Slovakia CTIS Part II Document Checklist

Required CTIS Part II documents

Recruitment and informed consent procedure

Mandatory. Complete the EudraLex informed consent and patient recruitment procedure template and upload it under Recruitment arrangements. Describe how candidates are identified, approached, informed, given time to decide and consented. Explain any use of treating physicians, databases, referrals, advertisements, remote steps or legal representatives.

Use version 2.0 for new Part II submissions from 1 September 2026. Complete the Member State fields for Slovakia. Prepare the submitted content in Slovak or bilingual Slovak and English. No participant or investigator signature is required on this procedural description at CTIS submission.

Recruitment materials

Conditional. Upload each recruitment advertisement or invitation that will be used in Slovakia under Recruitment arrangements. Submit the final Slovak wording and describe non-text formats clearly. Do not use promotional claims, guaranteed benefit or language that could create undue influence. Recruitment material is not signed at submission.

Participant Information Sheet and Informed Consent Form

Mandatory. Upload the blank Slovak Participant Information Sheet and Informed Consent Form under Subject information and informed consent form. The versions submitted to CTIS are not signed. The participant or legal representative and the person conducting the consent discussion sign and date the approved form later, before any trial-specific procedure.

Prepare distinct documents when the information or signature logic differs, including adult, minor, legal representative, pregnancy follow-up and optional sample-use forms. The Slovakia patient information and consent guide explains the standard adult set.

Other patient-facing materials

Conditional. Submit an additional participant document only when the Clinical Trials Regulation or current Commission Q&A requires it. Endpoint-related patient-facing documents follow the specific Part I and translation route in the Q&A. National guidance expects submitted patient-facing documents in English and Slovak. Blank materials are not signed at submission.

Do not bulk-upload every diary, patient card, questionnaire or device instruction. Keep all materials used in Slovakia translated, controlled and available for inspection even when they are not application-dossier documents.

Principal investigator curriculum vitae

Mandatory. Upload a current curriculum vitae for each principal investigator under Suitability of the investigator. The Commission template or a document containing the same information may be used. It should show education, relevant clinical and research experience, current position and Good Clinical Practice training.

The March 2026 Commission Q&A states that a separate CTIS signature on the curriculum vitae is not an application requirement. Retain the signed and dated source document in the Trial Master File or Investigator Site File under Good Clinical Practice. Use Slovak or a bilingual version for the national file.

Principal investigator declaration of interest

Mandatory. Upload a declaration of interest for each principal investigator under Suitability of the investigator. State any financial or other interest that could affect impartiality. Use the EudraLex template or equivalent content.

No separate signature should be requested as part of the CTIS application under the current Commission Q&A. Keep the signed and dated source declaration in the controlled trial file. Earlier national guidance discussed signature practice, so check the live national instruction if the Ethics Committee republishes a revised form.

List of Slovak sites and principal investigators

Mandatory. Upload a clear list under Suitability of the investigator showing every planned Slovak site, the principal investigator's name and position, and the planned number of participants per site or the total planned for Slovakia. Keep names, addresses and participant numbers consistent with the CTIS structured data and site suitability forms. This list is not signed at submission.

Site suitability form

Mandatory. Upload the Slovakia site suitability form for each trial site under Suitability of the facilities. Describe the facility, staff, equipment, pharmacy arrangements, emergency capability and any outsourced trial procedures needed by the protocol.

Slovak national guidance provides a country form and has accepted the CTIS copy without a signature, provided the sponsor ensures the underlying suitability confirmation is properly documented. Retain the signed source where required by the form and trial file. Verify the current form instructions before submission because the national form was updated in 2025.

Proof of insurance or indemnification

Mandatory. Upload a valid insurance certificate under Proof of insurance cover or indemnification. It must cover trial-related injury in Slovakia for the relevant sponsor, trial and period. Current national guidance removed the need to list every Slovak site on the certificate. Check that the policy scope, territory, dates and identifiers still match the application. The insurer's executed certificate is submitted as evidence. No additional sponsor signature is needed.

Participant compensation and reimbursement

Conditional. Explain payments, expenses, compensation and other financial arrangements under Financial and other arrangements. Use the EudraLex participant compensation template when the information is not already stated clearly in the Participant Information Sheet. Distinguish reimbursement of reasonable expenses from payment for time or inconvenience. The document is normally not signed at submission.

Slovak ethics review has identified missing information about travel-cost reimbursement in participant documents. State what will and will not be reimbursed, how claims work and whether payment changes after withdrawal.

Data-protection compliance

Mandatory in the CTIS Form section. Complete the EudraLex statement of compliance with Regulation (EU) 2016/679. The Member State overview reports no separate Slovakia Part II data-protection document beyond that statement. The Slovak Participant Information Sheet must still explain controllers, purposes, legal basis, recipients, transfers, retention, rights, withdrawal and complaint routes in understandable language.

The statement is submitted through the CTIS Form section rather than as a duplicate Part II narrative. Electronic submission by the sponsor is equivalent to signing the application. The Slovakia patient-facing QC checklist covers the privacy checks.

Biological samples

Conditional. If the trial collects, stores, transfers or uses human biological samples, complete the EudraLex template under Compliance with applicable rules for biological samples. Describe the main-trial use, storage period, location, coding, transfers, destruction and any optional future use. The document is not signed at submission unless the current template expressly requires an attestation.

Participant choices about optional future research should be separate from agreement to the main trial. The Slovakia secondary use guide explains how to structure the optional consent.

Conditional national approvals and evidence

Conditional. Slovak Act No. 362/2011 requires additional authorization for trials involving genetically modified organisms and for planned exposure involving investigational radioactive medicinal products or precursors. A site handling removal or transplantation of human organs, tissues or cells must hold the applicable transplant-center authorization. Prepare the official authorization before the activity starts and include it in the application route required for that trial.

Prohibited population. Slovak law prohibits enrollment of people in custody, serving a prison sentence or held in detention. Do not create a consent pathway for this population in a Slovakia medicinal-product trial.

Submission assembly checks

Before submitting, confirm that:

• each Slovak site appears in CTIS, the investigator list and its own site suitability form
• protocol number, EU trial number, sponsor and document version are consistent
• Slovak participant documents are complete and understandable
• English and Slovak patient-facing versions convey the same meaning where both are submitted
• the blank consent forms contain no participant signatures
• controlled signed source documents are retained in the appropriate trial file
• insurance is valid for Slovakia and the expected conduct period
• travel reimbursement and participant contacts are stated
• optional sample or data use is separated from main-trial consent
• only dossier documents permitted by the Clinical Trials Regulation and current Q&A are uploaded

For population-specific document coverage, use the Slovakia minor consent guide, limited-capacity consent guide and pregnancy follow-up guide.

Return to the Slovakia CTIS guide hub for the full country series.