Finland CTIS Part II Guides

Start with the right Finland guide

Finland CTIS Part II document checklist

Use this first to identify every standard and conditional Part II document, the accepted language, the submission-time signature position and the relevant template.

Read the Finland CTIS Part II document checklist

Finland patient information and consent requirements

Use the main consent guide to prepare the Finnish or Swedish Participant Information Sheet and Informed Consent Form using Tukija's national template.

Read the Finland patient information and consent requirements

Finland patient-facing document QC checklist

Use this final review before submission to check protocol consistency, population coverage, Finnish language details, privacy, insurance, signatures and version control.

Read the Finland patient-facing document QC checklist

Finland healthy volunteer consent requirements

Use this variation when the trial recruits healthy volunteers and the standard patient-focused wording must be adapted for a non-therapeutic setting.

Read the Finland healthy volunteer consent requirements

Finland minor consent and assent requirements

Use this guide for children and adolescents. It explains Finland's age-15 rule, guardian involvement, age-appropriate information and re-consent.

Read the Finland minor consent and assent requirements

Finland limited-capacity participant and legal representative consent requirements

Use this variation when illness, disability or another comparable reason prevents an adult from understanding enough to consent independently.

Read the Finland limited-capacity participant and legal representative consent requirements

Finland emergency enrollment consent requirements

Use this guide when the protocol relies on the narrow emergency pathway in Article 35 and consent may only be sought after the first intervention.

Read the Finland emergency enrollment consent requirements

Finland impartial witness consent requirements

Use this variation when a participant or legal representative can consent but cannot write and an impartial witness will be used to record consent.

Read the Finland impartial witness consent requirements

Finland pregnancy follow-up consent requirements

Use this guide to distinguish follow-up of a pregnant trial participant from collection of data about a pregnant partner, who requires a separate consent package.

Read the Finland pregnancy follow-up consent requirements

Finland secondary and future-use consent requirements

Use this guide when data or biological samples may be used outside the trial protocol, including optional long-term storage and future research.

Read the Finland secondary and future-use consent requirements

The main Finnish differences

Tukija and Fimea share the national process

Tukija prepares the Part II assessment report and performs the ethical review. Fimea is Finland's national contact point, supervises clinical trials and makes the authorisation decision. All requests for information, responses and the decision are handled in CTIS.

Finland also operates an accelerated procedure for applications concerning Finland only. Since 11 February 2026, national applications of any phase and sponsor type may receive a decision within 30 calendar days from CTIS submission when no assessment-stage corrections or requests for information are needed. This is a processing pathway, not a reduced dossier.

Participant materials are national-language documents

The Finnish Clinical Trials Act allows the general application dossier in Finnish, Swedish or English. It reserves recruitment advertising and Annex I section L materials for Finnish or Swedish. Tukija states that participant information and consent documents must be in Finnish and/or Swedish. A Swedish version does not need to be submitted in CTIS after the Finnish version has been approved.

Participants who do not speak Finnish or Swedish must receive all patient-facing documents in a language they understand. Unless the research team speaks that language, an interpreter familiar with clinical trials, the participant's culture and the Finnish operating environment is needed throughout the research. The Finland patient information and consent guide explains the full document and consent process.

Finland uses national and EU templates together

Tukija requests the EU recruitment and informed-consent procedure template and the standard EU Part II templates for investigator CVs, declarations of interest, site suitability and participant compensation. Tukija also provides a detailed Finland-specific Participant Information Sheet and Informed Consent Form template, updated on 25 June 2026.

The revised EU Recruitment and Informed Consent Procedure template v2.0 was published on 1 June 2026. It is recommended for new Part II submissions now, and its transition period ends on 1 September 2026.

Finland has specific consent and sample rules

Finland defines the legal representative for an adult with reduced capacity and permits a close family member or other close person to consent if there is no formal legal representative. A capable adolescent aged 15 or older may consent independently in a qualifying direct-benefit trial, with the guardian informed.

The biological-sample compliance statement is completed even when the trial collects no samples. If samples or related data will be used outside the protocol for future research, Tukija advises a separate information sheet and consent form that is optional and independent of trial participation. The Finland secondary-use consent guide explains this additional package.

Other language versions

This package contains the English guide series. The reciprocal Finnish hub link should be added when the Finnish pages have been translated, verified and published.