Ethics Committee for Medicinal Products only assesses clinical trials and PASS. The Clinical Trials Ethics Committee does not assess non-interventional observational studies – for such studies please contact the research ethics committee.
Clinical trial applications submitted under Regulation no 536/2014 (Part II documents)
Ethics Committee for Medicinal Products accepts templates issued by the European Commission (Chapter I – Part II application document templates).
List of Part II documents can be found in EU Regulation No 536/2014 Annex I, points K to R.
- K. Recruitment arrangements – To be described in detail. EU form: Informed consent and patient recruitment procedure template. All recruitment materials must include the EU CT number of the relevant clinical trial.
- L. Subject information, informed consent form and informed consent procedure – EU form: Informed consent and patient recruitment procedure template. All materials to be provided to subjects must be provided in all languages in which they are intended to be used. An ICF template is available on the Agency's website that has been approved by the ethics committee. Please use "participant" instead of "patient" throughout. All materials directed to study participants must include the EU CT number of the relevant clinical trial.
- M. Suitability of the Investigator – It is compulsory to submit a CV in English, dated and signed by the Principal Investigator of the trial site. CV must not be older than 6 months. Please include in the CV information on the most recent GCP training completed, including the year the GCP certificate was issued. It is not needed to submit the GCP certificate itself if the relevant information is included in the CV. A risk-based approach must be applied to the training of team members, i.e., all persons actively involved in the study must be trained in R3 in a timely manner to perform their duties. By September 2026, all study team members must be trained and certified in ICH E6 (R3). Also submit a declaration of interests from the Principal Investigator. EU forms: Investigator Curriculum Vitae template and Declaration of interest template.
- N. Suitability of the facilities – EU form: Site suitability form. Please use the legal name of the trial site; the 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 digital signatures and manually signed paper. CTIS does not allow upload of .asice files, therefore it is accepted in CTIS to upload a .pdf file; however, the original .asice file must be available at the study centre.
- O. Proof of insurance cover or indemnification. The certificate must include the EU CT number, country, insurance period, and amount. In case of academic studies, no additional (private) insurance cover is required if the study participant is insured under the national health insurance system (Health Insurance Act § 26(7)).
- P. Financial and other arrangements – EU form: Compensation for trial participants. Transparent information on the budget of the trial must be provided. The fee per patient can be taken as a basis and a description of how it is broken down. It should also be confirmed that no trial-specific services will be billed to the Estonian Health Insurance Fund.
- Q. Proof of payment of fees – Please provide details of the recipient of the invoice (incl. postal address and a single email address for the organization, based on the LOC code) and the email address of the recipient of the decision. SAM will issue an invoice for the specialised assessment fee within 10 days after the clinical trial application has been accepted for evaluation. The sponsor may be exempt from the evaluation fee if the requirements of § 997 (3) (which may apply to academic studies) or § 997 (4) (in the case of an orphan drug) of the Medicinal Products Act are met.
- R. Proof that data will be processed in compliance with Union law on data protection. EU form is submitted in the Form section of CTIS: Template statement on compliance Regulation (EU) 2016/679. In addition, the study sponsor must ensure that all data protection aspects are explained in detail in the patient informed consent form. It is recommended that the patient can give two consents in the information form: one for participation in the study and one for the use of their health data/biological samples in pseudonymised form.
In addition: Where appropriate, it is also necessary to submit a description of the handling of biological samples, EU form: Compliance with applicable rules for biological samples. Please describe what will be collected, how it will be collected (pseudonymised or anonymised), how it will be transported, where it will be stored, how long it will be stored (years) and when it will be destroyed.
Training materials for sponsors - for understanding Clinical Trials Regulation 536/2014 use Quick guide for sponsors and Questions and Answers Document; when submitting documents in CTIS use Sponsor handbook and Best practice guide naming of documents in CTIS.
For country-specific language requirements, please refer to Annex II of the European Commission's Eudralex vol 10 Questions and Answers Document.
Enquiries concerning the requirements of Part II documents of Regulation (EU) No 536/2014 and questions for the ethics committee should be sent electronically to [email protected].
