Electronic clinical trial applications do not meet format requirements
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility.
Unfortunately, we receive quite many applications that do not comply with the requested format. The most common error that we see is that several files are submitted in various formats (PDF, Word and emails).
This delays the start-up phase of our review, and we therefore call attention to the description of the requested format.
In the event that it is not possible to submit one PDF file with bookmarks, we accept the submission of separate PDF files for each of the submitted documents with unambiguous file names (e.g. "Cover letter", "Protocol", "EudraCT application form", etc.).
If you use Eudralink to submit several files, please send them in one ZIP file.
For More Information Please click here: Danish Medicines Agency e-CTA
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