Czechia CTIS Part II Document Checklist

Required Czechia CTIS Part II documents

Document list

Mandatory. Submit a machine-readable list of the documentation under review, including each document version and date. SÚKL allows this list to sit inside the cover letter, so a separate list-of-documents file is not required. SÚKL does not specify a national signature requirement for this list.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit the Czech PIS/ICF in Part II under the SÚKL category All Documents. Do not submit the original English version for routine Czech review. Standard bilingual PIS/ICF versions are not permitted.

The PIS/ICF submitted in CTIS is the blank approved form, so the participant does not sign it at application submission. During trial conduct, informed consent is documented in accordance with the Clinical Trials Regulation. The participant or legally designated representative, as applicable, and the person conducting the consent interview sign and date the consent record. SÚKL permits specified electronic signature methods for electronic PIS/ICF.

The Czech form must contain the national items specified by SÚKL, including the EU CT Number, the full trial title, the ethics committee contact email, source-record access language, the statement about publication of results on the EMA clinical trials website and confirmation that the participant receives a dated and signed copy. The main Czechia PIS/ICF guide covers these items in detail.

Age-specific and capacity-specific consent documents

Conditional. Add separate or adapted participant-facing documents when the study includes minors, adults with limited capacity, emergency enrollment or a consent pathway requiring an impartial witness. These documents are not signed by future participants at CTIS submission. They are submitted as blank forms and signed during the applicable consent procedure.

SÚKL requires written information for minors aged 12 to 14 and 15 to 17. The minor consent and assent guide maps the Czech age bands. For other situations use the limited-capacity guide, emergency enrollment guide or impartial witness guide.

Other participant materials

Conditional. Submit participant materials that apply to the trial, such as diaries, participation cards and questionnaires. SÚKL says these should be in Czech. A questionnaire may be submitted in English only when it will be completed together with the participant by the investigator, in which case SÚKL says it will not be listed among the approved documents in the Decision.

For electronic questionnaires, submit screenshots. Instructions for use are mandatory when applicable for medicinal products self-administered by participants and for relevant medical devices. Use the patient-facing document QC checklist before upload.

Recruitment and informed consent procedure

Mandatory. Submit SÚKL Template No. 1, Trial subject recruitment and obtaining of informed consent, under Recruitment Arrangements. The national template is bilingual and may be completed in Czech or English.

Submit all recruitment advertisements, leaflets and other materials. Where recruitment uses audio, video or another non-print format, SÚKL asks sponsors to submit that format in CTIS if possible. The current national Template No. 1 does not contain a participant or investigator signature block for application submission.

Timing note for September 2026. The European Commission has published version 2.0 of the harmonised recruitment and informed consent procedure template and states that full implementation begins on 1 September 2026. As of this review date, SÚKL's January 2026 national guideline still requires its attached Template No. 1. For a Czech submission on or after 1 September 2026, re-check the current SÚKL page and EudraLex before final upload.

Investigator Curriculum Vitae

Mandatory. Submit the current principal investigator CV using SÚKL Template No. 2 under Suitability of the Investigator. Complete it in Czech. It must be dated and signed by the physician at application submission.

If GCP training is documented only in the CV, include the month, year and training provider. If a separate Good Clinical Practice certificate is submitted, SÚKL states that it must not be older than three years and must identify the version of ICH E6 covered by the training.

For the CV, SÚKL accepts a handwritten signature or a recognized, qualified or guaranteed electronic signature, or a dynamic biometric signature. SÚKL expressly states that DocuSign or a sponsor-created signature that does not meet its criteria is not accepted.

Declaration of investigator interest

Mandatory. Submit SÚKL Template No. 3, Declaration of Investigator's Interest, in Czech under Suitability of the Investigator. It must be dated and signed by the physician at submission. The same national signature rules described for the investigator CV apply.

List of trial sites and principal investigators

Mandatory. Submit a machine-readable list in Czech with trial sites and principal investigators. Preserve Czech diacritics and all academic titles. SÚKL does not ask for lists of sub-investigators or other study-team members in Part II. Their records and GCP evidence should remain available at the site.

