Procedures for Project Amendments

Published 3.2.2020 
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  • Amendments that affect the conditions for approval of a project must be assessed by REC. The form used to apply for approval of project amendments can be found at 
  • An application for approval must be submitted for significant amendments to the project's purpose, methodology, duration or organisation (section 11 of the Health Research Act). Amendments of significance to the acceptability of the project, the safety and welfare of participants and general integrity - for example new information about risks and benefits - must also be notified.
  • REC will decide whether the project's approval shall continue under the new conditions.

  • Examples of project amendments: 
    • Changes in design and analysis
    • New information about the risks, inconvenience and/or benefit to the research participants and/or others
    • Change of Chief Investigator, Research Manager(s), Manager Responsible for the Research Biobank or Co-Investigators
    • Postponement or extension of the project duration
    • Increase in number of research participants
    • Changes to recruitment procedures
    • Changes to inclusion and exclusion criteria
    • Content-related change to invitation to participate (information material)
    • Changes in given conditions for dispensation from professional secrecy requirements
      (for example who is to have access to identifiable personal data)
    • Change to the storage and processing of personal health information or biological material
  • The Chief Investigator and Research Manager have an independent duty to assess the project's soundness, especially with regard to risk/benefit, and if necessary stop or change the project.
  • In acute situations where the research participants' safety is threatened, changes must be implemented immediately. The Project Amendment form must then be sent to REC.
  • Project documents must be marked with the date and version number. All changes from the original version must be marked, preferably using yellow highlighting. The 'track changes' and 'insert comment' functions must not be used. Such change marks are lost when the document is transferred to REC.
  • It may be necessary to complete a new project application if REC finds that the changes render this necessary.

  • An application shall not be submitted for changes that apply to:
    • Technical study material (participant cards, diary, medical bags etc.)
    • The number of research participants per centre where the total number of participants is unchanged
    • The principal tester in another country
    • The Contract Research Organisation (CRO)
    • The pharmaceutical, chemical or biological qualities of the trial substance