Sweden CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

Confirm that the participant information accurately states the trial purpose, interventions, visit schedule, duration, procedures, risks, inconveniences and expected benefits. Where no direct therapeutic benefit is expected, the wording should not imply one.

Confirm that the EU trial number is present and that the participant is told how trial results can later be located in the EU database.

Check that the right to refuse and the right to withdraw at any time without negative consequences are stated clearly.

Protocol-to-patient-document consistency

Compare every participant-facing statement against the current protocol version.

Check:

• visit frequency and expected duration
• invasive procedures and sample collection
• randomisation, placebo or comparator descriptions
• pregnancy testing and contraception
• treatment interruption and withdrawal procedures
• emergency enrollment if applicable
• remote or decentralised activities if applicable
• safety follow-up after treatment discontinuation
• planned future use of samples or data

Any meaningful difference should be resolved before submission rather than explained later in a request for information.

Consent logic checks

Confirm that the consent form has signature and date fields for the participant or legally designated representative and the person providing the information.

Confirm that the protocol and Part II procedure identify who obtains consent. In Sweden, the normal rule is a licensed physician or licensed dentist. If another healthcare professional is proposed, check that special reasons are documented and that the required Läkemedelsverket exception is addressed.

Do not sign the submitted CTIS copy. The blank approved form is uploaded. Trial signatures are collected when consent is obtained.

Population and document coverage

Map every protocol population to a specific Swedish information and consent pathway.

• Main adult participants: Sweden patient information and consent requirements
• Healthy volunteers: Sweden healthy volunteer consent requirements
• Minors: Sweden minor consent and assent requirements
• Adults without decision-making capacity: Sweden limited-capacity consent requirements
• Emergency enrollment: Sweden emergency enrollment consent requirements
• Participant unable to write or sign: Sweden impartial witness requirements
• Pregnancy follow-up: Sweden pregnancy follow-up requirements
• Optional future use: Sweden secondary use consent requirements

For minors, specifically verify whether the trial may include participants aged 15 to 17. If they understand what participation means, Swedish law requires their own informed consent in addition to guardian consent.

Data privacy checks

Make sure participant-facing privacy information matches the actual study data flow. Check the identity of relevant controllers, categories of data, transfers, access, retention and participant rights against the approved data-protection documentation.

Avoid internal contradictions. A participant-facing promise such as permanent deletion on request should not be made if the protocol, safety obligations or legal record-retention requirements do not support it.

Biological-sample and future-use checks

Where samples are involved, verify that the participant information matches:

• the protocol
• the CTIS biological-sample compliance document
• the Swedish biobank application where the Biobank Act applies
• sample destinations and planned analyses
• retention period or retention logic
• current-study use
• any optional future-use purpose
• withdrawal or restriction choices

Swedish Biobank Act rules distinguish the purpose already covered by the authorised study from a genuinely new purpose. Do not use broad future-use language as a substitute for the information and consent process required for the later use.

Compensation and insurance checks

Confirm that reimbursement, compensation and injury protection in the participant information match the Part II financial and insurance documents.

For incapacitated participants and their representatives, remember that the CTR prohibits incentives or financial inducements beyond compensation for expenses and loss of earnings directly related to participation.

Signature, version and administrative checks

Confirm that each Swedish document has a controlled title, version and date. The version should match references in the protocol and Part II procedure.

Check that the correct blank form is uploaded for each population. Remove accidental site signatures, participant signatures or completed personal data from the submission copy.

Ensure recruitment advertisements and participant-facing material are in Swedish.

Readability and language checks

Swedish must be understandable to the intended participant population, not just grammatically correct. Define clinical terms, shorten dense sentences and keep the decision-relevant information visible.

The language requirement covers more than the ICF. Swedish law requires Annex I points 59 to 73 to be in Swedish, and Läkemedelsverket expects participant-directed documents to be Swedish.

Final package check

Before submission, compare the patient-facing set against the Sweden Part II document checklist. Then review the entire package once from the participant's perspective and once from the assessor's perspective.

Return to the Sweden CTIS Part II hub for the full guide cluster.