Finland CTIS Part II Document Checklist

Recruitment and participant documents

Recruitment arrangements

Mandatory content. Describe the inclusion procedure and clearly identify the first act of recruitment. A separate document is required under Annex I section K when the information is not already in the protocol. Tukija requests use of the EU Recruitment and Informed Consent Procedure template. Complete the Finland-specific parts in Finnish and/or Swedish. Submit it under Recruitment arrangements. It is not signed at submission.

Use template v2.0 for new submissions. The transition period for the revised template ends on 1 September 2026.

Recruitment advertisements and invitations

Conditional. Submit every advertisement, invitation and communication used to recruit participants, plus the procedure for handling responses and informing people found unsuitable. Materials must be in Finnish and/or Swedish and are not signed at submission. Do not upload audio or video files. Submit a transcript for audio, and a transcript or storyboard for video. Upload these under Recruitment materials.

Participant Information Sheet and Informed Consent Form

Mandatory. Submit the blank documents that potential participants or their legal representatives will receive before deciding. Use Tukija's Finland-specific template and adapt it to the protocol and population. The Participant Information Sheet and Informed Consent Form must be in Finnish and/or Swedish. They are not signed at submission. The participant or legal representative and the person receiving consent sign and date the approved documents when consent is obtained.

A Swedish version does not need to be added to CTIS after the Finnish version has been approved. Participants who do not speak Finnish or Swedish still need documents in a language they understand and, unless the study team speaks that language, continuing interpreter support. The Finland patient information and consent guide explains the content and signature process.

Recruitment and informed-consent procedure

Mandatory. Describe how information is provided, who conducts the prior interview, how understanding is confirmed, how much decision time is allowed and how consent is documented. Include every relevant pathway for minors, adults with reduced capacity, impartial witnesses and emergency enrollment. Complete the EU template in Finnish and/or Swedish. It is not signed at submission and belongs under Subject information and informed consent procedure.

Population-specific information and consent documents

Conditional. Submit separate, understandable documents for each population that follows a different information or signature pathway. This can include children by developmental band, adolescents, guardians, adults with reduced capacity, legal representatives, emergency participants and pregnant partners. These documents must be in Finnish and/or Swedish and are blank at submission.

Select the applicable variation before finalising the set: healthy volunteers, minors, limited-capacity adults, emergency enrollment, impartial witnesses and pregnancy follow-up.

GDPR information for participants

Mandatory. Include all information required by Articles 12 to 14 of the General Data Protection Regulation. It may sit in the Participant Information Sheet, a separate privacy notice or an annex. It follows the same Finnish and/or Swedish language rule as the consent set. It is not signed at submission.

Investigator and site documents

Planned sites and principal investigators

Mandatory. Provide the planned Finnish sites, each principal investigator's name and position, and the planned participant number at each site. Enter the structured site information in CTIS and provide any required supporting document. English is accepted unless participant-facing content is included. No signature is required at submission.

Investigator curriculum vitae

Mandatory. Provide a current CV describing professional and scientific qualifications, relevant patient-care and clinical-trial experience, and Good Clinical Practice training. Tukija requests the EU Investigator Curriculum Vitae template. English is accepted and no signature is required at submission. Upload it under Suitability of the investigator.

Declaration of interest

Mandatory. Disclose economic interests, institutional affiliations and other conditions that could influence investigator impartiality. Tukija requests the EU Declaration of Interest template. English is accepted and no signature is required at submission. Upload it under Suitability of the investigator.

Site suitability statement

Mandatory. Explain why each site has suitable facilities, equipment, staff and expertise for the protocol and investigational medicinal product. Tukija requests the EU Site Suitability template. Finland permits one document for all sites if the sites are clearly separated. A sponsor contact person or another sponsor representative may make the statement. English is accepted and no signature is required at submission. Upload it under Suitability of the facilities.

Insurance, finance and fees

Insurance or other guarantee

Mandatory. The sponsor must ensure insurance or another appropriate guarantee covering sponsor and investigator liability for participant injury. Submit a separate description of the arrangement under Proof of insurance cover or indemnification. English is accepted and no signature is required at submission.

The participant information must also describe the actual compensation system. Tukija's standard wording distinguishes Pharmaceutical Injuries Insurance from the trial site's patient insurance. Amend it if the investigational medicine is not covered by Pharmaceutical Injuries Insurance.

Trial financing and site payments

Mandatory. Explain the sponsor, conflicts or commitments linked to the sponsor, total site costs and their basis, investigator fees in euros, other trial-personnel remuneration in euros and recruitment resources. English is accepted and no signature is required at submission. Upload it under Financial and other arrangements.

Compensation and costs for participants

Mandatory statement, with conditional payment details. Use the EU Compensation for Trial Participants template to state expenses, loss of earnings, inconvenience payments and any costs that could fall to the participant. Protocol-required medicines, administration devices and procedures are normally free. Explain and justify any exception. English is accepted for the administrative form. Participant-facing explanations must be in the participant document language.

Other sponsor-site agreements

Conditional. Describe any other relevant agreement between the sponsor and site. Finland does not require the actual sponsor-site or site-investigator agreement in the initial application, though Tukija may request a supplement. English is accepted and no signature is required at submission.

Finland invoicing details

Mandatory administrative information. Finland charges one joint fee through Fimea. Fimea invoices the sponsor after Part I has been accepted for processing. In the CTIS Proof of payment section, provide invoicing details matching Fimea's customer-data reporting form and include any purchase-order or project number that must appear on the invoice. This is invoicing information, not evidence of a pre-submission payment.

Data and biological samples

Sponsor statement on EU data-protection compliance

Mandatory. Complete the EU statement confirming that data will be collected and processed in accordance with Union data-protection law. Use the Form section in CTIS. English is accepted and no separate signature is required because submission through CTIS is treated as the sponsor's confirmation.

Biological-sample compliance statement

Mandatory for every application. Use the EU Compliance with Member State Applicable Rules for the Collection, Storage and Future Use of Human Biological Samples template. Complete it even when the trial collects no samples. If none are collected or used, select No and mark the detailed sections not applicable as instructed. English is accepted and no signature is required at submission.

If the trial requests optional future use of samples or related data outside the protocol, submit a separate future-use Participant Information Sheet and Informed Consent Form using Tukija's template. The Finland secondary-use consent guide explains the additional documents.

Other patient-facing forms

Conditional. Questionnaires, diaries and other forms intended for participants must be understandable and consistent with the protocol. Finland applies a specific placement rule. Tukija does not require separate translations in Part II for patient-facing documents other than recruitment materials and participant information sheets. It asks for those forms in Part I in Finnish, Swedish or English, generally following the protocol language. Check the current CTIS upload structure before filing, because the European Commission Q&A generally places participant-form translations in Part II.

Submission-format check

Before submitting, confirm that:

• documents are PDF or PDF/A
• no dossier document has been signed merely for submission
• Finnish and/or Swedish versions are used for recruitment and consent materials
• all conditional populations and procedures have their own documents
• version numbers and dates agree across the protocol, PIS, ICF and recruitment materials
• personal data intended for publication have been removed or protected according to current CTIS transparency rules

Run the full set through the Finland patient-facing document QC checklist and return to the Finland CTIS guide hub for the detailed population guides.