Norway CTIS Patient-Facing Document QC Checklist

Trial content checks

• Confirm the trial title, acronym, sponsor, EU trial number and participant group.
• State clearly that the project is research and identify the investigational treatment.
• Check randomization, blinding, placebo, treatment duration, visit schedule and invasive procedures.
• Describe foreseeable risks and burdens without minimizing uncertainty.
• State expected benefit accurately, including when no direct benefit is expected.
• Explain alternatives to participation where relevant.
• Confirm pregnancy testing, contraception, breastfeeding and partner precautions against the protocol.
• Check payments, expense reimbursement and injury-insurance wording against the Part II documents.
• Include relevant conflicts of interest or institutional connections.

Protocol-to-document consistency checks

• Match the population, age range, disease and inclusion pathway to the protocol.
• Match visit numbers, visit duration, home procedures, hospitalization and follow-up.
• Match sample types, volumes, timing, analyses and optional components.
• Match the protocol definition and expected date of the end of the clinical trial.
• Use realistic dates for the end of all research activity and data deletion.
• Ensure that the data deletion date is at least 25 years after the end of the clinical trial.
• Match safety contacts, emergency arrangements and withdrawal procedures.
• Check that every optional substudy is presented as optional.

Consent logic checks

• Identify the correct consent-giver for each population.
• Keep participation voluntary and free of waiver or liability-release language.
• Explain the right to refuse and withdraw without disadvantage or a need to justify the decision.
• Separate main-study consent from optional future use, extra samples and optional substudies.
• Show which consent choices can be accepted or refused independently.
• Leave the CTIS submission copy unsigned.
• At the consent visit, require signatures and dates from the participant or legal representative and the person conducting the interview.
• Provide a copy of the signed consent record to the participant or representative.
• If consent is electronic, describe secure identity verification in the recruitment procedure. REK KULMU identifies BankID or another two-factor method.
• If an impartial witness is needed, include the witness signature and attestation logic.

Population and document coverage checks

Confirm that the dossier includes every version needed for the protocol:

• the standard Norwegian adult Patient Information Sheet and Informed Consent Form
• a healthy volunteer variation, where healthy adults are enrolled
• age-appropriate forms under the Norway minor consent and assent pathway
• participant and representative versions under the limited-capacity consent pathway
• pre-approved documents for emergency enrollment
• an impartial witness process where a person cannot read or write
• separate information and consent for pregnancy follow-up where identifiable partner, pregnancy or infant data are collected
• a separate secondary-use or broad-consent form where optional future research is proposed

Data privacy checks

• Identify the controller or controllers and relevant contact details.
• Explain the categories and sources of personal data.
• Describe recipients, access and coding or pseudonymization.
• Explain transfers outside Norway and the European Economic Area where applicable.
• State retention and deletion periods consistently.
• Explain data handling after withdrawal without promising deletion where applicable law requires continued retention.
• Distinguish informed consent to trial participation from the legal basis for processing under the GDPR.
• Confirm that the separate Part II GDPR statement identifies its issuer and the party represented.

Biosample and secondary-use checks

• Identify every material collected and each planned analysis.
• Link trial samples to the protocol endpoints.
• State the storage location, storage period and responsible biobank.
• If samples remain in Norway for more than two months, identify the study-specific biobank.
• For export, state the country, purpose, storage period and destruction or return plan.
• For import, state the origin country and plan for residual material.
• Keep future research outside the main trial objective in a separate, optional broad-consent form.
• If a Norwegian general biobank will receive material, use its REK-approved consent.

Norway-specific recruitment checks

• Submit recruitment advertisements and identification materials in Norwegian.
• State who identifies candidates, who gives information and who obtains consent.
• Do not assign consent-taking to the treating physician where the dependent relationship could affect voluntariness.
• Where health records are searched to identify candidates, confirm that staff have legal access and describe any requested exemption from confidentiality.
• Exclude patient cards, thank-you cards and staff interview guides that do not identify or recruit participants.

Version, language and administrative checks

• Use Norwegian for consent forms and recruitment materials submitted for Norway.
• Keep other Part II documents in English unless a justified participant-language document is needed.
• Make the title, version and date identical in the file and CTIS structured fields.
• Use searchable, copyable PDFs rather than image-only scans.
• Prepare complete and redacted versions when CTIS publication rules require both.
• Remove names, signatures and other personal data from public versions.
• For an RFI revision, upload clean and tracked-change versions to the dossier itself.
• Verify that site and privacy contacts are current before first use.

For the underlying content rules, use the Norway patient information and consent guide. The Norway CTIS hub links the complete guide series.