Sweden CTIS Part II Document Checklist

Required CTIS Part II documents

Recruitment arrangements

Mandatory. unless the required information is already in the protocol. Describe how potential participants are identified and what constitutes the first act of recruitment in Sweden. Recruitment material such as advertisements is Conditional and must be attached when it will be used.

Language: Swedish.

Signed at CTIS submission: No signature requirement is stated for the recruitment description or advertisement.

CTIS location: K1 Recruitment arrangements and K2 Recruitment material description.

Template: Läkemedelsverket lists the Swedish recruitment and consent procedure template. EudraLex Volume 10 also provides the harmonised Recruitment and Informed Consent Procedure template v2.0. As of this review, the v2.0 transition period runs until 1 September 2026, so use the current version for new submissions and include Sweden-specific information.

For the consent portion, use the Sweden patient information and consent requirements guide.

Participant Information Sheet and Informed Consent Form

Mandatory. Submit the Swedish participant information and the blank consent form for each population that will be recruited. Add separate age-specific or situation-specific documents when the consent process differs.

Language: Swedish.

Signed at CTIS submission: No. The submitted forms are the proposed blank documents. Signatures and dates are added when consent is actually obtained before trial-specific procedures, except where the CTR permits emergency enrollment before prior consent.

CTIS location: L1 SIS and ICF description. Other participant-facing material belongs under L2 when applicable.

Template: Sweden does not impose one universal national participant information form in the official sources reviewed. The Swedish Ethical Review Authority points sponsors to a participant information support template from Clinical Studies Sweden. The legal requirements remain those in the CTR and Swedish rules.

Use the main Swedish consent guide and the relevant population guide before finalising the set.

Other participant-facing information

Conditional. Submit diaries, information leaflets, cards, instructions or other materials when they provide information to participants or legal representatives and form part of the participant-facing trial process.

Language: Swedish when directed to Swedish participants.

Signed at CTIS submission: Normally no. If a document contains a consent or acknowledgement section, the blank form is submitted and the actual signatures are obtained during trial conduct.

CTIS location: L2 Other subject information material.

The patient-facing document QC checklist helps determine whether the full participant-facing set is covered.

Investigator suitability

Mandatory. Provide current information showing that each responsible investigator is qualified by education, Good Clinical Practice training, clinical trial experience and patient-care experience appropriate to the trial.

Language: Swedish under the Swedish language rule for Annex I points 59 to 73.

Signed at CTIS submission: The CTR and Swedish guidance reviewed do not state a general wet-ink signature requirement for the uploaded CV. Follow the fields and execution instructions in the current template.

CTIS location: M1 CV Investigator.

Template: Läkemedelsverket lists the Swedish `Prövarens CV` template.

Declaration of interests

Mandatory. Disclose financial interests and institutional affiliations that could affect impartiality for the investigator.

Language: Swedish.

Signed at CTIS submission: Follow the current Swedish declaration template. The official application guidance does not create a separate universal wet-ink rule beyond the template's current execution requirements.

CTIS location: M2 Declaration of interest.

Template: `Deklaration av intressekonflikter`.

Site suitability

Mandatory. for each Swedish trial site. Provide a written justification covering facilities, equipment, staffing and expertise. Swedish guidance says the statement should be obtained from the head of the clinic or institution, or another responsible person according to the applicable arrangement.

Language: Swedish.

Signed at CTIS submission: The statement must be issued by the appropriate site or institution representative. Use the current template's signature or approval fields rather than adding a separate signature convention.

CTIS location: N1 Site suitability form.

Template: `Prövningsställets lämplighet`.

Insurance or indemnification

Mandatory. in substance. Swedish law requires the sponsor to ensure, through insurance or another arrangement, that a participant can receive compensation where the sponsor or investigator becomes liable. The protection must match the nature and extent of the risk. Swedish application guidance asks for documentation of the applicable participant protection and any sponsor-specific clinical trial insurance.

Language: The description of the Swedish insurance arrangement should be in Swedish. An insurer-issued certificate in English may be attached where accepted by the authority guidance.

Signed at CTIS submission: No separate participant or investigator signature is required. Use the issued insurer or coverage documentation.

CTIS location: O1 Trial participant insurance certificate and O2 proof of other coverage where relevant.

The participant information should explain the right to compensation for injury consistently with these documents. See the Sweden consent guide.

Financial and other arrangements

Mandatory. Describe trial financing and payments or compensation to participants, investigators and sites. Explain other relevant sponsor-site financial arrangements.

Language: Swedish.

Signed at CTIS submission: A separate signature is not stated as a general requirement for the Part II financial description. Use current national forms as intended.

CTIS location: P1 Compensation, investigator, funding and other arrangements.

Template: `Ersättning för deltagande i klinisk prövning` is listed by Läkemedelsverket for participant compensation.

Proof of fee or Swedish invoicing information

Conditional. according to the national fee process. Follow the current Läkemedelsverket instructions for the fee-related document and invoicing information placed in CTIS.

Language: Because Annex I point 72 falls within Sweden's Swedish-language range, prepare the national fee information in Swedish unless the authority form itself specifies otherwise.

Signed at CTIS submission: No participant or investigator signature applies. Follow the current authority form.

CTIS location: Q Proof of payment of fee or the corresponding CTIS area instructed by Läkemedelsverket.

Data protection compliance statement

Mandatory. The Part II dossier must contain the statement on compliance with national requirements for the collection and use of personal data.

Language: The Annex I point 73 Part II content is subject to Sweden's Swedish-language rule. Läkemedelsverket also references the EU GDPR compliance template for the CTIS Form section. Do not treat an English Form-section statement as a substitute for a Swedish Part II item where the Swedish language rule applies.

Signed at CTIS submission: No participant signature applies to this compliance statement.

CTIS location: R1 Compliance on the collection and use of personal data.

Biological-sample compliance

Conditional. Include this when biological samples are collected, stored or used in a way that requires the CTIS biological-sample compliance document.

Language: Swedish when submitted as a separate Sweden document.

Signed at CTIS submission: The CTIS compliance document itself has no participant signature. Participant consent to sample use is handled in the participant information and consent documents when applicable.

CTIS location: S1 Compliance on the collection, use and storage of biological samples.

Template: Läkemedelsverket lists `Följsamhet med regler för hantering av biologiska prov`.

If the Swedish Biobank Act applies, the CTIS document is not the whole national process. A parallel biobank application may also be needed and should be prepared early. The Sweden secondary use consent guide explains the consent implications.

Sweden-specific language check

The Part II language rule is broader than the participant information alone. Swedish law requires Annex I points 59 to 73 to be in Swedish. It also requires the protocol synopsis under point 24 to be Swedish, even though that synopsis belongs to Part I. Läkemedelsverket expects participant-directed questionnaires and other subject-directed material to be Swedish.

For a multinational trial, maintain the master content centrally but create a controlled Swedish country version for every affected document. Do not submit both Swedish and English versions of the same document simply because both exist internally when only one version is requested.

Country submission resources

The key national resources are Läkemedelsverket's CTIS application guidance, Etikprövningsmyndigheten's CTR page and, for studies involving samples, Biobank Sweden's CTR pathway. The European Commission's EudraLex Volume 10 contains the current EU templates and CTR Q&A.

Return to the Sweden CTIS Part II hub for the full guide set.