Finland Patient-Facing Document QC Checklist

Trial content checks

Confirm that each document:

identifies a clinical trial on medicinal products, not only a study
includes the correct trial title, code and EU trial number
identifies the sponsor, Finnish site, principal investigator and controller correctly
describes the primary and principal secondary objectives in neutral lay language
explains the investigational medicinal product, comparator, placebo, randomisation and blinding accurately
gives the correct participant duration, visit count, remote contacts and follow-up period
separates standard care from trial-specific procedures and costs
states the planned global and Finnish participant numbers consistently
includes the current site and research-team contact details

Protocol-to-document consistency checks

Compare the participant documents against the protocol and supporting materials for:

dose route and treatment duration
invasive procedures, blood volumes, biopsies and radiation exposure
contraception methods and duration
pregnancy testing, reporting and follow-up
prohibited medicines, washout and rescue treatment
questionnaires, diaries, devices and home procedures
genetic testing, sample types, storage and destruction
severe and common risks for every investigational and comparator product
stopping rules, post-trial treatment and unblinding

Do not resolve inconsistencies by adding every protocol detail. Correct the facts, then keep the participant explanation concise.

Consent logic checks

Confirm that the information and signature pathway matches the participant's legal position. The participant or legal representative must receive the information before signing, have enough time to consider it, ask questions and demonstrate understanding.

Check that:

the person giving consent is correctly identified
the qualified person conducting the prior interview is identified
the participant or legal representative and consent recipient sign and date at consent
no signature or date is required on the blank CTIS submission copy
no exculpatory wording waives legal rights or releases the sponsor or site from liability
withdrawal is possible without reason or detriment
the document distinguishes stopping trial treatment, leaving trial procedures and withdrawing optional future-use consent
the original signed record is archived and a copy is given to the participant or representative
the procedure explains electronic or remote elements when used

Finland does not apply the simplified consent pathway for cluster trials in Article 30. Do not replace individual informed consent with non-objection for a Finnish cluster trial.

Population and document coverage

Create a document matrix by participant group. Confirm that the trial has the applicable information and consent documents for:

For each population, confirm that the information is understandable for that person's age and capacity. Tukija expects separate documents for representatives and for distinct groups recruited because of age or cognitive ability.

Data privacy checks

Verify that the Participant Information Sheet or attached privacy notice provides the GDPR Articles 12 to 14 information. Check the controller, contact details, purpose, legal basis, data categories, sources, recipients, storage period, rights, complaint route and international transfers.

Confirm that:

each legal basis is cited by article, paragraph and point
any legitimate-interest basis includes a brief balancing-test explanation
pseudonymised data are not described as anonymous
access to health records, registries and remote source-data verification is disclosed
known non-EU or non-EEA transfer countries and safeguards are stated
the Data Protection Ombudsman route is correct
language for privacy questions matches the consent process
the Finnish participant text uses the equivalent of ethnic background rather than race

Biosample and secondary-use checks

For samples used within the protocol, check the type, quantity, purpose, storage, location, analysis, transfer, genetic testing, return of findings and destruction. Confirm that the CTIS biological-sample compliance statement agrees with these facts.

For use outside the protocol, confirm that:

a separate optional information sheet and consent form are used
refusal has no effect on trial participation or treatment
the future sponsor or controller, purpose, retention and storage location are described
additional sample collection is distinguished from leftover-sample use
sharing, transfers and possible genetic analysis are explained
participants can withdraw future-use consent
the limits of withdrawal for studies already begun are explained

Finland-specific regulatory checks

Confirm the following national points:

recruitment advertisements, consent procedures, information sheets and consent forms are in Finnish and/or Swedish
all materials are available in a language each participant understands
an appropriate interpreter is available throughout the trial when the team does not speak that language
the revised EU Recruitment and Informed Consent Procedure template v2.0 is used for a new submission
Tukija's Participant Information Sheet and Consent Form template dated 25 June 2026 is the drafting baseline
participant information includes the Finnish insurance and patient-insurance pathway, adapted only where actual cover differs
the trial code and a concise Finnish trial title identify the Finnish document
Article 30 simplified cluster consent is not used
the sample-compliance form is completed even when no samples are collected
other participant forms are placed according to Tukija's Finland-specific Part I instruction

Signature, version and administrative checks

Verify that every file has a clear document type, population, language, version and date. Match these identifiers in the footer, filename, change log and CTIS metadata.

Confirm that:

blank submission documents contain signature fields but no completed signatures
all translated versions correspond to the same approved source version
tracked changes, comments, instructions and template prompts are removed
optional consent choices are not preselected
the participant and consent-recipient signature fields are distinct
witness and representative fields appear only in documents that use those pathways
superseded site details and phone numbers have been removed
public and not-for-publication versions follow current CTIS transparency rules

Readability and document-design checks

Aim for 5 to 8 pages and normally no more than 10 for the main information sheet. A longer document needs a real complexity justification. Use headings, short paragraphs, lists only where useful and enough white space.

Remove commands, promotional language, unexplained abbreviations, excessive legal text and detailed operating instructions that belong in a separate participant guide. Check that formality and direct address are consistent in Finnish or Swedish. Ask lay readers and site staff to test the final draft.

The main Finland patient information and consent guide provides the content baseline. Return to the Finland CTIS hub for every specialised variation.