Sweden CTIS Part II Guide

How Sweden differs from a generic EU Part II package

Sweden has national implementation details that directly change the dossier.

Swedish is the working language for Part II. Do not rely on an English multinational Part II set for Sweden. Recruitment material, participant information, consent documents and the other Annex I points 59 to 73 need Swedish content. A separate biological-sample document is also expected in Swedish when used.

Sweden uses national forms and templates. Läkemedelsverket lists Swedish templates for the recruitment and consent procedure, investigator CV, declaration of interests, site suitability, participant compensation and compliance with rules for biological samples. The European Commission also publishes harmonised Part II templates in EudraLex Volume 10.

Consent has a national professional-role rule. The normal Swedish rule is that a licensed physician or licensed dentist conducts the Article 29 interview and obtains informed consent. Läkemedelsverket can permit another healthcare professional where special reasons exist and the sponsor justifies the arrangement.

Minors aged 15 or older may need their own consent. Swedish law, as amended in 2026, requires a minor who has turned 15 to also provide informed consent when the minor understands what participation means. Guardian consent still applies.

Biobanks can create a parallel national process. If human biological samples are covered by the Biobank Act, Sweden strongly encourages early contact with the relevant Regional Biobank Centre and a parallel biobank application where applicable.

Sweden CTIS Part II guide directory

Sweden CTIS Part II Document Checklist

Use this first to identify the Swedish Part II documents, language rules, CTIS categories and national templates.

Open the Sweden CTIS Part II Document Checklist guide

Sweden Patient Information and Consent Requirements

Use this for the main Swedish participant information sheet and informed consent form.

Open the Sweden Patient Information and Consent Requirements guide

Sweden Patient-Facing Document QC Checklist

Use this before submission to check Swedish participant documents against the protocol and national rules.

Open the Sweden Patient-Facing Document QC Checklist guide

Sweden Healthy Volunteer Consent Requirements

Use this when healthy volunteers need a participant information and consent version adapted to their risk and benefit context.

Open the Sweden Healthy Volunteer Consent Requirements guide

Sweden Minor Consent and Assent Requirements

Use this for children, adolescents and guardian consent, including Sweden's age 15 rule.

Open the Sweden Minor Consent and Assent Requirements guide

Sweden Limited-Capacity and Legal Representative Consent Requirements

Use this when an adult cannot provide valid informed consent and a Swedish legally designated representative may be needed.

Open the Sweden Limited-Capacity and Legal Representative Consent Requirements guide

Sweden Emergency Enrollment Consent Requirements

Use this when Article 35 emergency enrollment before prior consent is part of the protocol.

Open the Sweden Emergency Enrollment Consent Requirements guide

Sweden Impartial Witness Consent Requirements

Use this when a participant cannot write or sign and an independent witness procedure is proposed.

Open the Sweden Impartial Witness Consent Requirements guide

Sweden Pregnancy Follow-Up Consent Requirements

Use this for pregnancy-related participant information and study-specific follow-up of a pregnant participant or partner.

Open the Sweden Pregnancy Follow-Up Consent Requirements guide

Sweden Secondary Use Consent Requirements

Use this for optional future use of trial data or biological samples and Swedish biobank implications.

Open the Sweden Secondary Use Consent Requirements guide

A practical order for preparing the Swedish dossier

Start with the Sweden CTIS Part II document checklist to map the submission set. Draft the main Sweden patient information and consent documents next because recruitment, compensation, insurance, data use and sample handling need to stay consistent across the dossier.

Then add only the population-specific variants that the protocol requires. The most consequential Swedish variation is the minor consent and assent pathway, particularly for participants who are 15 to 17 years old. Trials involving samples should also review the secondary use consent guide early enough to coordinate with the biobank process.

Before uploading, use the Sweden patient-facing document QC checklist to check language, population coverage, consent logic, protocol consistency and version control.