The article outlines the key points to be included in the application for authorization to conduct clinical trials in Denmark.
Table of content
The Danish regulating authority in the sphere of healthcare products has published an application form to be completed by interested parties when applying for authorization to conduct clinical investigations involving medicines or medical devices in Denmark. The document provides an overview of the information to be included in the said application to ensure its completeness and facilitate the review process in general.
It is also important to mention that the form is based on the regulatory approach developed and adopted in the European Union for the purpose of further harmonization with the EU-wide regulatory framework for clinical investigations.
Scope of Application
First of all, it is stated that the application form should be completed in English or Danish for clinical investigations under the MDR. This includes investigations for non-CE marked medical devices or CE marked devices used for a different purpose to generate clinical data as part of a clinical evaluation for conformity assessment (CE marking).
Applications must be submitted via email to the Danish Medicines Agency (DKMA) and the Medical Research Ethics Committees (MREC) for simultaneous validation and assessment.
Submission details should include the following ones:
- First submission or resubmission status with corresponding dates and case numbers.
- EUDAMED CIV-ID number, if known.
- Confirmation if the clinical investigation is also submitted via CTIS as a clinical trial of a medicinal product.
Contact Information
The application should contain the details of a sponsor responsible for initiating, managing, and financing the clinical investigation.
In particular, the following details should be provided:
- Name, address, phone number, and email.
- Contact person’s details, including name, title, address, phone number, and email.
- Sponsor’s EU representative details if the sponsor is located outside the EU/EEC.
A monitor, independent of the investigation site, ensures the investigation follows the clinical investigation plan, good clinical practice, and legislation. The monitor must understand source documents in Danish or bring an independent interpreter.
The applicant should provide details of the monitoring institution, contact person, and confirmation of language proficiency. Details of the manufacturer responsible for the investigator’s brochure and statement of compliance should be provided as well, including contact person and regulatory compliance officer information.
For multicentre investigations, the coordinating investigator’s details must be provided.
Investigation Site Information and Principal Clinical Investigator(s) in Denmark
The applicant is expected to list all sites participating in the clinical investigation, including the institution name, address, principal investigator’s name, title, and contact information.
Investigation Sites Outside Denmark
If applicable, the applicant should provide information on other countries where the investigation is or will be conducted. Indicate if objections or supplementary comments have been raised by other competent authorities.
Clinical Evaluation Information
The application should contain brief information or reference to the clinical evaluation plan for the non-CE marked medical device, detailing how the investigation fits into the clinical development plan.
Expert Panel
The applicant should confirm if the manufacturer has consulted with an expert panel on the clinical development strategy and attach the expert opinion document if applicable.
Clinical Investigation Information
According to the guidance, the general information about the clinical investigation to be provided by the applicant should cover, inter alia, the following items:
- Official and Danish titles.
- Short title or acronym.
- Clinical investigation plan reference number, version, and date.
- Development stage (pilot, pivotal, post-market).
- Investigation type (exploratory, confirmatory).
- First-in-human status and prior human use.
- Investigational design and primary/secondary objectives and endpoints.
- Number of subjects (DK, EU/EEA, global), initiation and end dates, and main eligibility criteria.
Information on the Study Population
The applicant should also specify the study population, including healthy participants or patients, vulnerable populations, associated medical conditions, gender, and age range.
Medical Device Characteristics
The description of the medical device under investigation to be included in the application should cover:
- Product type, name, model, proposed class, CE marking status, and specific characteristics (e.g., sterile, active, software, invasive, implantable).
- Incorporation of medicinal substances or human/animal tissues and relevant components.
- Notified body details, if applicable.
Attached Application Documents
In addition to the above, the guidance also outlines the scope of additional documentation to be included in the application. As explained by the authority, such documents include the following ones: cover letter, application form, clinical investigation plan, synopsis, national addendum, participant information sheet, recruitment material, questionnaires, investigator’s brochure, GSPR checklist, statement of compliance, GDPR compliance description, principal investigator information, Danish version of sponsor contract, and proof of insurance cover.
Overview of Required Information in Investigator’s Brochure and Clinical Investigation Plan
In general, the submission should include the following information:
- Device identification and description.
- Intended purpose, risk classification, design, manufacturing, and previous generations.
- Manufacturer’s instructions, pre-clinical evaluation, existing clinical data, benefit-risk analysis, and safety information.
- Detailed clinical procedures, diagnostic tests, and monitoring plan.
- Statistical considerations, data management, amendments, and compliance statements.
Sponsor’s Declaration and Signature
The sponsor must declare awareness of obligations under Annex XV of the MDR, including:
- Conducting the study according to ethical principles, good clinical practice, and national legislation.
- Making the clinical investigation report publicly available in the EUDAMED database.
- Keeping documentation available for the DKMA for a specified period.
- Compliance with European data protection legislation (GDPR).
- Ensuring the accuracy and completeness of the information and documentation submitted.
Conclusion
In summary, the present guidance provides an overview of the information and documentation to be provided by the interested party when applying for authorization to conduct clinical investigations in Denmark. The document also provides additional clarifications and recommendations to be taken into consideration in order to ensure the completeness of the application and streamline the relevant review process.
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