Clinical trials are inseparable from today’s medical research. After composing an exact study plan, the permission to start a clinical trial must be required from one of the two independent ethics committees and the State Agency of Medicines.
Participation in international clinical trials is a gained recognition of investigators and hospital because both have to be on the international level. Doctors who are involved in medical research have to pass GCP (Good Clinical Practice) training, where principals of clinical trials are handled, also knowing of legal aspects of Estonian and European laws connected to the conduction of clinical trials studied.
Additional information for a clinical investigator:
Clinical Research Centre provides assistance to investigators in randomizing a clinical trial. We can offer a patient randomization and provide the investigator with sealed code envelopes (envelope that contains information about receiving treatment per each study patient).
Study randomization can also be performed in REDCap software. However, this requires a random sequence to be created outside of the software. Contact our database specialists for more detailed instructions.
According to the Personal Data Protection Act, which entered into force on 15 January 2019, it is not necessary to apply for separate permission from the Data Protection Inspectorate for retrospective studies, the approval of the Ethics Committee is sufficient.
Specialist of the Clinical Research Centre and pediatric investigators of Tartu University Hospital have developed informed consent forms for both adult and pediatric studies. It makes it easier for academic clinical investigators to develop an informed consent form for study patients. The samples of the forms are regularly updated according to the feedback received from the Ethics Committee. The samples are in use for interventional and non-interventional clinical trials.
Informed consent to participate in the study can be given by an adult parent or by the legal representative of the child. In addition, the child should be explained the study according to their age and ask their informed consent to participate in the study. Information sheets and informed consent forms are prepared for children aged 7 to 12 and 13 to 17.
The Clinical Research Centre has developed forms to support academic research. Contact us if you need help drafting them.