Modifications to an Approved Research Project

Substantial modifications to the trial protocol must be reported to an ethical committee in the form of a supplementary protocol. Modifications can only be implemented once the ethical committee has approved the supplementary protocol. The sponsor or the person responsible for the trial must take necessary safety measures to protect the trial subjects.

What are Substantial Protocol Modifications?

For example, changes could relate to:

  • Inclusion and exclusion criteria
  • Trial design
  • Number of trial subjects
  • Trial procedures
  • Trial medications
  • Dosage changes
  • Duration of treatment
  • Efficacy parameters
  • Modifications in trial responsible or trial locations
  • Content changes in the written information material for trial subjects, e.g., regarding side effects and risks
  • Modifications in sponsor contracts (regarding finance, data access, or publication).

The committee system has compiled a list of the most frequent modifications in a research project and which modifications are considered significant and thus require reporting. This list is not exhaustive, and the person responsible for the trial is always responsible for reporting substantial modifications to the committee system. Read here. (link to form – list of changes in approved projects).

If new information emerges during the trial regarding effectiveness, risks, side effects, complications, or disadvantages of the trial, or if there are significant changes to the trial's design, the trial subject must be informed, and renewed consent must be obtained (§ 16 in regulations on information and consent, etc.).


A supplementary protocol must be consistent with the main protocol. If modifications exceed the substantial modifications that can be approved in an existing project according to committee law, it is considered a new research project that must be reported independently. This might be the case, for example, if the purpose of the project changes, or there is a more extensive change in the trial's design.

Note on the difference between the main protocol and supplement (PDF)

If you are unsure whether the change can be considered a supplementary protocol, you should contact the committee that approved the original protocol.

How Do You Report Protocol Modifications?

The reporting of substantial modifications must be made to the committee that approved the original research project (committee law § 27, para. 2).

The trial responsible and sponsor must jointly report the modifications electronically using a digital signature.

You apply electronically by filling out a reporting form at the following link:

In addition, you must submit the following material in separate PDF versions to the competent ethical committee:

  1. A filled-out and signed modification notification form
  2. The revised trial protocol with clearly marked modifications/omissions to be approved (track changes), dated, and with a version number (if many and substantial changes necessitate a new version of the protocol)
  3. Any new material developed in connection with the current change
  4. Where modifications necessitate this, submit revised:
    • Written participant information/s
    • Procedure for providing oral participant information
    • Consent declarations. If there is a need to obtain new consent from the trial subjects, this should be described
    • Recruitment material
    • Any questionnaires.
    • New/revised documents should be dated and given version numbers, so they can be distinguished from previously approved versions.

The above should be sent to the competent ethical committee's email address, using a digital signature:

Find contact information for the regional ethical committees

Contact information for the national committee

Reporting a supplementary protocol/amendment to a medicinal trial can be done via the joint reporting portal DKMAnet (only for known users of DKMAnet). Further guidance on this can be found on The Danish Medicines Agency's website.

Case Handling of Supplementary Protocols

Supplementary reports are usually processed continuously in the committee system, so there are no deadlines for reporting supplementary protocols.

The committee system has a deadline for processing a properly formulated supplementary report of a maximum of 35 days.

Last updated 01-02-2024

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