Volunteer

Clinical trials are scientific projects that are carried out in order to find the best ways to treat or prevent diseases. They are an integral part of the process of developing new drugs and devices for the treatment and prevention of diseases.

Participants in clinical trials gain access to new experimental treatments that are not yet available to the general public and at the same time help other people by contributing to medical research.

Requirements for volunteers

• A healthy volunteer based on the results of all laboratory and instrumental studies;
• Age from 18 to 45 years;
• Absence of allergic reactions;
• Absence of alcohol and/or drug addiction;
• Negative pregnancy test (for female volunteers);
• Consent to adhere to double barrier methods of contraception (for example, condoms with spermicides).

Procedure for conducting clinical trials of the first phase and bioequivalence

• Join our group VK (https://vk.com/kb2invest) and receive the latest and most up-to-date information about the recruitment of volunteers;
• Register on the website or call the contact phone number;
• On the day of screening, visit the center for examination;
• Have a passport, SNILS, INN with you.

Screening

• Familiarization with informed consent (contains full information about the upcoming clinical trial);
• Signing an informed consent form with a medical researcher;
• Doctor’s examination, measurement of height, weight;
• Laboratory tests (clinical blood test, general urine test, biochemical blood test, blood test for HIV, syphilis, viral hepatitis B and C);
• Alcohol test;
• Urine test for abuse of drugs and narcotic substances;
• Pregnancy test (for female volunteers);
• Instrumental studies (ECG);
• According to the results of the screening, the research doctor makes a conclusion on the basis of which the volunteer is allowed or not allowed to study.

Research procedures

• Hospitalization to the center on the day before taking the drug from 17−18.00 per day according to the study schedule;
• Doctor’s examination;
• If necessary, laboratory and instrumental studies, tests for alcohol, abuse of drugs and narcotic substances, pregnancy (for female volunteers);
• Taking the drug (most often carried out from 08−09.00);
• Blood donation for the study of bioequivalence of drugs (the first blood sampling is carried out before taking the drug, the time of sampling of subsequent samples corresponds to the study plan).

Completion of the study and payment

• Payment is made immediately on the last day of participation in the study;
• The amount of payments is agreed upon before the start of the study.

Volunteer rights

• To choose whether or not to participate in clinical trials;
• The opportunity to ask the researcher all the questions of interest, get answers and have enough time to make a decision;
• To receive all the information of interest concerning the study, the drug being studied and the state of one’s own health, in full and in an accessible form;
• On the confidentiality of personal data;
• Be under constant medical supervision throughout the study, providing the necessary qualified medical care if necessary;
• For compensation for damage to health caused by participation in a clinical trial (if any).