or ended in Denmark or globally) or other safety-related information. See the guidelines about Surveillance.

Read more about the individual steps in the form in the Step-by-step guideline: Surveillance.


Notification

Is there a difference between notifications to be submitted to the Danish Medicines Agency and to the Scientific Ethical Committee System?

Yes, we have therefore made a list of notifications (and amendments) which is available here. The list shows which information you should send to the Danish Medicines Agency, the Scientific Ethical Committee System or both for notification purposes.

Read more about the individual steps in the form in the Step-by-step guideline: Notification.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.


...