Bulgaria CTIS Part II Patient Information and Consent Requirements

What must be submitted in Part II

Mandatory. Submit all written information given to the potential participant, or to the legally designated representative where applicable, before the decision to participate. Submit the written ICF together with that information.

For Bulgaria, the Patient Information Sheet and ICF must be in Bulgarian. The BDA also requires the Bulgaria version in English. Keep the two versions aligned in content, document identity, version and date so the Bulgarian text can be assessed against the intended country wording.

The current EudraLex recruitment and informed-consent procedure template v2.0 is highly recommended for new Part II submissions as of 23 August 2026 and moves to full implementation on 1 September 2026.

Bulgarian language and readability

Mandatory. The participant-facing version is Bulgarian. A technically correct translation is not enough if the text remains difficult for a participant to understand.

Bulgarian Good Clinical Practice rules require the oral and written trial information, including the ICF, to avoid medical jargon and to be sufficiently accessible for the participant, legal representative and, where needed, independent witness. The participant or representative must have enough time and opportunity to discuss the trial and decide whether to participate.

Use short sentences, define necessary clinical terms and make practical consequences clear. For example, explain what randomisation means for the participant rather than only naming the method.

Main content of the Bulgaria Patient Information Sheet and ICF

The participant documents should cover the trial-specific information required for informed consent and Good Clinical Practice. Depending on the protocol, this normally includes:

• that the activity is research and the purpose of the clinical trial
• the investigational treatment and, where applicable, the chance of being assigned to each treatment
• trial procedures, including invasive procedures
• participant responsibilities and which aspects are experimental
• reasonably foreseeable risks and inconveniences
• risks to an embryo, fetus or nursing infant where relevant
• reasonably expected benefits, or a clear statement when direct clinical benefit is not expected
• available alternatives and their important risks and benefits
• compensation or treatment available for trial-related injury
• planned payment or reimbursement, where applicable
• expected participant costs, if any
• the voluntary nature of participation and the right to refuse or withdraw
• access to source medical records for authorised trial oversight and verification, with confidentiality protections
• protection of identity and confidentiality
• new information that may affect willingness to continue
• contacts for trial information, participant rights and trial-related injury
• foreseeable reasons participation may end
• expected duration of participation
• approximate number of trial participants

Country-specific information on Bulgarian insurance, compensation, contacts and data processing should agree with the Part II administrative documents. The Bulgaria Part II document checklist helps cross-check those documents.

Consent, signatures and dating

Mandatory during trial conduct. Under Regulation (EU) No 536/2014, informed consent is written, dated and signed by the person who conducts the consent interview and by the participant. When the participant cannot legally consent, the legally designated representative signs instead, subject to the applicable national rules.

Bulgarian Good Clinical Practice likewise requires the participant or legal representative and the person conducting the consent discussion to sign and personally date the written consent before enrollment. The participant or representative receives a copy of the signed and dated form and the written information provided.

The copies uploaded in CTIS for ethics review are not participant-signed consent records. They are the approved document versions that will later be used at the site.

Data protection and medical-record access

The PIS and ICF should explain how personal information is handled in a way that is consistent with the trial's data-protection documentation. Bulgarian Part II also includes a sponsor or representative declaration that data will be collected and processed in accordance with the General Data Protection Regulation (GDPR).

Do not use the ICF as a substitute for the sponsor's full GDPR legal analysis. The participant document should explain the practical processing, confidentiality, access to source records, relevant recipients and participant-facing rights without making promises that conflict with the protocol or data-protection documentation.

Biological samples and future research

Conditional. If the protocol includes collection or storage of human biological samples, the participant documents should clearly describe what is collected, why, how long it is kept, where it may be transferred and what happens to remaining material. Bulgaria also requires a Part II declaration on compliance with applicable rules for collection, storage and future use of human biological samples.

If future use is optional and goes beyond the main protocol, keep that choice separate from the decision to join the main trial. Regulation (EU) No 536/2014 permits a sponsor to ask for consent to scientific use of data outside the protocol, and that consent can be withdrawn. The Bulgaria secondary use consent guide explains the document logic.

Population-specific variations

The standard adult PIS and ICF should not be stretched to cover every population with one signature page.

Conditional. Healthy-volunteer trials need participant information that does not imply therapeutic need or expected treatment benefit. See the Bulgaria healthy-volunteer consent guide.

Conditional. Minors need age-appropriate information and Bulgaria-specific parent and minor consent logic. Participants under 14 and those aged 14 to 17 follow different national rules. See the Bulgaria minor consent and assent guide.

Conditional. Adults who cannot legally provide consent require a legally designated representative pathway and information adapted to the participant's ability to understand. See the Bulgaria limited-capacity participant guide.

Conditional. Emergency enrollment may allow consent after the first intervention only when all conditions in Article 35 of the Clinical Trials Regulation are met. See the Bulgaria emergency enrollment guide.

Conditional. An independent witness is used when the consent process cannot be documented through the standard reading or writing route. See the Bulgaria impartial witness guide.

Conditional. Pregnancy follow-up and partner follow-up may need separate participant-facing information where the protocol collects pregnancy, maternal, outcome or infant data beyond what the main consent covers. See the Bulgaria pregnancy follow-up guide.

No separate national standard ICF template

The current BDA Part II document list specifies what must be submitted and the language requirements, but it does not publish a single mandatory Bulgaria national PIS or ICF text template for all trials. Use the Clinical Trials Regulation, Bulgarian law, Bulgarian Good Clinical Practice and the current EU Part II procedure template to structure the trial-specific documents.

Before upload, run a final consistency check against the protocol, recruitment materials, insurance, compensation, privacy and sample-use documents. The Bulgaria patient-facing document QC checklist provides that review sequence.

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