Netherlands CTIS Part II Document Checklist

Application-level forms submitted with the Dutch dossier

Cover letter

Mandatory. Use the current European cover-letter template in the CTIS Form section. State the MREC proposed to assess the trial in the Netherlands. CCMO considers the proposal but can assign another qualified committee. The cover letter does not need to be signed at submission.

If the trial combines a medicinal product with a medical device or in vitro diagnostic, identify it as a combined study, include the relevant EU Clinical Trial and NL numbers, describe shared documents and address the coordinated Dutch process.

Invoice-details document

Mandatory. Submit the Dutch invoice-details template under Proof of payment of fee. The Netherlands invoices after submission, so advance proof of payment is not required. CCMO sends an online invoice, payable within 30 days. The form is not a Part II content document, but omitting it can make the Dutch application incomplete.

GDPR compliance statement

Mandatory. The sponsor or representative provides the European statement confirming that trial data will be collected and processed in accordance with Regulation (EU) 2016/679. Upload it in the CTIS Form section. It may be submitted without a signature.

Do not confuse this application-level statement with the separate Dutch R1 national data-protection form required in Part II.

Recruitment arrangements

Recruitment and informed consent procedure

Mandatory. Complete the harmonised European Recruitment and Informed Consent Procedure template and upload it under Recruitment arrangements. It covers the first act of recruitment, identification and approach of potential participants, access to identifiable records, consent setting, reflection time and special procedures for minors, adults lacking capacity, witnesses and emergencies.

The version 2.0 template is strongly recommended now and becomes the only accepted version for new Part II submissions from 1 September 2026. During the transition through 31 August 2026, the previous form remains accepted. There is no Dutch submission-signature requirement stated for this form.

Recruitment materials

Conditional. Submit every trial-specific advertisement or recruitment item addressed directly to potential participants under document code K2. Only the Dutch version is assessed. General institutional information that is not study-specific does not belong here. Recruitment items are blank materials at submission and are not signed.

Participant information and informed consent

Dutch Information Sheet for Research Participants and consent form

Mandatory. Submit the blank Dutch participant information and informed consent document under Subject information and informed consent form, document code L1. The authorised version is not signed at CTIS submission. When consent is obtained, the participant or representative and the researcher or authorised interviewer sign and date the applicable form.

For participants aged 16 and older, the new Dutch IVO model version 1.1, dated 14 August 2026, is strongly recommended. It becomes mandatory on 1 January 2027. The older PIF model may be used until that date. The reviewing MREC or CCMO assesses only the Dutch version. The Netherlands patient information and consent guide covers the document in detail.

Population-specific information and consent documents

Conditional. Prepare separate or adapted Dutch documents for every population and consent pathway in the protocol. This may include healthy volunteers, children, parents or guardians, adults lacking capacity, legal representatives, emergency enrollment, an impartial witness, pregnancy follow-up and optional secondary use.

Children under 12 need the age-appropriate discussion sheet and parent or guardian consent. Children aged 12 through 15 need an age-specific information and consent document plus the parent or guardian document. The Netherlands minor consent guide maps the age bands and signatures.

Other material integral to consent

Conditional. Upload a document under L2 only when it is an integral part of the informed consent process but is not itself the information and consent form. Examples can include a separate consent aid or an approved information appendix. Submit the Dutch version used with participants. It is normally blank at submission.

Questionnaires or diaries used to record trial endpoints are handled with the protocol rather than automatically placed in Part II. They should be described in the protocol and may be submitted under Protocol document code D4.

Investigator suitability

Principal investigator CV

Mandatory for every Dutch site. Submit a dated CV for the principal investigator under Suitability of the investigator. It must be no more than two years old. The official CV template is strongly recommended but not mandatory. Prefer an unsigned CV because CCMO does not require a signature and treats signatures as personal data.

Principal investigator declaration of interest

Mandatory for every Dutch site. Use the official declaration-of-interest template. Submit a separate dated declaration for the principal investigator at each site under Suitability of the investigator. The current European form does not require a handwritten signature and the Netherlands adds no signature requirement.

