Estonia – Regulation 23 - Conducting Clinical Trials

(2) The sponsor of the clinical trial shall submit a report in writing once a year on serious adverse reactions of the investigational medicinal product occurring in any country.

§11. Collection and storage of data relating to the conducting of trial

(1) The persons conducting the trial and the sponsor or the representative of the sponsor shall ensure the completeness and accuracy of the information collected in the course of the trial, the possibility of comparison of this information with original sources, the functioning of the quality control system and the protection of the personal data of the trial subjects.

(2) The principal investigator shall ensure the preservation of essential information collected in the course of the trial, including source information for at least fifteen years after the end of the trial.

(3) The sponsor and the persons conducting the trial shall ensure the preservation of all information concerning the investigational medicinal product for the time of validity of the marketing authorisation of the medicinal product or for at least five years after the termination of the use of the medicinal product for research purposes unless the sponsor or his or her representative and the person conducting the trial have agreed otherwise.

§12. Termination of trial

(1) The sponsor of the trial, the principal investigator or the manufacturer of the investigational medicinal product shall terminate the trial immediately if in his or her opinion the danger to the life and health of the subjects is too serious.

(2) If the Agency of Medicines decides to suspend or terminate the trial on the basis of section 98 of the Medicinal Products Act it shall promptly notify, together with the reasons, the competent authorities of other Member States, the ethics committee, the European Medicines Agency and the European Commission, in the case of a trial of a veterinary medicinal product also the Ministry of Agriculture.

(3) If the trial is prematurely terminated the co-ordinating investigator shall notify within fifteen calendar days in writing the Agency of Medicines and the ethics committee and in the case of a trial of a veterinary medicinal product, the Agency of Medicines and the Ministry of Agriculture, and shall provide an explanation on the reason for termination of the trial.