Site suitability

Mandatory. Submit SÚKL Template No. 4 under Suitability of the Facilities for each Czech trial site. The form must identify the site name and address and should be signed at submission by the department head, clinic director or principal investigator.

The same permitted handwritten or electronic signature methods apply. SÚKL states that DocuSign or a sponsor-created signature that fails the national criteria is not acceptable.

Healthcare-facility evidence

Conditional. For non-state healthcare facilities, and for facilities established by entities other than the Czech Ministry of Health, submit evidence from the Regional Authority confirming healthcare-facility status and permitted scope of activities. The same evidence is required for a sub-site when part of the trial is performed there.

Where protocol procedures are performed outside the main site, identify who provides them in the site documentation. For bioequivalence, pharmacokinetic and First-in-Human sites that are required to hold a SÚKL GCP certificate, submit a scan of that certificate.

Insurance

Mandatory. Submit the insurance certificate and the complete insurance policy including the terms and conditions under Proof of Insurance Cover or Indemnification. The complete insurance documentation must be in Czech or in a bilingual version. SÚKL explicitly states that submission of the insurance terms and conditions is mandatory.

The certificate does not need to state the number of enrolled participants. If it does state that number and the planned number later increases, submit an updated certificate as a non-substantial modification.

Also submit a sponsor statement explaining how compensation will be ensured for health damage caused by trial participation that becomes apparent only after the trial and after the insurance policy expires.

Sponsor declaration on personal data processing

Mandatory. Submit the sponsor-signed SÚKL Template No. 5 under Compliance with National Requirements on Data Protection. A third-country sponsor must sign the declaration itself. An EU representative or CRO may not sign it instead.

SÚKL permits the sponsor to use the same declaration submitted in Part I under Forms, but it must also be submitted in the Part II data-protection category.

Biological-sample compliance form

Conditional. When human biological samples are collected or stored, prepare SÚKL Template No. 7 under Compliance with Use of Biological Samples and complete it in full. The form covers samples collected during the trial as well as future use.

If participants are asked to allow storage and future research use of trial samples, that choice may appear in the main PIS/ICF only with a separate signature, or it may be a separate signed document. The consent text should state storage duration, whether samples remain pseudonymized or become fully anonymized and the main purpose of future research. The secondary-use consent guide explains the consent structure.

Compensation and reimbursement information

Mandatory information. Submit the Czech participant compensation and reimbursement information under Financial and Other Arrangements. SÚKL provides Template No. 6. If the sponsor does not use the template itself, it must provide references showing where every item from the template is addressed.

The description must cover expense reimbursement, compensation, any remuneration and the payment method. SÚKL recommends standardising compensation payments as a lump sum. If payment cards are used, national conditions apply, including no participant fees, Czech-language support and an alternative reimbursement method.

Financial coverage

Mandatory. Submit a description of how the clinical trial will be funded under Financial and Other Arrangements. SÚKL's current guideline requires the description but does not prescribe a separate national signature form for it.

Proof of Part II fee payment

Mandatory later in validation, not at initial submission. Do not pay the Czech Part II fee before the designated Ethics Committee is known. SÚKL identifies the committee in the validation request and provides the applicable payment pathway. Evidence of payment is then provided within the assessment process.

If the SÚKL Ethics Committee is assigned, follow UST-29 and the applicable K-023 to K-028 code. If a multicentre Ethics Committee is assigned, provide billing information and use the payment instructions for that committee.

Medical-device documents

Conditional. When a medical device or in vitro diagnostic device is used within the clinical trial of a medicinal product, SÚKL requires the applicable conformity documents and Czech instructions for use and asks the sponsor to identify device use in the application. Non-CE-marked devices and devices used outside their intended purpose trigger additional national declarations and, where required, a separate clinical investigation or performance-study authorisation pathway. Check the current KLH-CTIS-01 text for the exact device scenario.

Czechia submission resources

The central operational source is SÚKL KLH-CTIS-01 Version 3. Its annexes contain the national Part II templates. Use the current SÚKL page rather than an older saved form because the templates were reissued in January 2026.

For the core participant-facing package, use the Czechia PIS/ICF guide and the patient-facing QC checklist. The full guide directory is on the Czechia CTIS hub.