Only add a site when both investigator documents and the signed VGO are ready. A temporary change of principal investigator is submitted as a Part II substantial modification with the temporary investigator's CV and declaration.

Site suitability

Site Suitability Declaration, VGO

Mandatory for every Dutch site. Submit the signed front sheet of the official Site Suitability Declaration, known as the Verklaring Geschiktheid Onderzoeksinstelling or VGO, under Suitability of the facilities. This also applies to a single-centre trial. The executive board or management of the institution signs it. A validated digital signature is accepted.

The VGO is available in Dutch and English, and the institution may choose either version. A separate VGO is required for each site. A new VGO is not needed solely because the site's principal investigator changes.

The related Clinical Trial Agreement supports local feasibility but is not uploaded in CTIS. Local permission and contracting continue outside the CTIS authorisation process.

Insurance and indemnification

WMO participant-insurance certificate

Mandatory unless an exemption applies. Submit proof that participants are insured against damage caused by participation. Coverage must comply with the Dutch Medical Research (Human Subjects) Compulsory Insurance Decree 2015 and cover the whole trial.

Conditional. For a qualifying low-intervention trial, include a reasoned request for exemption instead of presenting the exemption as automatic. Government-appointed institutions can fall within statutory exceptions. The information sheet must accurately explain whether insurance applies.

Sponsor or investigator liability cover

Mandatory. Liability cover or another adequate financial guarantee must be in place for the sponsor or executing party. If this is not already evidenced through the submitted documentation, provide separate proof under Proof of insurance cover or indemnification. Liability protection remains required even where participant insurance is exempt, apart from the specific statutory government exception.

Financial and other arrangements

Dutch compensation, funding and arrangements form

Mandatory. Use the national P1 template to describe funding, payments to the investigator or site, participant compensation, reimbursements and other arrangements. Submit it under Financial and other arrangements. The template also addresses the Dutch review points on publication and early termination that were previously considered through the clinical trial agreement.

For healthy volunteers, describe compensation transparently. Dutch guidance links the amount to time and burden, with the reviewing committee assessing whether it is appropriate. The Netherlands healthy volunteer consent guide explains how this should align with the participant document.

National data protection

Dutch R1 data-protection form

Mandatory. Complete the national R1 template and upload it under Compliance with national requirements on data protection. The current official form is dated 16 January 2026 and is available in English. It is separate from the GDPR statement in the CTIS Form section.

Participant-facing privacy text still belongs in the Dutch information and consent document. It should identify the data used, controllers, access, coding, storage period, transfers, rights, relevant contacts and any optional secondary use. Pseudonymised data remains personal data under the GDPR.

Biological samples

Compliance with biological-sample rules form

Conditional on sample collection, storage or future use. Complete the official biological-samples template under Compliance with use of biological samples. The Dutch form is aligned with the EudraLex Volume 10 template. Describe collection, storage, transfer, analysis, destruction and any future use.

If future use is optional, present it as a separate choice from trial participation and distinguish data from bodily material. The Netherlands secondary-use consent guide explains the Dutch IVO wording and withdrawal logic.

Final submission checks

• Confirm that every Dutch site has a CV, declaration of interest and signed VGO.
• Submit only the Dutch participant information, consent and recruitment materials for Dutch ethical assessment.
• Use the current mandatory national templates rather than sponsor substitutes.
• Keep the EU Clinical Trial number, document version and date consistent.
• Submit blank consent documents at application. Do not upload participant-signed forms.
• Make uploaded documents searchable where possible.
• Check that the protocol describes every consent pathway used in the trial.
• Confirm that the insurance, P1 form, IVO and protocol state the same compensation and coverage arrangements.
• Complete both the application-level GDPR statement and the Dutch Part II R1 form.

For a focused content and consent review before upload, use the Netherlands patient-facing document QC checklist. Return to the Netherlands English CTIS hub to select another guide.