DKMAnet: Clinical trials - questions and answers

What advantages will I gain from using DKMAnet for applications for and reporting of clinical trials?

The DKMAnet gives you the possibility of attaching appendices directly to the application, so you don't have to send them by regular mail or burn them to a CD-ROM (provided that the individual file size does not exceed 10 MB).

It also provides better data safety, as you are working on an encrypted connection. Finally, the PDF file available under Submitted at the DKMAnet immediately gives you documentation for your submission.

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Will I also get replies to clinical trial applications via DKMAnet?

Not at the present point in time. Replies to applications are sent to the contact email indicated in the application/reporting.

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Who can submit applications and updates concerning clinical trials via DKMAnet?

To get access to application forms concerning clinical trials at the DKMAnet, a company must have an appointed Security Administrator, who can then delegate the right to use DKMAnet to company employees.

Thus, it is up to each company to decide who is to have access to submit material on clinical trials. For further information, please see Questions and answers about access to DKMAnet.

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Can I find previously submitted applications/amendments?

Yes. The menu Submitted gives you access to PDF versions of previously submitted material.

Please note that you cannot open any attached documents.

You can see the file name of attached documents, but the DKMAnet does not store any such files.

It is not possible to download applications or other documents not submitted via the DKMAnet.

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Can investigators at hospitals also use the DKMAnet to submit clinical trial applications?

Yes, investigators at hospitals can use the DKMAnet for clinical trial applications.

Investigators are created as DKMAnet users by means of a slightly different procedure than company users. If you would like to know more, please contact the Danish Health and Medicines Authority's DKMAnet support at dkmanet@dkma.dk/+45 4488 9525.

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Why must files be attached in PDF format?

PDF files cannot be edited in the same way as Word documents. This means that companies 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 Health and Medicines Authority's case processing that all appendices are attached in the same format.

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

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

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Why can't I submit documents that are larger than 10MB?

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.

Appendices that are larger than 10 MB should be submitted on another electronic media, such as a USB stick or a CD-ROM.