Bulgaria CTIS Part II Guide and Document Library

How the Bulgaria Part II review fits into CTIS

Part II is where the Bulgaria-specific ethical and local operational documents are assessed. The application should therefore be prepared as a national package rather than as a translation-only exercise. The BDA publishes a country list of Part I and Part II documents and language expectations, while EKKI publishes its CTIS procedures and ethics information.

A second practical point is timing. The European Commission has published version 2.0 of the harmonised recruitment and informed-consent procedure template. As of this review date, 23 August 2026, its use is highly recommended for new Part II submissions. The transition period ends on 1 September 2026, when full implementation starts. Sponsors preparing a submission close to that date should build the dossier on the current template rather than an older version.

Bulgaria CTIS guide directory

Bulgaria CTIS Part II Document Checklist

Use this guide to identify the main Bulgaria Part II documents, language requirements, signature points and national templates. https://trialagents.com/ctis/bulgaria/en/part-ii-document-checklist

Bulgaria Patient Information and Consent Requirements

Use this guide for the standard Bulgarian Patient Information Sheet and Informed Consent Form, including language, content and signature rules. https://trialagents.com/ctis/bulgaria/en/patient-information-consent-requirements

Bulgaria Patient-Facing Document QC Checklist

Use this before submission to check protocol consistency, consent logic, privacy, population coverage, versions and Bulgarian-language documents. https://trialagents.com/ctis/bulgaria/en/patient-facing-document-qc-checklist

Bulgaria Healthy Volunteer Consent Requirements

Use this when the study enrolls healthy volunteers and needs consent, payment and reimbursement information adapted for Bulgaria. https://trialagents.com/ctis/bulgaria/en/healthy-volunteer-consent-requirements

Bulgaria Minor Consent and Assent Requirements

Use this for participants under 18. Bulgaria has distinct consent rules for children under 14 and for participants aged 14 to 17. https://trialagents.com/ctis/bulgaria/en/minor-consent-assent-requirements

Bulgaria Limited-Capacity Participant and Legal Representative Consent Requirements

Use this when an adult cannot legally provide informed consent and a legally designated representative is involved. https://trialagents.com/ctis/bulgaria/en/limited-capacity-legal-representative-consent-requirements

Bulgaria Emergency Enrollment Consent Requirements

Use this when the protocol relies on the emergency exception in Article 35 of the Clinical Trials Regulation and consent may follow the first trial intervention. https://trialagents.com/ctis/bulgaria/en/emergency-enrollment-consent-requirements

Bulgaria Impartial Witness Consent Requirements

Use this when a participant or legal representative cannot read or cannot write and the consent process needs an independent witness. https://trialagents.com/ctis/bulgaria/en/impartial-witness-consent-requirements

Bulgaria Pregnancy Follow-Up Consent Requirements

Use this when pregnancy outcome follow-up is planned for a trial participant or the pregnant partner of a participant. https://trialagents.com/ctis/bulgaria/en/pregnancy-follow-up-requirements

Bulgaria Secondary Use Consent Requirements

Use this when data or biological samples may be used outside the main protocol for optional future scientific research. https://trialagents.com/ctis/bulgaria/en/secondary-use-consent-requirements

Main national differences to prepare for

Mandatory. Participant information and the Bulgaria Informed Consent Form must be submitted in Bulgarian. The BDA also requires the corresponding Bulgaria version in English. Recruitment arrangements and recruitment materials must likewise be in Bulgarian. The Bulgaria patient information and consent guide explains the standard document set.

Mandatory. Bulgaria applies specific national consent rules to minors. For a child under 14, written consent is obtained from both parents or guardians. For a participant aged 14 to 17, written consent is obtained from the young person and both parents, or from the custodian where applicable. The BDA specifically requires the consent form for a 14 to 17 year old participant to contain a signature field for the minor. See the Bulgaria minor consent and assent guide.

Mandatory. Bulgaria uses a national site-suitability declaration. It must be in Bulgarian and signed by the head of the institution at the trial site. Insurance documentation must cover all proposed sites, identify the relevant structures and principal investigators, and cover at least the number of participants planned for Bulgaria in CTIS. The Bulgaria Part II document checklist brings these requirements together.

Mandatory when applicable. The BDA also expects the EU templates for investigator CV and declaration of interests, participant compensation, GDPR compliance and compliance with rules for human biological samples. Several of these may be submitted in Bulgarian and/or English according to the national document list.

Other language versions

This package contains the English Bulgaria hub and English guides. Link only to a Bulgarian-language hub after that version has been created and published.