Members of the ethics committee:
|
Elli Asser, MD |
Chairman of the committee; neurosurgeon at North Estonia Medical Centre Foundation |
|---|---|
| Laura Lilles-Heinsar | Vice-chairman of the committee; personal at Institute of Philosophy and Semiotics, Centre for Ethics (University of Tartu) |
|
Eeva Liisa Linnamägi, MD |
Resident physician in internal medicine at the University of Tartu Hospital |
| Teele Lember | Research lawyer at Tallinn University of Technology |
| Janek Kapper | Founder and board member of the Estonian Inflammatory Bowel Disease Society |
| Jaanus Korjas, MD | Anesthesiologist and chief physician of intensive care at East Tallinn Central Hospital |
Q&A
General principles
Participation in a clinical trial should not incur any costs for the subject. Participants in the same trial will be compensated on an equal basis.
The same rules apply to (1) academic sponsors and commercial sponsors, and (2) patient participants and healthy participants.
The purpose of the compensation must not be to motivate participation in the trial; the compensation must not influence the potential participant’s decision to consent. The compensation must not compensate for the risk that the participant takes by participating in the trial. The amount of compensation must not depend on the level of risk.
Information about the compensation is provided in the Informed Consent Form, not in advertising and recruitment materials.
Reimbursement of expenses
The participant in the trial must be reimbursed for unavoidable expenses incurred directly as a result of participating in the trial.
Expenses that are incurred in addition to the costs associated with a regular medical visit will be reimbursed. For example, if the study visits coincide with a regular medical visit, transportation costs will not be reimbursed.
Reimbursable expenses may be based on justified needs, such as transportation, parking, food, accommodation, pregnancy tests and/or contraceptives in studies where participation is not permitted while pregnant.
Expenses will be reimbursed to a reasonable extent and based on expense documents.
In the clinical trial application, it is necessary to justify which expenses need to be reimbursed, and the principles of compensation must be explained to the participant in the Informed Consent Form.
Other benefits
Participants who are incapacitated and their representatives, minors and their representatives, pregnant women and women who are breastfeeding may not be paid any compensation for participating in the trial other than by reimbursement of direct costs.
Competent participants may be compensated for inconvenience and burdensome procedures (e.g., number of visits/time spent on visits, lifestyle restrictions, keeping diaries, filling in questionnaires, use of technological tools, use of applications) in proportion to the participant's contribution and time spent.
The amount of compensation of time should be based on the minimum wage in force in Estonia in the year the trial was initiated. The compensation may also be non-monetary (e.g., gift card, souvenir), but not greater value than the minimum wage in proportion to the time spent by the participant.
Compensation may be paid to participants if the need for compensation and the amount of compensation are justified in the clinical trial application and the justifications have been approved by the Ethics Committee for Medicinal Products. The application must describe the method of payment and when and how the participants will be informed about the compensation. The application shall also describe how the benefits, in case of discontinuation of the trial, will be dealt with. It is not allowed to offer the participant an additional compensation for completing the trial, or to pay full compensation only if the participant completes the trial, or to withhold a larger portion of the compensation at the end of the trial in order to entice participants to remain in the trial.
The State Agency of Medicines and the Ethics Committee for Medical Products have prepared a template subject information and informed consent form, which can be used for preparing information and informed consent form for trial participants. The form is available on the State Agency of Medicines website [sama link, mis EE].
If new important information becomes available during the trial that may affect the willingness of trial participants to continue participating in the trial, it is recommended to prepare a short version of the information form for patients already involved in the trial, clearly highlighting the new information and referring to the previous version of the informed consent form, or to mark the amended text in the main version in a clearly understandable manner (e.g., in italics).
Obtaining consent remotely may be considered if it takes place via video call and e-identification. Remote consent can be given if it is possible to: 1. clearly identify the individuals involved in the informed consent process; 2. ask questions in the usual manner with the opportunity to take time before deciding; 3. all other similar opportunities and rights that would have been provided in a face-to-face interview are fully guaranteed.
A signature must be provided in a manner accepted by Estonian law. In Estonia, it is permitted to sign the consent form with digital signature.
Remote consent procedure must be justified and approved by the Ethics Committee before implementation.
Contact details of the ethics committee:
Nooruse 1, 50411 Tartu
[email protected]
Last updated: 18.03.2026
