Germany CTIS Impartial Witness Consent Requirements

When the witness pathway applies

Use it when the participant has consent capacity and can receive, understand, consider, and communicate a decision but is unable to write in the usual way.

Possible reasons include a physical impairment, injury, paralysis, or another practical inability to write. Assess the person's capacity separately from the physical limitation.

Do not use this pathway:

• because the participant does not understand German
• because translated documents are unavailable
• because the person lacks consent capacity
• because a legal representative is unavailable
• to solve an emergency-enrollment situation

Those cases require translation, legal-representative, or Article 35 procedures.

Required documents

Standard participant information

Mandatory. Provide the approved German information in an accessible form. Depending on the participant, that may require reading the document aloud, an accessible electronic format, assistive technology, or another communication support.

Adapted consent form

Mandatory when the scenario is possible. Include fields that identify the alternative means used to express and record consent, the reason ordinary writing was not possible, and the people present.

Impartial-witness attestation

Mandatory. The form should allow the witness to attest that the information and consent process occurred, the participant's decision was freely expressed, and the alternative means was recorded accurately.

K1 consent-procedure description

Mandatory. Explain how the site assesses capacity, selects an impartial witness, provides accessible information, records the decision, obtains signatures, gives the participant a copy, and handles later re-consent.

Consent procedure

The physician conducting the consent interview provides the full information and answers questions. The impartial witness is present for the informed-consent process required for the alternative-recording route.

The participant communicates the decision through the approved alternative means. The method should be reliable, documented, and suitable for the person's abilities. The witness should not make the decision or answer on the participant's behalf.

Signatures and dating

The blank adapted form is submitted unsigned in CTIS Part II. When consent is obtained:

• the physician who conducted the interview signs and dates the consent
• the impartial witness signs and dates the attestation
• the participant signs by the approved method where possible, or the form records why and how the decision was expressed
• the participant receives a signed and dated copy in an accessible form

The witness signature documents the process. It is not substitute consent.

Choosing an impartial witness

The Clinical Trials Regulation requires impartiality but does not create a German national witness form or a detailed eligibility list. Select someone whose role and relationship do not create a reasonable concern that the person is influenced by the trial team, sponsor, or outcome.

Record the witness's role and relationship sufficiently for later verification without adding unnecessary personal data to the CTIS submission copy.

Language and accessibility

The participant information must be in German unless the participant uses an approved translation into another language they understand. A language interpreter and an impartial witness perform different functions. One person should fill both roles only if the application and site process justify that the person can perform each role independently and accurately.

Accessibility changes should preserve the approved meaning. Record any on-the-spot explanation or material change and assess whether a revised document or re-consent is required.

Electronic consent

German law permits compliant electronic informed consent. An electronic method may solve some physical access problems, but it does not automatically remove the need for the Article 29 witness pathway when the participant remains unable to provide the required written or electronic record.

Describe identity, authentication, dating, copy delivery, audit trail, accessibility, and contingency arrangements in Part II when electronic consent is used.

German template position

AKEK does not list a dedicated current CTR impartial-witness model form on its medicinal-product trial page. Adapt the current adult CTR document to Article 29 and the participant's communication method without changing the underlying consent information.

Use the Germany patient-facing document QC checklist before submission.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains the complete English guide series.

Other language versions

Read this guide in German.