Initial clinical trial applications and substantial amendments submitted under Directive 2001/20/EC
A formal application and the following documents must be submitted to the Ethics Committee:
- Cover letter, which includes study title, protocol number, name(s) of principal investigator(s), contact details of the study centre(s), list of submitted documents and contact details of the applicant.
- Informed consent form(s)
- CV of the principal investigator and the principal investigator(s)
- All questionnaires, scales and instruments used by the subjects.
- All materials on the study (invitations, advertisements, newsletters) aimed at the subjects.
All materials provided to subjects should be provided in all languages in which they are intended to be used.
Clinical trial applications submitted under Regulation no 536/2014 (Part II documents)
Ethics committee for medicinal products accepts European Commission templates (Part II document templates).
Additional information regarding data protection is avalable here (in Estonian only):
Isikuandmete kasutamine teadusuuringutes | 23.51 KB | pdf
Please send CTA documentation (submitted under directive) and queries regarding ethics to ethics@ravimiamet.ee.
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 2022:
- May 9;
- June 20;
- July 11;
- August 8;
- September 12;
- October 10;
- November 14;
- December 12.
We kindly ask you to submit the initial application for a clinical trial with documentation no later than 10 calendar days before and the request for substantial change with documentation 7 calendar days before the meeting of the Ethics Committee.
Contact details of the ethics committee:
Nooruse 1, 50411 Tartu
ethics@ravimiamet.ee
Viimati uuendatud: 28.04.2022