12. november 2018

What documents to submit?

Below we explain which documents you must submit to the committee when you notify a health research project. Please be aware that different requirements apply for trials with or without medicines.

Document requirements for trials without medicines

Documents must be submitted as separate PDF files:

  1. Notification form duly signed by both the investigator and the sponsor
  2. Protocol in a Danish or English version
    • An international protocol must be supplemented by specific requirements in an appendix if the international protocol does not fulfil Danish legislation. The appendix must refer to the original project title listing date and version number.
    • Procedures for oral information as an integral part of the protocol
  3. Protocol summary
    • Must be in Danish
    • The layperson summary is a document specifically designed for non-medically experts. Therefore readability and use of plain language is important and technical terms should be avoided.
  4. Participant information
  5. Consent forms
  6. Questionnaires (may be included in a single file)
  7. Recruitment material (ads, posters, text on www.sundhed.dk or social media)
  8. Documentation of insurance cover (info in Danish) in case the Patient Compensation Association does not provide cover

    For medical devices:
  9. Danish version of relevant parts of the sponsor contract
    • Detailing particulars of publication, fees to researcher/trial subjects and the researcher's access to data

Formalities about the submitter

  1. Documentation of the identify of:
    • The principal investigator: Copy of health insurance card, registration ID or passport
    • For sponsors, if any: The company’s address and VAT no.
      Anyone having notified a project using digital signature need not submit documentation

  2. Documentation of the experience and education of the principal investigator
    • Resume and
    • Diploma or registration ID

Document requirements for trials with medicines

NOTIFICATION VIA THE COMMITTEE SYSTEM'S DATABASE

The documents must be submitted as separate PDF files.

  1. Notification form (duly signed by both the investigator and the sponsor)
  2. Protocol in a Danish or English version
    • An international protocol must be supplemented by specific requirements in an appendix if the international protocol does not fulfil Danish legislation. The appendix must refer to the original project title listing date and version number.
    • Procedures for oral information as an integral part of the protocol.
  3. Investigators’ Brochure (the summary of product characteristics may be used for marketed products)
  4. Protocol summary
  5. Participant information
  6. Consent forms and any authorities granted
  7. Questionnaires (may be included in a single file)
  8. Recruitment material, for example ads, posters, recruitment letters, text on www.sundhed.dk or social media.
  9. Documentation of insurance cover (info in Danish) in case the Patient Compensation Association does not provide cover.
  10. Danish version of relevant parts of the sponsor contract. Detailing particulars of publication and fees to researcher/trial subjects and the researcher's access to data.
  11. Copy of the notification to the Danish Medicines Agency (front cover) or receipt.
  12. Documentation of the experience and education of the investigators (for all investigators at all Danish sites).
    • Resume and
    • Diploma or registration ID.
  13. Documentation of the identity of the principal investigator and sponsor
    • For the investigator, this could be a copy of the health insurance card, registration ID or passport (in the case of foreign citizens).
    • For sponsors, the company’s address and VAT number must appear.
    • Anyone submitting the e-mail using digital signature with the duly completed application is considered adequately identified by the digital signature.
    • Anyone submitting the e-mail with the duly completed application is considered adequately identified by the digital signature.

NOTIFICATION VIA DKMANET (DANISH MEDICINES AGENCY)

It is possible for registered users of DKMAnet to submit a notification to both the Danish Medicines Agency and the committee system via DKMAnet. Follow this link to learn how.
What documents must be enclosed with a notification via DKMAnet?