Czechia CTIS Part II Impartial Witness Consent Requirements

When an impartial witness is used

Conditional. Under Article 29, use an impartial witness when the participant is unable to write and consent must be recorded by an appropriate alternative means.

SÚKL's KLH-22 also describes a witness procedure when a participant cannot read. The practical objective is to confirm that the information was communicated, questions were addressed and the participant actually agreed.

A witness is not required simply because a form is complex or because the investigator would prefer another signer.

Witness independence

Mandatory when the witness pathway is used. The witness must be independent of the study team for the SÚKL situations described in KLH-22.

Do not use a study-team member as the independent witness merely because that person was present during the consent discussion. The Part II dossier should explain how the witness will be selected when the procedure is planned.

Annex I to the Clinical Trials Regulation specifically requires information on the reason for using an impartial witness, the selection of the witness and the procedure for obtaining consent.

Participant unable to write

When a participant understands the information and can decide but cannot physically write, Article 29 permits an alternative means of recording consent in the presence of at least one impartial witness.

The witness signs and dates the informed-consent document to attest to the consent process. The participant should remain the decision-maker and should receive the same substantive information as another participant.

SÚKL's KLH-22 recommends documenting the witness's name, date and signature and confirming that the approved consent procedure was followed.

Participant unable to read

For a participant who cannot read, KLH-22 describes an independent witness who confirms that the participant information was read to the participant and that the investigator provided further information and answered questions.

If the participant can physically sign, the participant still signs the consent record. The witness signature documents the reading and explanation process rather than replacing the participant's decision.

Required patient-facing documents

Conditional. The Czech PIS/ICF should include an appropriate witness signature or attestation section when the protocol population makes the witness pathway relevant.

Do not add a witness signature line to every form without a defined use case. The submitted document should make the roles of participant, legally designated representative, witness and interviewer unambiguous.

For participants who also have limited decision-making capacity, separate physical inability to sign from legal inability to consent. Use the limited-capacity consent guide where a representative is legally required.

Consent procedure and signatures

Submit the blank witness-enabled form in CTIS. No witness signs at application submission.

During trial conduct:

• the participant or legally designated representative gives the legally relevant decision
• the independent witness observes the required process
• the witness signs and dates the record where the witness pathway requires it
• the person conducting the consent interview signs and dates the consent record under Article 29
• the participant or representative receives a copy

The witness should not be described as consenting on behalf of the participant unless the person separately has the lawful status of legally designated representative, which is a different role.

Czech national content

The PIS/ICF used with a witness remains a Czech participant document and should contain the same national SÚKL items as the standard form, including EU CT Number, full trial title, ethics committee email, source-record access language, results-availability statement and copy-of-consent wording.

If electronic consent is proposed for a participant with a physical limitation, confirm that the actual signature method meets SÚKL's accepted electronic-signature criteria and that the witness process is still workable.

Use the Czechia patient-facing QC checklist to confirm that witness wording is not confused with representative consent or emergency enrollment.