CTIS Clinical Trial Submission in Romania: Part II Guide Hub

Romania CTIS Part II guide directory

EU CTIS Part II Document Checklist

Use this first to identify the core Part II documents, Romania-specific forms, language rules and signature requirements. Read the EU CTIS Part II Document Checklist guide

Patient Information and Consent Requirements

Use this for the main Romanian Patient Information Sheet and Informed Consent Form package, including consent procedure, signatures and participant-facing language. Read the Patient Information and Consent Requirements guide

Patient-Facing Document QC Checklist

Use this before submission to check consistency, consent logic, privacy, biosamples, signatures, versions and population coverage. Read the Patient-Facing Document QC Checklist guide

Healthy Volunteer Consent Requirements

Use this for healthy-volunteer studies, especially Phase I trials where Romania has additional requirements for authorised Phase I units. Read the Healthy Volunteer Consent Requirements guide

Minor Consent and Assent Requirements

Use this when children or adolescents can participate and you need representative consent and age-appropriate participant information. Read the Minor Consent and Assent Requirements guide

Limited-Capacity Participant and Legal Representative Consent Requirements

Use this when adults may lack capacity to provide informed consent or may regain capacity during the trial. Read the Limited-Capacity Participant and Legal Representative Consent Requirements guide

Emergency Enrollment Consent Requirements

Use this when the protocol may enroll a participant in a medical emergency before prior informed consent can be obtained. Read the Emergency Enrollment Consent Requirements guide

Impartial Witness Consent Requirements

Use this when a participant can consent but cannot write, so consent must be documented with an impartial witness. Read the Impartial Witness Consent Requirements guide

Pregnancy Follow-Up Consent Requirements

Use this for pregnancy follow-up involving a pregnant participant or the pregnant partner of a trial participant. Read the Pregnancy Follow-Up Consent Requirements guide

Secondary Use Consent Requirements

Use this when optional future research, secondary data use or future use of biological samples is planned. Read the Secondary Use Consent Requirements guide

Main national differences to plan for

Romanian participant-facing documents

Mandatory. Participant-facing information and recruitment materials used in Romania should be in Romanian. Romania permits documentation that is not intended for participants to be submitted in English. This lets sponsors keep many administrative and scientific documents in English while localising documents that participants read or use. The Romania patient information and consent guide explains the practical document set.

National recruitment and informed-consent procedure

Mandatory. Where applicable to the Part II dossier. Order 3390/2022 contains a Romanian recruitment and informed-consent procedure form. It asks who identifies and approaches potential participants, who obtains consent, when and where consent is taken, how understanding is checked, how non-Romanian speakers are handled and how withdrawal is managed. It also contains sections for adults lacking capacity, minors, impartial witnesses and emergency trials.

Current template transition

EudraLex Volume 10 now lists recruitment and informed-consent procedure template v2.0, with full implementation from 1 September 2026. Order 3390/2022 states that the Romanian forms are republished when the corresponding European Commission templates are updated. For submissions around this transition, check the current ANMDMR form immediately before filing rather than relying only on the May 2022 form contained in Order 3390/2022.

Central ethics assessment

CNBMDM performs the ethical assessment for clinical trials in Romania. It reviews participant information and consent, recruitment, investigator and site suitability, insurance, compensation and financial arrangements. ANMDMR coordinates the national procedure and communicates the final decision through CTIS.

Romanian site and investigator forms

Romania's national methodology includes forms for the principal investigator curriculum vitae, declaration of interests, site suitability and participant compensation. The site suitability document is signed by the principal investigator, the head of the relevant department or clinic and the hospital or institution manager.

Special populations

Romania does not publish fixed CTIS-specific assent age bands in Order 3390/2022. For minors who can form an opinion and assess the information given to them, their agreement to participate is mandatory in addition to consent from the legally designated representative. For an adult lacking capacity who can still form an opinion and assess the information, both that participant and the legal representative sign the informed-consent form.