Latvia CTIS Part II Guides

Choose the right Latvia guide

Latvia CTIS Part II document checklist

Use this checklist to identify the required and conditional Part II documents, their language, the applicable template, and whether a signature is needed at submission.

Read the Latvia CTIS Part II document checklist

Latvia patient information and consent requirements

Start here when drafting the main adult Participant Information Sheet and Informed Consent Form, including Latvia-specific contacts, identifiers, language, and signature logic.

Read the Latvia patient information and consent requirements

Latvia patient-facing document QC checklist

Use this guide for a final protocol-to-document, privacy, consent, translation, version, and population-coverage review.

Read the Latvia patient-facing document QC checklist

Latvia healthy volunteer consent requirements

Use this variation when the trial enrolls healthy volunteers and the standard information sheet needs volunteer-specific risk, payment, screening, and medical-care wording.

Read the Latvia healthy volunteer consent requirements

Latvia minor consent and assent requirements

Use this guide for the 0 to 13 and 14 to 17 age pathways, child information, the legal representative's consent, the child's own written consent from age 14, and re-consent at adulthood.

Read the Latvia minor consent and assent requirements

Latvia limited-capacity participant and legal representative requirements

Use this variation when an adult cannot provide informed consent or has a court-defined restriction of legal capacity.

Read the Latvia limited-capacity participant and legal representative requirements

Latvia emergency enrollment consent requirements

Use this guide only when the protocol proposes enrollment in an urgent, life-threatening situation under the narrow deferred-consent conditions in Article 35 of the Clinical Trials Regulation.

Read the Latvia emergency enrollment consent requirements

Latvia impartial witness consent requirements

Use this guide when a participant can consent but cannot write, so the alternative consent method and impartial-witness process must be documented.

Read the Latvia impartial witness consent requirements

Latvia pregnancy follow-up consent requirements

Use this guide for protocol-driven pregnancy follow-up involving a pregnant participant or the pregnant partner of a trial participant.

Read the Latvia pregnancy follow-up consent requirements

Latvia secondary-use consent requirements

Use this variation when optional future research, secondary data use, or storage and future use of biological samples falls outside the main trial purpose.

Read the Latvia secondary-use consent requirements

Main Latvia differences

Participant-facing documents must be in Latvian and understandable to the intended population. Latvia's national Part II overview asks the main consent set to identify the study centre and data controller and to provide contact details for ZVA, the assigned ethics committee, and the Data State Inspectorate. The Latvia patient information and consent guide explains how to assemble the standard document set.

For minors, a legal representative gives written consent. From age 14, the minor must also give written consent. Younger children should be involved according to age and maturity, and Latvia recommends seeking their own agreement where appropriate. The Latvia minor consent and assent guide sets out the two national age pathways.

Latvia requires the EU recruitment and informed-consent procedure template, declaration-of-interest template, site-suitability template, and participant-compensation template. The site-suitability statement must be dated and signed by an authorised representative of the healthcare institution or another appropriately authorised person in charge. The Latvia Part II document checklist maps each item to its CTIS location.

The insurance evidence must identify the study and comply with Latvia's mandatory civil-liability insurance rules. Latvia also expects a draft contract and trial budget for each investigator or site. These documents should be ready for the initial Part II submission.