From 24. marts 2014 it will be possible for users of DKMAnet to submit clinical trials of medicinal products via the Danish Health and Medicines Authority's DKMAnet.
Problems with applications via DKMAnet
Unfortunately, you may experience problems when you are sending clinical trial applications etc. via DKMAnet to the research ethics committee system
Consequently, we recommend that you send notifications of projects directly to the research ethics committee, in the same way as with non-medical trials.
However, if you prefer to use DKMAnet, please contact the relevant committee to make sure that they have received your notification.
This common reporting portal makes it possible for researchers and companies to submit just one application via DKMAnet. Once submitted, DKMAnet takes care of sorting and distributing the content and attached documentation between the Danish Health and Medicines Authority (DHMA) and the committee system (REC). The review process then runs in parallel and independently in the two authorities.
During 2014, it will become mandatory to submit all clinical trial applications via DKMAnet.
On DKMAnet, you will find further submission instructions together with a list of documents required when making a submission. When you make a submission, you will also have the possibility to advertise for trial participants using a new recruitment portal on Sundhed.dk.
The common reporting portal can be used for
- Applications for new projects
- Amendments of authorised projects
- Annual reporting of side effects
- Final study reports.
- Signature page
- Classification codes: Group of diseases and
- Department classifications
- Document checklist (common for DHMA and REC)
- Amendements to clinical trials on medicinal product
- Template for advertising through Sundhed.dk
The committee system's requirements for trial protocols and appendixes
To find out what needs to be included in the protocol, please see section 5 of the Danish Health and Medicines Authority's guidelines: Guideline for applications for authorisation of clinical trials of medicinal products in humans.
Next, you will need to consult the committee system's checklist for clinical trials of medicinal products regarding the supplementary requirements imposed by the committee system.
Further guidance on the committee system's requirements is provided in our Guidelines about notification, submission duty (health-scientific research projects):
- Clinical trials of medicinal products (trial participants with capacity)
- Clinical trials of medicinal products (trial participants with incapacity)
- Clinical trials in emergency situations
Where relevant, use tools or standard documents (some are in Danish only):
- Template (information for participants and guidelines for giving oral information)
- Standard forms (consent forms)
- The rights of trial subjects
- Authorisation between parents