Estonia CTIS Part II Document Checklist

Recruitment arrangements

Mandatory. Describe how participants will be identified and recruited. Use the European Commission Informed Consent and Patient Recruitment Procedure template. If recruitment materials such as advertisements, letters, posters or digital content will be used, submit the relevant material and explain the process.

All recruitment materials used in Estonia must include the EU CT number. Compensation information belongs in the Informed Consent Form rather than recruitment advertising.

At CTIS submission, recruitment materials are submitted as approved draft materials and are not signed by prospective participants.

The Estonia patient-facing document QC checklist is useful for checking recruitment claims against the protocol and consent package.

Subject information and informed consent

Mandatory. Submit the participant information and informed consent materials and describe the consent procedure. Estonia requires information aimed at participants to be in Estonian. If another language will be used with participants, provide that language version as well.

The State Agency of Medicines and the Ethics Committee publish an Estonia-specific Subject Information and Informed Consent Form template. The national ethics guidance asks sponsors to use "participant" instead of "patient" and to include the EU CT number on all materials directed to participants.

The blank PIS/ICF submitted in CTIS is not signed by participants at submission. When consent is later obtained, Regulation (EU) No 536/2014 requires the consent to be written, dated and signed by the participant or legal representative and by the person conducting the consent interview. Estonia permits a legally valid digital signature.

Operational CTIS note. From 27 April 2026, Ravimiamet instructs sponsors to submit Estonian-language patient-facing materials in Section R of Part II instead of Section D of Part I, except for mononational trials. For multinational trials, the English patient-facing version remains in Part I under the current EU Q&A. Keep the document naming and language version clear so assessors can match the materials.

The Estonia patient information and consent guide covers the drafting and signature logic in detail.

Suitability of the Principal Investigator

Mandatory. Submit an English CV for the Principal Investigator at each trial site. Estonia requires the CV to be dated and signed by the Principal Investigator and no more than six months old.

Include information on the investigator's most recent Good Clinical Practice training and the year the certificate was issued. Ravimiamet states that the certificate itself does not need to be submitted when the relevant training information appears in the CV.

A declaration of interests for the Principal Investigator must also be submitted. Estonia accepts the European Commission Investigator Curriculum Vitae and Declaration of Interest templates.

Ravimiamet requires a risk-based training approach for study-team members and states that all actively involved team members must be trained and certified in ICH E6(R3) by September 2026.

Suitability of the trial site

Mandatory. Submit the European Commission Site Suitability Form for each Estonia site. Use the legal name of the study centre. A commonly used English name may be added in parentheses.

The form must be signed by a person legally authorised by the study centre. Estonia accepts manually signed paper and digital signatures. CTIS does not accept the Estonian .asice digital-signature container, so a PDF may be uploaded while the original .asice file is retained at the study centre.

Insurance or indemnification

Mandatory in the usual commercial pathway. Submit proof of insurance cover or indemnification. The Estonia insurance certificate must include the EU CT number, Estonia as the country, the insurance period and the insured amount.

Conditional academic exemption. Ravimiamet states that additional private insurance is not required for certain academic studies when the participant is covered by the national health insurance system and the statutory conditions are met. Do not apply this exception without confirming eligibility under the Medicinal Products Act and Health Insurance Act.

Financial and other arrangements

Mandatory. Use the European Commission Compensation for Trial Participants template and provide transparent information on the trial budget. Estonia allows the per-participant fee to be used as the basis if the breakdown is explained.

Confirm that trial-specific services will not be billed to the Estonian Health Insurance Fund.

Participant reimbursement and any compensation must also be explained in the ICF. Estonia requires reimbursement of unavoidable direct trial-related expenses and has specific restrictions on payments to minors, incapacitated participants, their representatives, pregnant women and breastfeeding women.

Fee and invoice information

Mandatory administrative information. Estonia does not require a sponsor to prepay the specialised assessment fee before the application is accepted for evaluation. Instead, provide the invoice recipient's details, including postal address and one organisation email address based on the CTIS LOC code, plus the email address for the decision recipient.

The State Agency of Medicines issues the invoice within 10 days after the application is accepted for evaluation.

Conditional exemption. Academic sponsors and certain orphan-medicinal-product trials may qualify for statutory fee exemptions. Confirm the current Medicinal Products Act conditions before relying on an exemption.

Data protection

Mandatory. Submit the EU statement on compliance with Regulation (EU) 2016/679 in the CTIS Form section. Estonia also requires the sponsor to explain the relevant data-protection aspects in detail in the participant information and consent materials.

Ravimiamet recommends allowing separate consents in the participant information form for participation in the trial and for use of pseudonymised health data or biological samples. This should be drafted carefully so ethical trial consent is not confused with the legal basis for personal-data processing under the General Data Protection Regulation.

Biological samples

Conditional. If biological samples are collected, stored, transported or retained, submit the European Commission Compliance with Applicable Rules for Biological Samples form where appropriate.

Estonia asks the sponsor to describe what is collected, whether material is pseudonymised or anonymised, how it is transported, where it is stored, how long it is stored in years and when it will be destroyed.

Optional future use should be separated from the main trial where appropriate. The Estonia secondary use consent guide explains that distinction.

Population-specific consent documents

Conditional. Add separate or adapted participant materials when the protocol includes populations or procedures that cannot be covered safely by the default adult ICF.

Relevant Estonia guides include:

Return to the Estonia CTIS hub for the complete guide set.