Latvia CTIS Part II Document Checklist

Recruitment arrangements

Mandatory. Recruitment and informed consent procedure. Complete the EU Recruitment and Informed Consent Procedure template for the trial and upload it under Recruitment arrangements. Version 2.0 was adopted in January 2026 and applies to new Part II submissions from 1 September 2026, so it is the appropriate version for a dossier being prepared now. The Latvia overview does not require the procedure form itself to be translated into Latvian. The form is not signed at submission. Describe identification, first contact, recruiters, pre-screening, consent discussions, time to decide, and any national variations.

Conditional. Recruitment materials. Upload every advertisement, invitation, social-media item, script, leaflet, poster, video text, doctor letter, or other material used to recruit or refer potential participants. Latvia requires materials intended for participants and doctors to be in Latvian. They are submitted as final blank versions and are not signed. Explain the channel and purpose in the recruitment-procedure template.

Subject information and informed consent

Mandatory. Participant Information Sheet and Informed Consent Form. Upload the final blank Latvian version for each relevant population under Subject information and informed consent form. Identify the document type in the filename, such as adult, legal representative, 0 to 13 years, or 14 to 17 years. The blank form is not signed at submission. At enrollment, the participant or authorised decision-maker and the person conducting the consent interview sign and date the consent according to the applicable pathway.

The Latvia set must be concise and understandable. It should carry the version and date, sponsor protocol number, EU CT number, study-centre name and address, data-controller identity, and contact details for ZVA, the assigned ethics committee, and the Data State Inspectorate. The Latvia patient information and consent requirements explain the core content and signatures.

Conditional. Population-specific information and consent. Provide separate or clearly adapted documents when the trial includes minors, adults unable to consent, emergency enrollment, healthy volunteers, witness-assisted consent, pregnancy follow-up, or optional future use. From age 14, a Latvian minor and the legal representative both give written consent. The Latvia minor consent and assent guide covers the age bands.

Conditional. Other participant-facing material. Upload diaries, safety cards, instruction leaflets, visit aids, questionnaires, and similar items when they explain participation or support conduct. Patient-facing instruments used to assess protocol endpoints belong with the protocol in Part I under current EU guidance. Their required Latvian translation is uploaded in Part II using the CTIS translation route described in the current Questions and Answers. These documents are normally blank and unsigned at submission.

Investigator and site suitability

Mandatory. Principal investigator curriculum vitae. Submit one dated CV for the principal investigator at each Latvian site under Suitability of the investigator. Latvia recommends the EudraLex CV template, which may be completed in English. State the physician's specialty, workplace and position, professional certificate number and validity, and the date, version, and edition of Good Clinical Practice training. Do not upload the GCP certificate unless requested. Only the principal investigator's CV is assessed for this item. No signature is specified by the Latvia overview, but the CV must be dated.

Mandatory. Principal investigator declaration of interest. Use the English EudraLex Declaration of Interest template for each principal investigator and upload it under Suitability of the investigator. Identify the trial, investigator, institution, relevant interests, and date. Latvia makes the template mandatory. The template does not include a signature field, so a separate signature is not required unless ZVA or the assigned ethics committee requests one.

Mandatory. Site suitability statement. Submit a separate EudraLex Site Suitability Template for each Latvian site under Suitability of the facilities. The English EU template is accepted. It must identify the protocol title and sponsor protocol number, describe facilities, equipment, procedures, staff, and expertise, and list off-site institutions performing trial procedures other than laboratories and centrally provided services. An authorised representative of the healthcare institution or another appropriately authorised person in charge must sign and date it before CTIS submission.

Insurance and financial arrangements

Mandatory. Proof of insurance. Upload the insurance certificate under Proof of insurance cover or indemnification. Add the policy terms when the certificate does not contain the conditions needed for assessment. The national overview does not state a separate Latvian-language rule for these documents, but the submitted set must be understandable to the assessor. The evidence must identify the specific study. Where the document format allows, include the insured participant number and the Latvian site names and addresses. Insurance evidence is issued by the insurer and does not need a separate sponsor signature.

Latvia requires civil-liability coverage for harm to life or health caused by an act or omission of the sponsor, investigator, or healthcare institution. Cabinet Regulation No. 192 sets a minimum per-participant, per-event limit of 48 Latvian minimum monthly wages for a clinical trial and 12 minimum monthly wages for a low-intervention clinical trial. Confirm the monetary amount against the minimum wage in force when the insurance contract is concluded.

Mandatory. Participant compensation statement. Complete the EudraLex Compensation for Trial Participants template and upload it under Financial and other arrangements, even if no payment is offered. State reimbursements, loss-of-earnings arrangements, payments or non-monetary benefits, recipients, amounts, justification, and conditions. The form is not signed at submission.

Mandatory. Draft site or investigator agreement and budget. Submit a draft contract with each investigator and/or trial site and a draft trial budget showing the allocation for each investigator or site under Financial and other arrangements. The national overview does not set a separate Latvian-language rule for these drafts. A final executed contract or submission-time signature is not required by the overview, but the submitted draft must be complete enough for ethical review. Remove commercially irrelevant detail only if the ethics assessment remains possible.

Privacy and biological samples

Mandatory. Data-protection compliance statement. Upload a sponsor statement under Compliance with national requirements on data protection confirming that data will be collected and processed in accordance with the General Data Protection Regulation and Latvian law. The English EudraLex statement may be used. Latvia does not require a separate national form or publish a separate submission-time signature requirement for this statement.

Conditional. Biological-sample compliance. When biological samples are collected, stored, transferred, or retained for future use, explain compliance under Compliance with use of biological samples. Latvia recommends the English EudraLex biological-samples template. No separate submission-time signature is specified. Cover the sample types and amounts, responsible entity, locations, storage period, transfers, coding, future use, withdrawal handling, and destruction or anonymisation. Link the description to the relevant choices in the participant documents. The Latvia secondary-use consent guide explains optional future-use consent.

Final Latvia submission check

• Use Latvian for participant-facing documents and recruitment material intended for participants or doctors.
• Use version 2.0 of the Recruitment and Informed Consent Procedure template for new submissions made from 1 September 2026.
• Ensure every document has a clear title, trial identifier, version, and date where applicable.
• Match each population named in the protocol to a corresponding information and consent document.
• Confirm that the site-suitability form is signed and dated by the correct institutional representative.
• Confirm that insurance limits and covered risks meet Cabinet Regulation No. 192.
• Align reimbursement wording across the consent form, compensation template, contract, and budget.
• Keep the standard Latvia patient-facing document QC checklist as the final content review.
• Return to the Latvia CTIS Part II guide hub for population-specific pathways.