Norway CTIS Patient Information and Consent Requirements

Language and document format

Mandatory. Submit the main information and consent documents in Norwegian. Write for a lay reader and adapt the information to the person who will consent. A legal-representative form cannot simply address the representative as though they were the participant.

Potential participants must receive material in a language they understand. REK KULMU does not ask to receive or assess foreign-language translations. The sponsor remains responsible for ensuring that a translation is accurate and corresponds to the approved Norwegian text. REK KULMU recommends a certified translator.

Use headings, short paragraphs, readable type and clear consent choices. Keep the EU trial number, document title, version and date visible. The version and date must match the CTIS structured data. Upload a searchable, copyable file rather than a scan.

Content of the Norwegian participant information

The form should explain, in plain Norwegian:

• that this is research and why the participant is invited
• the trial purpose, design, investigational treatment, randomization and blinding where relevant
• visits, examinations, treatment, invasive procedures and total participation period
• foreseeable risks, burdens, side effects and precautions
• expected benefit, including when no direct benefit is expected
• available alternatives to participation
• voluntary participation, the right to refuse and the right to withdraw without disadvantage
• pregnancy prevention, contraception, pregnancy testing and breastfeeding restrictions where relevant
• compensation, expense reimbursement and insurance arrangements
• confidentiality, data controllers, recipients, access, transfers and participant rights
• what happens to data and samples after withdrawal
• whom to contact about the trial, injury, participant rights and privacy
• the EU trial number and how results will become available

Consent to trial participation and the information required by data-protection law serve different legal functions. Do not state that the participant's CTR consent is automatically the GDPR legal basis for every processing activity. The separate sponsor statement in Part II must confirm GDPR compliance.

Norway-specific dates and retention information

Mandatory. State the expected date for the end of the clinical trial, normally the last participant visit or another protocol-defined end date. Also state the expected date or year when all research activity, including publication, will finish.

State the expected date or year for deletion of trial data. REK KULMU requires a realistic schedule and specifies that deletion must not be earlier than 25 years after the end of the clinical trial. The dates must allow enough time to meet the protocol endpoints.

Biological samples and biobanks

Conditional. If the trial collects biological material, explain what is collected, how it will be analysed and how long it will be stored. Identify any study-specific research biobank, its location and the responsible person or institution.

If samples are sent outside Norway for endpoint analyses or stored abroad, identify the destination country and storage period. Explain whether samples and residual material will be destroyed or returned after the active research period and provide the planned date or year.

Material stored in Norway for more than two months after collection must be placed in a study-specific biobank linked to the trial. Optional storage or use beyond the trial objectives needs a separate broad-consent pathway. The Norway secondary-use consent guide explains that distinction.

Conflicts, compensation and insurance

Mandatory. The Norwegian participant information must disclose relevant conflicts of interest or connections affecting those responsible for the study. Explain participant compensation and reimbursement without creating undue influence.

Describe the applicable injury coverage accurately. The Part II dossier separately includes a valid certificate from the Norwegian Medicines Liability Association and details of any additional trial-specific insurance.

Consent interview, signatures and copies

Give the participant enough time to consider participation and ask questions. The information-giver should be a qualified member of the research group. REK KULMU considers a treating physician's relationship with a patient to be dependent, including where future treatment is expected. Another person should obtain consent so that the decision is voluntary.

Mandatory when consent is obtained. The participant or legal representative and the person conducting the interview sign and date the form. Give the participant or representative a copy. No participant or investigator signature belongs on the blank form submitted in CTIS.

Conditional. Electronic consent may be used when the approved process provides secure identity verification. The recruitment procedure must state that electronic consent will be used. REK KULMU identifies BankID or another two-factor authentication method as an appropriate type of secure solution.

Population-specific versions

Prepare separate or clearly adapted documents when the standard adult form does not match the consent-giver or use case:

• healthy volunteer consent
• minor consent and assent
• limited-capacity participant and legal representative consent
• emergency enrollment consent
• impartial witness consent
• pregnancy follow-up consent
• secondary or future-use consent

Use the Norway patient-facing document QC checklist before submission. All Norway guides are listed on the Norway CTIS hub.