Before applying for data

Before submitting your application to access data for a project, you must obtain the necessary permits.

If you will be working on The Secure Research Platform, you can apply for authorisation before applying for a project.

Read more about the The Secure Research Platform

Requirements for different project types

An application for data access to individual-level health data must contain the following:

  • Project description
  • Description of the data extraction
  • Order form
  • Valid approval stating that the project is included in the register of the data controller. Documentation must contain at least the following information:
    • Information about the institution which is the data controller
    • Information about the person in charge of the project
    • Title of the research project
    • Application deletion deadline, if possible

An application for data to be used in a questionnaire survey must contain the following:

  • Project description
  • Description of the data extraction
  • Order form
  • Valid approval stating that the project is included in the register of the institution, which is the data controller. Documentation must contain at least the following information:
    • Information about the data controller
    • Information about the person in charge of the project
    • Title of the research project
    • Application deletion deadline, if possible
  • Letter of invitation
  • The questionnaires you plan to distribute
  • Participant information, if this is distributed
  • Declaration of consent, if required

Applications for projects approved by The National Committee on Health Research Ethics must include the following:

  • Project description
  • Description of the data extraction
  • Order form
  • Valid approval stating that the project is included in the register of the institution, which is the data controller. Documentation must contain at least the following:
    • Information about the data controller
    • Information about the person in charge of the project
    • Title of the research project
    • Application deletion deadline, if possible
  • The most recent approved protocol to The National Committee on Health Research Ethics
  • The most recent approval of the project by The National Committee on Health Research Ethics
  • Valid approval from the Danish Medicines Agency, in the case of a clinical trial involving medicinal products.

Applications for data from medical records, and applications where information from medical records is to be linked to register data must contain the following:

  • Project description
  • Description of the data extraction
  • Order form
  • Valid approval stating that the project is included in the register of the data controller. Documentation must contain at least the following information:
    • Information about the data controller
    • Information about the person in charge of the project
    • Title of the esearch project
    • Application deletion deadline, if possible
  • Authorisation to retrieve data from medical records

Authorisation to retrieve medical records can be issued by the following:

  • The patient, by obtaining informed consent for the retrieval of data from patient records from all project participants. Please note that you must include an example of the consent form in your application.
  • The Danish Patient Safety Authority (only applies to projects that have applied for permission to retrieve records before the end of June 2020)
  • The regional council of the region where the person in charge of the project works (after June 2020)
  • A research ethics committee
  • Projects that necessitate the retrieval of medical records in connection with quality assurance or the development of specific treatments and workflows. Projects like these can make use of §42 d, section 2, subsection 2 of the Health Care Act as a legal basis for obtaining data from medical records, provided that the retrieval is done by an authorised healthcare professional.
    Please note:
    The top administrative management of the specific treatment facility from which you are retrieving medical data must approve the retrieval of medical records.
    The approval must be included in your application.
Contact

Research Services

Monday to Friday: 9.30-12.00

E: forskerservice@sundhedsdata.dk
T: +45 3218 3900