Romania CTIS Part II Patient-Facing Document QC Checklist

Trial content checks

Confirm that participant documents use the same trial title, protocol number, investigational treatment names and study duration as the current protocol.

Check that descriptions of randomisation, placebo or comparator use, treatment assignment and the possibility of receiving no direct benefit are accurate.

Make sure visit frequency, procedures, hospital stays, remote activities, sample collection, imaging and participant burden match the protocol.

Protocol-to-document consistency

Cross-check important risks and safety procedures against the current protocol and Investigator's Brochure.

Verify pregnancy prevention, contraception, pregnancy testing and follow-up language against the protocol.

Confirm that withdrawal language does not promise deletion of data or samples where legal or scientific obligations require retention.

If an optional procedure appears in the ICF, confirm that it is genuinely optional in the protocol.

Romanian language and readability

Mandatory. Participant-facing documents intended for Romania should be in Romanian. Check that translations are complete, not only the signature page.

Use plain Romanian suitable for the intended population. Avoid unexplained scientific abbreviations. If the study includes minors or participants with impaired capacity, adapt the information to age and ability to understand.

If non-Romanian speakers may be enrolled, ensure the recruitment and consent procedure explains how valid consent will be obtained.

Consent logic checks

Confirm who conducts the consent interview at each Romanian site. Order 3390/2022 requires this person to be a physician, member of the investigation team and appropriately trained on the protocol and good clinical practice.

Confirm that the blank ICF has the correct signature blocks for every planned pathway.

If the participant cannot write, add the impartial-witness pathway. The Romania impartial-witness guide explains the required witness signature and date.

Population and document coverage

For minors, confirm representative consent, age-appropriate participant information and the capable minor's agreement. Use the Romania minor consent guide.

For adults lacking capacity, confirm how capacity is assessed, who acts as legal representative and how the participant is involved. If the participant can form an opinion and assess the information, both participant and representative signatures are required. Use the Romania limited-capacity guide.

For emergency enrollment, confirm that the protocol and national recruitment form describe why prior consent cannot be obtained and how consent will be sought without undue delay. Use the Romania emergency guide.

For pregnancy follow-up and future research, make sure the intended person and the exact data or samples being collected are clear. Use the Romania pregnancy follow-up guide and Romania secondary-use guide.

Data privacy checks

Confirm that participant-facing privacy language matches the actual data flow, including sponsor access, monitoring, transfers, retention and rights.

Separate participation consent from explanations about personal-data processing. Avoid wording that suggests withdrawal from the trial automatically erases data already lawfully collected.

Check that privacy contact details are correct for the sponsor and Romanian sites where applicable.

Biosample and secondary-use checks

List the samples collected, why they are collected, where they are analysed or stored and how they are linked to the participant.

If samples may be retained for research outside the main protocol purpose, state the future-use purpose, storage period, access and withdrawal logic clearly.

Romania's Order 3390/2022 reproduces a biological-sample compliance template that may be used in Part II and states that the template itself is not mandatory.

Compensation and insurance checks

Make sure the participant information matches the compensation form and insurance evidence submitted for Romania.

If the national compensation form references the participant information sheet instead of repeating payment details, verify that the cross-reference is exact.

For minors, adults lacking capacity and pregnant or breastfeeding participants, confirm that compensation is limited to expenses and loss of earnings directly related to participation and is not presented as a financial inducement.

Signature, version and administrative checks

Confirm every document has the correct protocol number, country, language, version and date.

Make sure signature blocks correspond to the intended consent pathway.

Confirm that the site suitability and investigator forms use the current national forms and required signatures.

Check that no participant document contains tracked changes, hidden comments or placeholder text.

Recruitment-material checks

If recruitment materials are used, confirm they are in Romanian and consistent with the approved recruitment procedure.

For electronic recruitment resources, confirm the plan reflects the requirement for prior CNBMDM approval.

Avoid claims about efficacy, safety or guaranteed benefit that go beyond the protocol and approved participant information.

Template-version check for August 2026

EudraLex Volume 10 now lists the recruitment and informed-consent procedure template v2.0, with full implementation from 1 September 2026. Order 3390/2022 says Romanian forms are republished when the Commission templates change.

For a submission around this date, verify the live ANMDMR form immediately before uploading the Part II package.

Final package check

Compare the patient-facing set against the Romania Part II document checklist and the main Romania patient information and consent guide. Return to the Romania CTIS hub if another population-specific guide applies.