Where Should I Apply?

This question is crucial for understanding which type of application you need to submit. If you are planning an entirely new trial, you will likely have to go through the entire approval process from the beginning. However, if you wish to make changes to an already reported trial, you may need to submit a supplementary application instead, focusing on the specific changes you want to implement.

This question will help determine which regulatory and ethical guidelines your trial must comply with. Trials involving pharmaceuticals must follow both national and international guidelines, including the EU's Clinical Trials Regulation (CTR), and are reported via CTIS. Trials involving medical devices must comply with the MDR (Medical Device Regulation) and require specific approval processes and risk assessments. Trials with IVD devices must comply with the IVDR (In Vitro Diagnostic Regulation), which also has specific requirements for approval and risk assessment. If your trial does not involve any of these, the approval process may be less complex but still require ethical evaluation.

All pharmaceutical trials must be reported through the European reporting platform CTIS (Clinical Trials Information System). This is a mandatory step to ensure that your trial complies with both Danish and European legislative requirements. Reporting through CTIS ensures a uniform assessment and makes international collaboration easier. It is crucial to follow the correct protocols to avoid legal complications and to maintain the ethical standard in research. Follow the link below to read more about this process.

Reporting Clinical Trials under the Clinical Trials Regulation (CTR) 

This question is essential for determining whether the medical equipment you plan to use in your trial already complies with the EU's regulations for product safety and quality. A CE mark indicates that the product has undergone and passed a series of tests and meets the required standards. If your equipment is CE marked, it may simplify the reporting process and the subsequent steps in your research project. If the equipment is not CE marked, additional approvals and assessments will likely be necessary.

If your trial falls into categories that require reporting to The NVK (National Scientific Ethical Committee), it is crucial that you follow the correct procedures for reporting. Follow this link for more information on reporting SDV cases as well as relevant requirements and guidelines.

Report an SDV trial

All other trials that do not involve drugs, medical devices, and are not a health data science project, must be reported to your Regional Scientific Ethical Committee. Reporting to the Regional Scientific Ethical Committee is essential to ensure that your trial is in compliance with local ethical guidelines and legislation.

For contact information and further information about the RVK

Go to The Regional Scientific Ethical Committees

This question is designed to determine whether your trial or study is designed to maintain the current approval and labeling of a product or treatment. Trials with this purpose are typically subject to less stringent regulatory requirements, but it is still necessary to comply with ethical guidelines and relevant laws. Understanding the purpose of your trial will help to determine the necessary process for reporting and approval.

This question is essential to understand whether your trial is designed to obtain CE marking for a specific piece of medical equipment. Trials with this goal are subject to a number of specific regulatory requirements and must go through an extensive approval process. Obtaining CE marking involves a thorough evaluation of the product's safety and effectiveness. If this is the purpose of your trial, you should prepare for a more complex reporting and approval procedure.

If your trial is subject to Article 62, you are obligated to submit your application to both The Medical Research Ethics Committees (The MREC) and The Danish Medicines Agency. Article 62 pertains to trials with specific regulatory and ethical requirements. Fulfilling the reporting obligation to both authorities is crucial to ensure that your trial meets all the necessary legal and ethical standards.

Click here for further information and the application form.

Report clinical trials of medical devices under MDR

If your trial is categorized under Article 82, you must submit your application to The Medical Research Ethics Committees (The MREC). Submitting an application to The MREC is mandatory to ensure that your trial complies with the relevant ethical and legal guidelines.

Click here for further information and the application form.

Report clinical trials of medical devices under MDR

If you conduct clinical follow-up studies of medical devices that are already marketed and that would otherwise be subject to reporting to an ethics committee, you must submit a notification to the Essential Medical Scientific Committees (MRECs). Additionally, if your study involves procedures that are more burdensome or invasive than what the CE marking covers, you are also required to notify the Danish Medicines Agency under Article 74.1. If you are unsure of what qualifies as 'burdensome' or 'invasive' procedures, it is recommended to contact the Danish Medicines Agency directly.

Click here for more information as well as the application form.

Report clinical trials of medical devices under MDR

This question is central to determining whether your trial is intended to extend the scope of application for a CE-marked medical device. If so, there will be specific regulatory guidance and ethical standards that your trial must comply with. A trial with this intent will often require a more comprehensive reporting and approval process, as it could potentially involve a broader patient population or new application areas for the device in question.

If your trial is intended to test a CE-marked medical device outside of its current intended use in order to extend the CE marking, you are required to report it to both the Medical Research Ethics Committees (MRECs) and the Danish Medicines Agency under Article 74.2.

Click here for further information and an application form.

Report clinical trials of medical devices under MDR

If what you are planning does not qualify as research in the traditional sense, then your study is not subject to assessment by a scientific ethical committee. This may be the case if your work primarily focuses on internal quality assurance processes, administrative improvements, or other non-research activities. Although your study does not require ethical approval, it is still important to comply with relevant guidelines for data handling and privacy. Contact us if you are in doubt, to ensure that you are following the correct procedures.

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Modifications to drug trials must be reported in CTIS. It is important to distinguish between a significant or insignificant change. For specific information about this process, you can visit the link below.

Report modifications to drug trials under CTR

Modifications to medical device trials must be reported to the originally approving committee. It is important to distinguish between substantial and non-substantial modifications. Visit the link below for specific information about this process.

