Czechia CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

Before checking wording, verify that the participant documents describe the same trial the protocol describes.

• Confirm the full clinical trial title and EU CT Number are correct in every PIS/ICF version.
• Confirm sponsor identity and the study purpose.
• Match treatment arms, randomisation, placebo or comparator information and assignment probabilities to the protocol.
• Match visit schedules, procedures, sample collection, imaging, questionnaires and participant responsibilities.
• Match treatment duration, follow-up period and any long-term follow-up.
• Match the investigational medicinal product route, frequency and relevant handling instructions.
• Confirm that participant-facing device instructions are included when self-use or device use requires them.
• Remove procedures or claims carried over from an older protocol version.

Protocol-to-participant consistency checks

The PIS/ICF should translate the protocol rather than reproduce it mechanically.

• Confirm foreseeable treatment and procedure risks are represented in understandable language.
• Confirm pregnancy, contraception and breastfeeding restrictions match the protocol.
• Confirm prohibited concomitant treatment or lifestyle restrictions that materially affect participants are explained.
• Confirm expected benefits are stated cautiously and no benefit is promised.
• Confirm alternatives to participation are described where relevant.
• Confirm withdrawal procedures and post-withdrawal follow-up match the protocol.
• Confirm injury, insurance and reimbursement statements agree with the Part II insurance and financial-arrangements documents.

Consent logic checks

The form should make every required decision clear.

• Confirm the main trial participation decision is distinct from optional activities.
• Confirm optional future research, optional substudies or optional sample retention can be refused without making the main trial consent internally contradictory.
• Confirm each optional future-sample choice has the separate signature required by SÚKL or is moved into a separate signed document.
• Confirm the participant or legally designated representative signs only at the time of consent, not in the blank CTIS submission file.
• Confirm the person conducting the consent interview signs and dates the executed consent record under the applicable CTR process.
• Confirm the form states that one dated and signed copy is provided to the participant and one remains at the site.
• Confirm re-consent triggers are defined when a child reaches a new age band, reaches adulthood, or an adult participant's capacity changes.

Population and document coverage checks

Do not rely on one adult PIS/ICF when the trial population needs different information or consent-givers.

Minors. SÚKL requires written information for ages 12 to 14 and 15 to 17. Younger children may sign with their parents to express willingness, but SÚKL states that a signature under age 11 is not mandatory. Use the minor consent and assent guide.

Limited capacity. Check whether the adult can give valid healthcare consent under the applicable legal status and whether a legally designated representative must consent. Adapt information to the participant's ability and preserve the participant's involvement and right to object. Use the limited-capacity guide.

Emergency enrollment. If the protocol relies on Article 35, check that the Part II package describes the emergency inclusion conditions, documentation of urgency and the process for obtaining consent to continue without undue delay. Use the emergency enrollment guide.

Impartial witness. If a participant cannot write or cannot read, check that the witness procedure, witness independence and signature statement are described. Use the impartial witness guide.

Healthy volunteers. Confirm that the document accurately explains the absence of therapeutic intent, the study procedures and compensation structure. Use the healthy volunteer guide.

Pregnancy follow-up. Separate follow-up of a pregnant participant from collection of information about a pregnant partner. Use the pregnancy follow-up guide.

Data privacy checks

• Confirm participant-facing privacy information matches the actual data flow, recipients and transfers.
• Confirm the PIS/ICF contains SÚKL's required access-to-source-record wording covering monitors, auditors, regulators or medicines agencies, Ethics Committee members and study-team members as applicable.
• Confirm sponsor and controller descriptions are consistent across the PIS/ICF and Part II data-protection documents.
• Confirm data withdrawal language does not promise deletion that the trial's legal and scientific record cannot support.
• Confirm the separate sponsor-signed SÚKL Template No. 5 is included in the Part II data-protection category.
• For a third-country sponsor, confirm the sponsor itself signs Template No. 5 rather than an EU representative or CRO.

Biological-sample and secondary-use checks

• Confirm protocol-required samples are described with purpose, collection and handling at the right level for participants.
• Confirm optional future research is clearly optional.
• Confirm future-use wording states storage duration, pseudonymised or anonymised status and the main intended research purpose.
• Confirm future-use consent has a separate signature if embedded in the main PIS/ICF, or use a separate signed document.
• Confirm SÚKL Template No. 7 is completed for the biological-sample pathway and covers samples collected during the trial as well as future use.
• Confirm withdrawal wording distinguishes identifiable or pseudonymised stored samples from material that has already been fully anonymised or used in completed research.

The secondary-use consent guide covers this structure.

Czech national content checks

Mandatory. Confirm every PIS/ICF version contains:

• the EU CT Number
• the full clinical trial title
• the required ethics committee email
• no ethics committee telephone number
• the statement that results will be available on the EMA clinical trials website
• consent for the specified access to source medical records
• wording that the participant receives a dated and signed copy and one copy remains at the site

Also confirm the standard Czech submission does not include the English original or a bilingual PIS/ICF.

Signature, version and administrative checks

• Confirm each PIS/ICF page carries the correct version, date and trial identification.
• Confirm the version and date match the machine-readable Part II document list.
• Confirm electronic consent uses an electronic signature method accepted by SÚKL.
• Do not assume a sponsor platform's standard e-signature is acceptable. SÚKL expressly rejects sponsor-created signatures that do not meet its criteria.
• Confirm age-specific and capacity-specific forms use consistent versioning and are linked to the correct consent-giver.
• Confirm participant materials and recruitment materials use the current content version.
• Confirm screenshots are supplied for electronic questionnaires where required.

Readability, language and design checks

Mandatory. The standard PIS/ICF submitted for Czechia must be in Czech.

Recommended. Apply KLH-22 readability guidance. Keep wording clear, avoid unnecessary specialist terms and abbreviations and use a document length and font size suitable for the population. SÚKL recommends language review.

For minors, match the national age-specific style. SÚKL's KLH-22 recommends simpler, shorter information for ages 12 to 14 and allows the 15 to 17 version to approach adult length while still adapting the content to adolescents.

For foreign nationals, do not translate an unapproved English master directly for use in Czechia. SÚKL requires a certified translation of the approved Czech version and submission through CTIS as a non-substantial amendment.

Final release check

Before upload, compare the patient-facing package with the Czechia Part II document checklist. The final check should confirm the correct Czech forms, correct population variants, correct optional-consent logic and a complete national Part II document set rather than only clean wording.