Romania CTIS Part II Impartial Witness Consent Requirements

Start with the main Romania consent requirements

The witness pathway is a variation of the Romania patient information and consent requirements.

Mandatory. Participant-facing information used in Romania should be in Romanian unless an approved alternative-language pathway is needed for a non-Romanian-speaking participant.

When an impartial witness is used

Conditional. Use the witness pathway when the participant is capable of giving informed consent but is unable to write.

Do not use a witness as a substitute for a legally designated representative when the participant lacks capacity. Those are different pathways. The Romania limited-capacity guide covers representative consent.

What the national form requires

The national recruitment and consent procedure asks:

• why an impartial witness is expected to be necessary
• how the witness will be identified
• how the site will know that the potential participant has actually given informed consent

The procedure submitted in Part II should answer these questions for the real site process.

Witness role during consent

The witness should be present for the alternative consent process so that the participant's decision can be documented.

The European Commission's current CTR Q&A states that alternative means may be used when a participant cannot write, provided the process occurs in the presence of at least one impartial witness and the details are recorded.

The approved participant information still needs to be given in a form the participant can understand.

Signature and dating

Mandatory. At consent. Romania's national form states that the impartial witness signs and dates the informed-consent document.

The person conducting the consent interview also signs and dates the consent under the standard EU documentation rule.

The participant's inability to write should be documented using the approved alternative method and the witness process described in the application.

Witness eligibility

Order 3390/2022 requires the witness to be impartial but does not publish a separate national witness-eligibility checklist in the Part II form.

Define a process that preserves impartiality and can be explained to CNBMDM without inventing additional national criteria.

Combining the witness pathway with other populations

A participant who cannot write may also be a minor or an adult lacking capacity. Do not collapse those pathways.

For a minor, apply the Romania minor consent and assent requirements in addition to any witness process that is genuinely needed.

For an emergency trial, the witness pathway may become relevant when subsequent consent is obtained. Use the Romania emergency-enrollment guide for the deferred-consent logic.

Submission package

Prepare the Romanian participant information and consent form with the appropriate witness documentation, the national recruitment and consent procedure and site instructions consistent with the approved process.

Use the Romania Part II checklist for the complete dossier and return to the Romania CTIS hub for related guides.