Report modifications to medical device trials under MDR

Modifications to SDV cases or dispensation cases must be reported to the originally approving committee. It is important, among other things, to distinguish between substantial and non-substantial modifications. Visit the link below for specific information about this process.

Modifications to an approved research project

Modifications to an approved research project must be reported to the originally approving committee. It is important, among other things, to distinguish between a substantial and non-substantial modification. Visit the link below for specific information about this process.

Modifications to an approved research project

If your clinical trial concerns medical equipment for in vitro diagnostics with the purpose of obtaining or expanding CE marking, it is necessary to submit a report to both the Medicinal Research Ethics Committees (MREC) and The Danish Medicines Agency. This requirement follows from the regulation's Article 58(1) and Article 70(2).

To ensure that your trial complies with all relevant regulatory requirements, refer to further guidance and the associated application form under our section

Report study of medical equipment for in vitro diagnostics under IVDR

Does your performance study of IVD equipment under IVDR aim to get the equipment CE marked or to expand the CE marking?

This question determines whether your study of IVD equipment is a clinical follow-up study. Clinical follow-up studies focus on monitoring and evaluating the performance and safety of already CE-marked medical equipment after its introduction to the market. Such studies are important for ensuring long-term data about the equipment's effectiveness and safety in real-world scenarios. If your study falls under this category, it must comply with specific regulatory requirements and guidelines for clinical follow-up studies.

Modifications to medical device trials for in vitro diagnostic devices must be reported to VMK. Visit the link below for specific information about this process and relevant application forms.

Modifications to approved performance studies under IVDR

This step in your research project requires that you report to the Medicinal Research Ethics Committees (MREC) for approval. Additionally, it may be necessary to notify The Danish Medicines Agency, depending on the nature and scope of your project.

Read more here

Report study of medical equipment for in vitro diagnostics under IVDR

If you are unsure whether your trial needs to be reported or not, and to whom it should be reported if this is the case, please contact us by phone or email.

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If your research project involves extensive mapping of the genome and you are seeking an exemption from the requirement for renewed consent, the project must be reported to The National Scientific Ethics Committees (The NVK). This is especially the case if you are using biological material from previously approved research projects or from clinical biobanks.

Methods such as whole-genome sequencing, exome sequencing, RNA sequencing, and other epigenetic studies involving extensive DNA sequencing fall under this category.

The NVK's assessment of exemption applications takes into account several factors, including the purpose of the project, previous informed consent, the status of the subjects, and potential health risks that may arise from secondary findings.

For further information and guidance on exemption applications, including document requirements and standards for consent declarations, refer to the following page.

Read about and report a research project with extensive mapping of an individual's genome, in which an exemption from the consent requirement is sought

This question helps to identify whether your research project falls under the category of 'particularly complex areas', which require reporting to The National Scientific Ethics Committees (The NVK). Particularly complex research areas include projects that deal with extensive mapping of the genome, health data science research projects without biological material, but with existing genomic or imaging data. It also includes projects involving psychosurgery or research on deceased persons.

If your research project falls under the particularly complex areas as described in the guidelines from the Medical Research Ethics Committees, you must report it to The National Scientific Ethical Committees (The NVK). This includes projects involving extensive genetic mapping, health data science without biological material, psychosurgery, and research on the deceased. Reporting to The NVK ensures that your project undergoes the necessary ethical and scientific assessment, appropriate to its complexity and sensitivity.

Click here to read more.

Reporting Other Types of Trials to NVK

Some types of health science research projects do not require reporting to the scientific ethical committees. This includes:

• Survey and interview studies without human biological material.
• Registry research projects based on pure data (letters, numbers, symbols, etc.), unless it is a health data science project.
• Research projects with anonymous human biological material that cannot be attributed to specific individuals.
• Experiments on non-embryonic cell lines originating from previously approved collections of cells or tissues.
• Non-intervention studies with drugs, as defined in relevant legislation.
• Patient treatment or treatment trials.
• Quality assurance or quality control.

Does your trial fall into one of these categories?

This question determines under which regulatory regime your drug trial is reported. 'CTR' refers to the EU's Clinical Trials Regulation, which is the latest legislation for clinical trials in the EU. 'The Directive' refers to the older EU Directive on clinical trials. Where the trial is reported also determines where and how changes are to be processed.

This question is crucial for determining which ethics committee - the Medical Research Ethics Comittees (MREC) or the Regional Research Ethics Committees (RVK) - you should submit any modifications to your research project to. MREC handles particularly complex cases, while RVK covers ordinary health science projects. Correct identification of the original review committee is essential, as all significant modifications to the research project must be reported to the committee that originally approved the project.

If your ongoing drug trial was reported before January 31, 2022, any additional protocols or modifications must be reported to the Medical Research Ethics Comittees (MREC) that originally approved the trial. This applies during a transition period of 3 years. After January 31, 2025, ongoing trials must be administratively transferred to and approved under the new rules of the EU's Clinical Trials Regulation. Modifications to drug trials may also need to be reported to the Danish Medicines Agency.

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Ongoing trials under the Directive and Addendums

If your ongoing research project requires significant modifications to the trial protocol, these must be reported to the Regional Reseach Ethics Committee (RVK) that originally approved the project. This includes modifications that could affect the safety of the trial participants, the implementation of the research project, or the interpretation of the scientific data. The notification must be made electronically with a completed and signed change notification form as well as all relevant material. It is important that these modifications are approved by RVK before they are implemented.

Get more information here.

Modifications to an ongoing research project