Clinical trials of medicines in humans

Updated 12 February 2016

Here you can find answers to questions about clinical trials in humans, amendments to authorised clinical trials, etc.

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1. What to be aware of when contemplating conducting a clinical trial

The Danish Ministry of Health has issued a 'Guide to getting started in clinical research' (available in Danish only), which provides information about planning and obtaining authorisation of clinical trials in Denmark.

The guide is primarily aimed at new researchers as well as PhD and masters students, but it could be of interest to many others.

The guide has been prepared as part of the Ministry's health plan called "Healthy Innovation – New innovation agenda in the health area" (information in Danish).


2. Does my clinical trial of medicines need the approval of the Danish Medicines Agency?

It is often difficult to find out whether or not a trial is to be classified as a clinical trial of medicinal products.

We address these difficulties by providing examples of what is and what is not a clinical trial in chapter 1 of our Guideline for applications for authorisation of clinical trials of medicinal products in humans.

We have also published a schematic guide that can help researchers find out quickly whether a trial is a clinical trial of medicinal products or possibly a non-interventional study.

Guide to assessing if a trial falls under the definition of a clinical trial


3. What must be included in an application for a new clinical trial authorisation?

In Chapter 3: Application (how to apply) of the guideline for applications for authorisation of clinical trials, we describe how to apply to the Danish Medicines Agency for authorisation to conduct a clinical trial.

Please also see Chapter 4: Contents of the application (e.g. the appendices to be submitted) for information about which appendices to submit with the application.

We have also compiled a checklist (Appendix 10) to help you find out which documents to submit with the application.

Risk-adapted assessment of clinical trials of already marketed medicinal products (Type A trials)

We offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.

Guidelines on application for authorisation of clinical trials falling under the risk-adapted assessment of already marketed medicinal products under the licensed indication

Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

The Voluntary Harmonisation Procedure (VHP) is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

For further information please see: Voluntary Harmonisation Procedure (VHP) for the assessment of multinational clinical trial applications

Clinical trials of medicinal products also testing medical devices non-CE marked for the intended purpose

Please follow this link for information in Danish only: Clinical testing of medical devices also testing medicinal products


4. How to submit the application to the Danish Medicines Agency

Application via DKMAnet

Companies, including CROs (Contract Research Organisations) engaged in clinical trials of medicines in humans can apply for authorisation of clinical trials and submit notifications about ongoing trials to DKMAnet, our access-controlled extranet: Applying for clinical trial authorisations via DKMAnet

Application on CD-ROM or via Eudralink

Applicants who do not have access to DKMAnet can send documentation electronically on CD-ROM or online via Eudralink. Clinical trial applications on CD-ROM or online via Eudralink


5. How will I know if an amendment to my clinical trial needs to be approved by the Danish Medicines Agency?

We receive many questions regarding which amendments to clinical trials are to be notified to the Danish Medicines Agency, in particular because the European guideline CT 1 has been revised.

We have therefore drawn up a list of which substantial amendments require our approval and which changes we must be notified of. The list also includes examples of changes that are neither subject to approval nor notification.

In brief, only substantial amendments are subject to approval, and the list provides examples of amendments that we consider substantial.

We request to be notified if the duration of a clinical trial is changed, if new sites are added, if the coordinating investigator, CRO or applicant changes, and when the trial is ended in Denmark.


6. How to report suspected unexpected serious adverse reactions (SUSARs) to the Danish Medicines Agency?

Guidance

Follow the link below for guidance on how to report SUSARs to the Danish Medicines Agency.

Reporting of adverse reactions in clinical trials

Form

We also have an e-form that can be used for reporting SUSARs if you do not use EudraVigilance.

Reporting of suspected unexpected serious adverse reactions seen in clinical trials (e-form)


7. Where can I get more information about the conduct of clinical trials of medicinal products in humans in Denmark?

At Clinical Trials Office Denmark, pharmaceutical companies and CROs can obtain contact information on potential collaboration partners in Denmark within 4 working days when they consider where to place a clinical trial. The Danish regions are responsible for the website Clinical Trials Office Denmark.

Contact:

You can write to Clinical Trials Office Denmark at clinical@clinicaltrialsdenmark.com

You can read more about Clinical Trials Office Denmark at www.clinicaltrialsdenmark.com

If you work with investigator-initiated trials, you can get more information from the GCP units


8. Trials notified before 1 May 2004

If you are the investigator of a clinical trial that was notified before 1 May 2004 and you need a form or other documents, please contact Clinical Trials on +45 44 88 91 23 or by email to kf@dkma.dk

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