Romania CTIS Part II Patient Information and Consent Requirements

Romanian language requirements

Mandatory. Documents intended for participants in Romania should be in Romanian. Government Emergency Ordinance 29/2022 allows documentation not intended for participants to be submitted in English, but participant-facing information is not covered by that exception.

If a participant does not speak Romanian, the national recruitment and consent procedure asks the sponsor to explain how valid informed consent will be obtained. Plan translated information and consent documents for any non-Romanian-speaking population that the protocol and sites are expected to enroll.

What the main participant information should explain

The participant information should describe the trial in language the intended population can understand. Explain the study purpose and procedures, foreseeable risks and burdens, expected benefits where applicable, alternatives to participation, the voluntary nature of participation and the right to withdraw.

Also explain trial-related injury arrangements, reimbursement or compensation, privacy and data handling, access to medical records where relevant, collection and use of biological samples, pregnancy precautions and follow-up where applicable and whom to contact about the trial or participant rights.

If the trial uses recruitment advertising, additional optional research, pregnancy follow-up or population-specific consent, those documents should be consistent with the main information sheet. The Romania patient-facing QC guide provides a final consistency check.

The Romanian consent interview

Mandatory. Under Order 3390/2022, the person conducting the interview to obtain informed consent must be a physician who is a member of the investigation team and is appropriately trained on the protocol and good clinical practice.

Romania's recruitment and informed-consent procedure asks who approaches potential participants, who obtains consent, when and where consent is taken, how privacy is protected, how much decision time is provided and how understanding is checked.

Describe the process actually planned at Romanian sites rather than copying generic wording.

Current national form transition

The May 2022 national form remains embedded in Order 3390/2022, but EudraLex Volume 10 now lists the EU recruitment and informed-consent procedure template v2.0 with full implementation from 1 September 2026.

Because Order 3390/2022 states that the Romanian forms are republished when Commission templates are updated, verify the current ANMDMR form immediately before filing during this transition.

Signature and dating rules

Mandatory. At consent, not at CTIS submission. The blank Patient Information Sheet and Informed Consent Form are submitted in the application dossier. The signed consent is created later when a participant enrolls.

EU guidance requires informed consent to be written, dated and signed by the person performing the interview and by the participant or legally designated representative when the participant cannot consent.

Conditional. If a participant can consent but cannot write, alternative means may be used in the presence of at least one impartial witness. Romania's national form specifically requires the witness to sign and date the informed-consent document. The Romania impartial-witness guide explains this pathway.

Minors

Conditional. For minors, consent from the legally designated representative is required. Romania also makes the agreement of a minor mandatory when the minor is capable of forming an opinion and assessing the information given.

Order 3390/2022 does not publish fixed CTIS-specific assent age bands. Information should therefore be adapted to age and mental maturity. The Romania minor consent and assent guide explains the process.

Adults lacking capacity

Conditional. If an adult lacks capacity, the legally designated representative provides consent under the applicable legal framework.

When the participant can nevertheless form an opinion and assess the information, Order 3390/2022 requires both the participant's signature and the representative's signature on the informed-consent form.

The national recruitment form also asks how capacity is assessed, how the representative is identified, how information is adapted and how re-consent will be obtained if capacity returns. The Romania limited-capacity consent guide covers the full pathway.

Emergency consent

Conditional. Deferred consent is available only when the trial is directly related to a medical emergency and the conditions of Article 35 of Regulation (EU) No 536/2014 are met.

Romania's national recruitment form asks why consent cannot be obtained before enrollment, how consent will be sought from the participant or representative as soon as possible and how the sponsor will ensure that a known prior objection is respected. The Romania emergency-enrollment guide explains the document set.

Compensation and insurance information

Participant documents should accurately explain reimbursement, compensation and trial-related injury arrangements. CNBMDM reviews insurance or indemnity and financial arrangements as part of the ethics assessment.

Romania's national compensation form covers travel, accommodation, food, loss of earnings, cash and non-cash benefits. For minors, adults lacking capacity and pregnant or breastfeeding participants, EU rules prohibit financial inducements beyond compensation for expenses and loss of earnings directly related to participation.

Data protection and biological samples

The participant information should distinguish consent to participate in the clinical trial from the legal framework for processing personal data.

If future or secondary research use is optional, make the optional choice clear and keep it consistent with the biological-sample and data-protection information submitted in Part II. The Romania secondary-use consent guide covers this area.

Final consent package check

Before submitting, confirm that the Romanian participant documents, recruitment procedure, recruitment materials and population-specific variants tell the same story. Check names, visits, study duration, allocation, risks, pregnancy rules, reimbursement, sample handling, privacy contacts, withdrawal and version dates.

Return to the Romania CTIS guide hub for the full Part II series.