Netherlands CTIS Part II Guides

Choose the right Netherlands guide

Netherlands CTIS Part II Document Checklist

Use this first to identify the national forms, site documents, insurance evidence and participant documents needed for a Dutch application.

https://trialagents.com/ctis/netherlands/en/part-ii-document-checklist

Netherlands Patient Information and Consent Requirements

Use this guide to prepare the main Dutch participant information sheet and informed consent form for participants aged 16 or older.

https://trialagents.com/ctis/netherlands/en/patient-information-consent-requirements

Netherlands Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, consent logic, privacy text, population coverage, readability, signatures and version control.

https://trialagents.com/ctis/netherlands/en/patient-facing-document-qc-checklist

Netherlands Healthy Volunteer Consent Requirements

Use this for Phase I and other trials involving healthy volunteers, including compensation, restrictions, screening, risk language and absence of direct benefit.

https://trialagents.com/ctis/netherlands/en/healthy-volunteer-consent-requirements

Netherlands Minor Consent and Assent Requirements

Use this for participants under 16. It explains the Dutch age bands, parent or guardian signatures, age-appropriate information, resistance and consent changes at age 12.

https://trialagents.com/ctis/netherlands/en/minor-consent-assent-requirements

Netherlands Limited-Capacity and Legal Representative Consent

Use this when adults cannot make a reasonable decision about trial participation and a legally designated representative must consent.

https://trialagents.com/ctis/netherlands/en/limited-capacity-legal-representative-consent-requirements

Netherlands Emergency Enrollment Consent Requirements

Use this for trials that may enrol a participant without prior consent during a sudden life-threatening or other sudden serious medical emergency.

https://trialagents.com/ctis/netherlands/en/emergency-enrollment-consent-requirements

Netherlands Impartial Witness Consent Requirements

Use this when a capable participant understands the trial but cannot complete written consent in the usual way and an impartial witness may be needed.

https://trialagents.com/ctis/netherlands/en/impartial-witness-consent-requirements

Netherlands Pregnancy Follow-Up Requirements

Use this to prepare consent and privacy wording for pregnancy follow-up involving a pregnant participant or the pregnant partner of a trial participant.

https://trialagents.com/ctis/netherlands/en/pregnancy-follow-up-requirements

Netherlands Secondary Use Consent Requirements

Use this for optional future research with coded data or remaining biological samples, including separate choices, scope, storage, sharing and withdrawal.

https://trialagents.com/ctis/netherlands/en/secondary-use-consent-requirements

Main Netherlands differences

Dutch participant documents

The Dutch committee assesses only the Dutch information sheet and consent form. A participant who does not understand Dutch must still receive written and oral information in a language they understand. The sponsor remains responsible for an accurate translation that matches the authorised Dutch version.

The Netherlands introduced the Information Sheet for Research Participants, called the IRP in English and the IVO in Dutch, for participants aged 16 and older on 1 June 2026. Version 1.1 is dated 14 August 2026. Use is strongly recommended now and becomes mandatory on 1 January 2027. Until then, the previous Subject Information Sheet, called the SIS in English and PIF in Dutch, remains permitted. The Netherlands patient information and consent guide explains how to use the current model.

Integrated national review

One qualified MREC or CCMO assesses both Parts I and II. CCMO directly reviews certain trial types, including medicinal-product research involving pregnant or breastfeeding participants. CCMO's National Clinical Trial Office validates the application and considers the sponsor's proposed MREC, but may assign another committee based on competence, timing or expertise.

Mandatory national forms

The Netherlands requires a signed Site Suitability Declaration, known as the VGO, for every Dutch site. It also requires national templates covering compensation, funding and other arrangements, and compliance with national data-protection requirements. The official declaration-of-interest template is mandatory, while the official investigator CV template is strongly recommended rather than compulsory. The Netherlands Part II document checklist maps these documents to the CTIS placeholders.

Consent by age and capacity

Capable participants aged 16 or older consent for themselves. For a child under 12, both parents with parental authority, or the guardian, consent. From age 12 through 15, the child also gives written consent. An adult who lacks decision-making capacity requires consent from a legally designated representative, while the participant must still receive information suited to their capacity and any objection must be respected.

Other language versions

This page covers the English Netherlands guide series. A Dutch hub should be linked here when the full Dutch series is published.