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 ethics committee of TAI or University of Tartu.
Applications for Substantial Amendments under Directive 2001/20/EC
For applications for Substantial Amendments, it is necessary to send the completed Annex II form and to attach the track changes version(s) of the documents.
The cover letter should indicate whether the application is submitted to both the ethics committee and the SAM, and to whom the SAM will send the invoice for the specialised assessment fee. Applications for Substantial Amendments submitted to the Agency should be sent to [email protected].
Decisions on Substantial Amendments submitted to the ethics committee will be issued as an administrative decision of the Agency: the .asice container signed by the Agency will contain the approval of the 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 (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 - Informed consent and patient recruitment procedure template + recruitment materials to be used;
L. Subject information, informed consent form and informed consent procedure - 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.
M. Suitability of the Investigator - „Investigator Curriculum Vitae template. 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 provide separately the GCP certificate(s) of the Principal Investigator(s)."
N. Suitability of the facilities - Site suitability form. 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.
Two versions should be uploaded to CTIS: 'for publication' and 'not for publication'. In the version to be made public, sensitive personal data (e.g., signatures) must be masked or removed.
O. Proof of insurance cover or indemnification.
P. Financial and other arrangements - Compensation for trial participants template. 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. The submission of a declaration of interest is not mandatory.
Q. Proof of payment of fees - not applicable; SAM will issue an invoice for the specialised assessment fee within 10 days after the clinical trial application has been accepted. Please include the invoice recipient's details in the uploaded file.
R. Proof that data will be processed in compliance with Union law on data protection - Statement on compliance Regulation (EU) 2016/679 template. In addition, the study sponsor must ensure that all data protection aspects are explained in detail in the patient information leaflet. It is recommended that the patient can give two consents in the information sheet: one for participation in the study and one for the use of their health data/biological samples in pseudonymised form.
In addition: a description of the handling of 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.
Further requirements on data protection can be found here:
For country-specific language requirements, please refer to Annex II of the European Commission's Eudralex vol 10 Questions and Answers Document.
Applications for Substantial Amendments (complying with the Directive), 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:
|Katrin Kaarna, MD||Chairman of the committee; University of Tartu, Faculty of Medicine, Institute of Clinical Medicine, Head of Centre and Tartu University Hospital, head of the clinical research centre|
|Aime Keis, MD||
Vice-chairman of the committee; University of Tartu, Faculty of Medicine, Institute of Family Medicine and Public Health, Junior Lecturer in Medical Ethics
|Ruth Kalda, MD, PhD||
University of Tartu, Faculty of Medicine, Institute of Family Medicine and Public Health, Professor of Family Medicine
|Diva Eensoo, PhD||
National Institute for Health Development, Researcher (public health)
|Kadri Tamme, MD, PhD||PhD University of Tartu, Faculty of Medicine, Institute of Clinical Medicine, Lecturer in Anaesthesiology and Intensive Care|
|Oivi Uibo, MD, PhD||University of Tartu, Faculty of Medicine, Institute of Clinical Medicine, Associate Professor of Paediatric Gastroenterology|
|Kristi Lõuk||University of Tartu, Faculty of Arts and Humanities, Institute of Philosophy and Semiotics, Project Manager|
Committee meetings in 2023:
- January 23
- February 13
- March 13
- April 10
- May 8
- June 12
- July 10
- August 14
We kindly ask you to submit the application for Substantial Amendment (complying with the Directive) 7 calendar days before the meeting of the ethics committee.
Viimati uuendatud: 11.10.2023