Romania CTIS Part II Document Checklist

Participant information and informed consent

Mandatory. Submit the blank Patient Information Sheet and Informed Consent Form that will be used in Romania. They should be in Romanian when intended for Romanian participants. They are not signed by participants at CTIS submission. The participant or legally designated representative and the person conducting the consent interview sign and date the consent when consent is obtained. The Romania patient information and consent guide covers the consent procedure and content.

Conditional. Add separate or adapted documents when the trial includes minors, adults lacking capacity, emergency enrollment, participants unable to write, pregnancy follow-up or optional future research. The Romania patient-facing QC guide helps confirm that every planned population has the correct document.

Recruitment and consent procedure

Mandatory. Romania's Order 3390/2022 contains the national form "RO_Procedura de recrutare şi obţinere a consimţământului informat". It asks how potential participants are identified, approached and informed, who obtains consent, when consent occurs, how comprehension is checked and how withdrawal is handled. Complete the sections that apply to your population and recruitment pathway.

EudraLex Volume 10 now lists a v2.0 recruitment and informed-consent procedure template, with full implementation from 1 September 2026. Order 3390/2022 requires Romanian forms to be republished when European Commission templates are updated. Check the ANMDMR version immediately before filing during this transition.

Conditional. . Recruitment materials. If posters, advertisements, social media materials, patient-organisation materials or other recruitment content will be used, include them in Romanian. Electronic recruitment resources require prior CNBMDM approval. The recruitment procedure should describe how responses are managed and what happens when a potential participant does not qualify.

Investigator documents

Mandatory. . Principal investigator curriculum vitae. Romania publishes a national CV form in Order 3390/2022. It includes relevant clinical-trial experience and training and contains date and signature fields. Use the current national form required for the Romanian site.

Mandatory. . Principal investigator declaration of interests. Romania publishes a national declaration-of-interests form. It should disclose economic, institutional or personal interests that could affect impartiality. Complete and sign the applicable form.

Site suitability

Mandatory. Submit a separate site suitability description for each Romanian site. The national form covers facilities, staff, participant numbers and operational capability. It is signed by the principal investigator, the head of the relevant department, clinic or section and the hospital or institution manager.

Conditional. . Phase I or bioequivalence site authorisation. A Romanian healthcare unit conducting Phase I or bioequivalence studies requires the relevant ANMDMR authorisation. This is an additional national operational requirement for those units, not a general requirement for every site.

Insurance and indemnity

Mandatory. CNBMDM evaluates insurance or indemnity arrangements covering trial-related injury or death. Include the evidence required under the Clinical Trials Regulation and the applicable Romanian arrangements.

The participant information should describe the injury and insurance pathway in plain language and match the submitted evidence.

Participant compensation

Mandatory. Romania publishes a national compensation form in Order 3390/2022. It asks whether participants, parents, carers or legal representatives receive reimbursement or compensation for travel, accommodation, meals, loss of earnings, cash or non-cash payments.

If the same information is already stated in the participant information sheet, the form allows a cross-reference. Make sure the cross-reference is precise and the amounts or calculation logic agree.

Financial arrangements

Mandatory. CNBMDM reviews the description of trial financing and the general financial arrangements with sites and investigators.

Order 3390/2022 calls for an unsigned form of the sponsor-site or sponsor-investigator contract containing the general clauses on payments. Do not add signatures merely because other administrative forms require them.

Data protection

Mandatory. Include the declaration required under Annex I section R of Regulation (EU) No 536/2014 confirming that personal data will be processed in accordance with Union data-protection law.

The participant privacy language should match the actual data flow and should not present trial consent as the only legal basis for all data processing.

Biological samples

Conditional. If the trial collects or stores human biological samples, Part II should explain compliance with applicable rules on collection, storage and future use.

Order 3390/2022 reproduces a biological-sample compliance template that may be used for this purpose. The template itself states that it is not mandatory. The Romania secondary-use consent guide explains future-use issues.

Payment evidence

Mandatory. Where requested by the national process. Order 3390/2022 includes a Romanian payment commitment form for ANMDMR invoices. Check the current ANMDMR clinical-trials pages before submission because payment administration can change separately from substantive Part II requirements.

What must be signed at submission

The participant ICF is submitted blank and is signed later during the consent process. Investigator and site administrative forms that contain signature fields should be completed and signed before submission when the current national form requires it.

The sponsor-site or sponsor-investigator contract requested for Part II financial arrangements is submitted in unsigned form under Order 3390/2022.

For minors and adults lacking capacity, do not confuse submission signatures with consent signatures. The Romania minor consent guide and Romania limited-capacity guide cover the participant-level signature rules.

Country submission resources

The most useful sources are the ANMDMR clinical-trials legislation page, Order 3390/2022 with its annexed forms, the CNBMDM regulation, EudraLex Volume 10 and the current CTIS Sponsor Handbook. The Romania CTIS hub links the full guide series.