Netherlands CTIS Patient-Facing Document QC Checklist

Trial content checks

• The public title, protocol number, EU Clinical Trial number, sponsor and version date are correct.
• The purpose is stated in plain language and does not imply proven benefit.
• Trial arms, randomisation, placebo and comparator are described accurately.
• Screening, treatment, visits, calls, procedures, questionnaires and follow-up are complete.
• Research procedures are distinguished from normal care.
• The duration and number of visits match the protocol schedule.
• Main risks appear early, with fuller detail in the correct appendix.
• Unknown risks and burdens are not hidden in technical language.
• Expected direct benefit is described accurately. Healthy volunteers are told that direct benefit is absent.
• Alternatives to participation are explained when relevant.

Protocol-to-document consistency checks

• Inclusion populations match every information and consent document.
• Contraception, pregnancy testing, reporting and post-treatment periods match the protocol and investigator brochure.
• Stopping rules and follow-up after withdrawal match the protocol.
• Data and sample retention periods match the protocol, R1 form and biological-samples form.
• Optional future use is not described as a core trial procedure.
• The insurer, policy, coverage status and claims contact match Part II evidence.
• Participant compensation and reimbursement match the Dutch P1 form.
• The informed-consent process described in the protocol matches the harmonised recruitment and consent procedure template.
• Any use of medical records, a general practitioner, specialist or pharmacist is supported by an explicit consent statement.

Consent logic checks

• The core consent to join the trial is clearly identifiable.
• Optional choices use separate Yes or No responses.
• Refusal of future data use, remaining sample storage, future contact, DNA analysis or external travel support does not block trial participation.
• Trial-required data and samples are not presented as optional.
• The person who must consent is correct for age and decision-making capacity.
• The participant or representative receives enough time, can ask questions and receives a signed copy.
• The blank form is submitted in CTIS. Participant-signed forms are retained at site and are not uploaded with the application.
• Re-consent triggers are operational, including new safety information, a child reaching age 12 and recovery of capacity.

For the standard adult pathway, check the Netherlands patient information and consent requirements.

Population and document coverage checks

• Every population named in the protocol has an appropriate Dutch document.
• Participants aged 16 or older use the adult IVO pathway unless capacity or another special circumstance changes it.
• Children under 12 receive an age-appropriate discussion sheet and their parents or guardian receive the consent information.
• Children aged 12 through 15 receive their own information and consent document, in addition to parent or guardian consent.
• Adults lacking capacity receive information adapted to what they can understand, with a separate legal-representative form.
• Emergency enrollment has an authorised deferred-consent process and documents for the participant or representative at the earliest possible time.
• A witness pathway is available only where the participant understands but cannot complete ordinary written consent.
• Pregnancy follow-up distinguishes the trial participant from a pregnant partner who is a separate person.
• Healthy-volunteer documents cover absence of direct benefit, compensation, restrictions and relevant washout.

Use the detailed population guides for healthy volunteers, minors, limited-capacity participants and legal representatives, emergency enrollment, impartial witnesses and pregnancy follow-up.

Data privacy checks

• The document identifies the data collected and the purpose of each use.
• Coded or pseudonymised data is not called anonymous.
• The controller or joint controllers and data-protection contacts are correct.
• People who may see identifiable data are named by role.
• The Health and Youth Care Inspectorate access statement is accurate.
• Storage locations and fixed retention periods are clear.
• Transfers outside the European Union are described with safeguards.
• Withdrawal language distinguishes future collection from data already lawfully collected.
• External travel or reimbursement providers receive data only through a separate optional choice when applicable.
• Privacy wording matches the mandatory Dutch R1 form and the application-level GDPR statement.

Biological-sample and secondary-use checks

• Each sample, volume or procedure and its purpose is understandable.
• Trial testing is separated from remaining-sample storage and future research.
• Data and bodily material have separate optional consent choices.
• The future-research scope is defined by condition, treatment or another understandable field.
• The storage period is a fixed duration and does not say only "at least" a number of years.
• Sharing with other researchers and transfers outside the EU are explained.
• Withdrawal explains destruction of remaining samples and treatment of results already generated.
• Genetic analysis, artificial-intelligence analysis and commercial collaboration are described when applicable.
• The consent text matches the Part II biological-samples form.

Use the Netherlands secondary-use consent guide for the optional-consent structure.

Country-specific regulatory checks

• The participant information and consent form submitted for review is Dutch.
• IVO version 1.1, dated 14 August 2026, is used for a new adult document unless the permitted PIF transition is intentionally used.
• The IVO standard text is unchanged except where the instructions allow adaptation or deletion.
• The cover page is no more than two pages.
• The complete IVO is no more than 4,000 words, or an excess is justified in the cover letter.
• The text is written at B1 level and uses an accessible font at the model's minimum size.
• The general CCMO information references required by the IVO are preserved.
• The participant's insurance appendix is included unless an exemption was granted.
• Planned non-Dutch enrollment has an operational translation and certification plan.

Signature, version and administrative checks

• Every document has a unique title, version and date.
• The CTIS filename clearly identifies the population and Dutch language.
• The submitted consent forms contain blank participant, representative and researcher signature fields.
• Adult consent contains participant and researcher or authorised interviewer signatures and dates.
• Minor documents contain the correct child and parent or guardian signature blocks.
• Legal-representative documents identify the representative and relationship.
• Witness documents contain the required witness attestation and signature.
• Version dates match the cover letter and document list.
• Superseded or tracked-change drafts are removed from the final upload set unless a comparison is requested.

Readability and document-design checks

• The first two pages answer what participation involves, why the study is being done, main risks, time, payment, insurance and withdrawal.
• Headings are questions or statements a participant can understand.
• Sentences are short and medical terms are explained.
• Risk frequencies use consistent, understandable wording.
• Long protocol lists are replaced by participant-relevant summaries.
• Tables are used only when they simplify schedules or choices.
• Consent choices are visually distinct and cannot be skipped by mistake.
• Contact details are easy to find.
• Page numbers, appendix references and cross-references are correct.
• A Dutch lay reader from the intended population has reviewed the trial-specific wording where possible.

Final package review

Read the package once from the participant's perspective and once from the assessor's perspective. The first review tests comprehension and voluntariness. The second tests traceability to the protocol, national forms and CTIS categories.

Then compare the document list against the Netherlands Part II document checklist. Return to the Netherlands English CTIS hub for the complete guide series.