Norway CTIS Part II Guides

Choose the right Norway guide

• Norway CTIS Part II document checklist
  Use this first to identify the standard, site-specific and conditional documents for a Norwegian application.
• Norway patient information and consent requirements
  Use this to prepare the main Norwegian Patient Information Sheet and Informed Consent Form.
• Norway patient-facing document QC checklist
  Use this before submission to check protocol consistency, consent logic, privacy, samples, readability and document control.
• Norway healthy volunteer consent requirements
  Use this when participants have no condition that could provide a therapeutic benefit from the investigational treatment.
• Norway minor consent and assent requirements
  Use this for children, adolescents and their guardians, including Norway's under-12, 12-to-15 and 16-to-17 pathways.
• Norway limited-capacity and legal representative consent requirements
  Use this when an adult cannot provide legally valid informed consent.
• Norway emergency enrollment consent requirements
  Use this when the protocol proposes enrollment before prior consent under Article 35 of the Clinical Trials Regulation.
• Norway impartial witness consent requirements
  Use this when a participant or legal representative cannot read or cannot write and the consent process needs an impartial witness.
• Norway pregnancy follow-up consent requirements
  Use this when the protocol collects pregnancy, maternal, outcome or infant information from a participant or a participant's partner.
• Norway secondary-use consent requirements
  Use this for optional future research involving data or biological material beyond the approved trial objectives.

The main Norway-specific differences

REK KULMU recommends the European Commission Part II templates and publishes national consent templates. At CTIS submission, consent documents are blank. Participants and the person conducting the consent interview sign and date them later, when consent is obtained.

Norwegian consent documents must give realistic dates for the end of the clinical trial, completion of all research activity and deletion of data. The deletion date must allow at least 25 years after the end of the clinical trial. Biological-sample information must identify the material, analyses, storage period, biobank arrangements and any transfer outside Norway. The main Norway consent guide explains these national content points.

Norway also has operational rules that affect Part II preparation. Recruitment materials are submitted in Norwegian. Consent should not be obtained by the participant's treating physician where the dependency could compromise voluntariness. Electronic consent must use a secure identity solution such as BankID or another form of two-factor authentication.

For each Norwegian site, submit the principal investigator's curriculum vitae and conflict-of-interest information. The site suitability form must be issued by a head of department, head of clinic or equivalent institutional representative who is not the principal investigator. A valid insurance certificate from the Norwegian Medicines Liability Association is required.

Other language versions

Read the Norwegian CTIS Part II guides.