Bulgaria CTIS Part II Document Checklist

Required CTIS Part II documents for Bulgaria

Recruitment arrangements and recruitment materials

Mandatory when recruitment is not fully described in the protocol. Submit a document explaining the inclusion procedures and clearly identifying the first recruitment action. If advertisements are used, include copies of printed material and any audio or visual content, together with a general description of how responses will be handled and how unsuitable respondents will receive information or advice. The BDA requires these materials in Bulgarian. Each submitted recruitment document or form should carry its version and date. No separate national signature requirement is stated for the recruitment document itself.

Use the CTIS Part II recruitment-arrangements area and the current EudraLex recruitment and informed-consent procedure template where applicable. Version 2.0 is highly recommended for new submissions as of 23 August 2026, with full implementation from 1 September 2026.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit all information given to a potential participant or legally designated representative before the decision to participate, together with the written Informed Consent Form (ICF). The Bulgaria Patient Information Sheet and ICF must be in Bulgarian. The BDA also requires the Bulgaria version in English.

The forms submitted in CTIS are review versions and are not signed by participants at submission. During trial conduct, consent is signed and dated by the participant or legally designated representative and by the person conducting the consent interview. Population-specific signatures may add parents, the minor or an impartial witness. The Bulgaria patient information and consent guide explains the standard process.

Investigator suitability, CV and declaration of interests

Mandatory. Provide current information on investigator qualifications, including relevant Good Clinical Practice training, clinical trial experience and patient-care experience. Use the EudraLex investigator CV and declaration-of-interest templates. The declaration of interests must be signed by the principal investigator. The BDA accepts these documents in Bulgarian and/or English.

Planned trial-site list

Mandatory. Provide the planned trial sites, the name and position of each principal investigator and the planned number of participants at each site. The list must be submitted in Bulgarian. The BDA also asks for the site name and address and the principal investigator's name in English so that the information can be matched and used during assessment. No separate signature requirement is stated for this list.

Site suitability declaration

Mandatory. Use the Bulgaria-specific site-suitability template available from the BDA. The declaration should describe why the site is suitable for the trial, including facilities, equipment, human resources and relevant expertise. It must be signed by the head of the institution at the trial site and submitted in Bulgarian.

CTIS uses a site-suitability document category, but the Bulgaria national template takes precedence over assuming the generic EU form alone is sufficient.

Insurance or compensation mechanism

Mandatory. Submit valid insurance documentation covering sponsor and principal investigator liability as required by Bulgarian law. The BDA requires the insurance documents to include all proposed sites with the relevant departments or clinics and principal investigators. The insured participant number must be equal to or greater than the number planned for Bulgaria in CTIS. The BDA accepts Bulgarian and/or English.

If an insurance document is signed with a qualified electronic signature, submit it in a format that permits verification of the signature. The policy should be valid for the relevant trial period and national scope.

Financial and other arrangements

Mandatory. Submit a short description of trial financing and information on financial transactions and compensation paid to participants, investigators and sites. The information may be contained in draft sponsor-investigator and sponsor-institution contracts. The BDA points sponsors to the EudraLex participant-compensation template. These documents may be Bulgarian and/or English.

For healthy-volunteer studies, make sure the payment and reimbursement information is consistent with the participant-facing documents. The Bulgaria healthy volunteer consent guide explains the consent-side checks.

GDPR compliance declaration

Mandatory. Submit the EudraLex declaration from the sponsor or its representative confirming that personal data will be collected and processed in accordance with Regulation (EU) 2016/679. The BDA accepts Bulgarian and/or English. The national document list does not add a separate Bulgaria-specific form beyond the EU template.

Human biological sample compliance declaration

Mandatory when human biological samples are collected, stored or planned for future use. Submit the EudraLex declaration on compliance with applicable rules for collection, storage and future use of human biological samples under Article 7(1)(h) of the Clinical Trials Regulation. The BDA accepts Bulgarian and/or English.

If participants are being asked for optional future use beyond the main protocol, the participant-facing consent logic must also be clear. See the Bulgaria secondary use consent guide.

Bulgaria cover letter contact

Recommended. The BDA recommends naming a national contact person for the trial in the cover letter and providing telephone and email details. The national cover letter should be in Bulgarian.

Population-specific documents

Additional participant-facing documents are needed when the standard adult consent process does not cover the protocol population or use case.

Conditional. For minors, prepare age-appropriate information and the required parent, guardian or minor signature structure. Bulgaria distinguishes under 14 from ages 14 to 17. Use the Bulgaria minor consent and assent guide.

Conditional. For adults who cannot legally consent, prepare participant information adapted to the person's capacity plus a legally designated representative consent pathway. Use the Bulgaria limited-capacity consent guide.

Conditional. Emergency enrollment, impartial-witness consent, pregnancy follow-up and optional secondary use need specific participant-facing wording when the protocol uses those pathways. The Bulgaria patient-facing document QC checklist is useful for the final cross-check.

What must be signed at CTIS submission

The consent documents uploaded for review are not signed by future participants at submission. Signatures that are specifically relevant to the Part II dossier include the principal investigator's declaration of interests and the head-of-institution signature on the Bulgaria site-suitability declaration. Insurance documents must be valid and, where signed electronically with a qualified electronic signature, submitted in a verifiable format.

Other documents should not be given invented signature blocks simply because they appear in Part II. Follow the BDA list and the applicable official template.

For the complete country guide library, return to the Bulgaria CTIS hub.