Estonia – Regulation 23 - Conducting Clinical Trials

(11) An application for authorisation for import of an investigational medicinal product shall be submitted to the Agency of Medicines after receiving consent for conducting the trial.

(12) The principal investigator is responsible for the storage of and maintenance of records on the investigational medicinal product at the trial site.

(13) The investigational medicinal products which were not used shall be destroyed on site, delivered for destruction to a waste treatment facility who holds a corresponding activity licence or returned to the manufacturer. All the specified activities shall be documented.

§7. Commencement of trial

(1) Before commencement of a trial, a list of persons participating in the trial specified in subsections 89 (1) and (2) of the Medicinal Products Act shall be prepared.

(2) A coordinating investigator shall be appointed from among the persons conducting the trial who shall coordinate the conducting of the trial in the trial site and shall ensure the exchange of information with the Agency of Medicines and the ethics committee and, in case of veterinary medicinal products, with the Ministry of Agriculture. If the trial is conducted in several trial sites, a co-ordinating investigator shall be appointed in each of them.

§8. Protection of trial subjects

(1) A trial may be conducted only if the estimated clinical benefit and the benefit for public health justifies the risks taken and the compliance with this requirement is continuously monitored during the trial.

(2) It is not permitted to conduct gene therapy trials resulting in the change of original genetic identity of the trial subject.

(3) A trial on persons with restricted active legal capacity is permitted only if the patient group directly benefits from the trial and only if the trial is essential for proving the data which have been obtained from clinical trials on persons who are capable of giving informed consent or by other scientific methods. In addition, the trial should be directly related to the clinical condition of the person with restricted active legal capacity or to such nature of the trial as allows it to be conducted only on person with restricted active legal capacity.

(4) Depending on the trial, a doctor, dentist or veterinarian with appropriate qualifications shall be responsible for medical care provided to the trial subjects and medical decisions made in the interests of the trial subjects.

§9. Amendments to trial protocol and conducting of trial

(1) Upon conducting a trial, the trial protocol shall be closely observed which describes the scientific background and objective of the trial, the trial plan, selection of trial subjects, use of the investigational medicinal product and other treatment of trial subjects, evaluation of the efficacy and safety of the medicinal product, the methods of collecting, storing and processing of data, the statistical methods used, the system for ensuring the quality and for inspection of the trial, the ethical aspects of the trial, the financing and insurance cover of the trial and the principles of publishing of the results of the trial.