Eight steps
- A call or a request. You call the clinic or leave a request on the website. The administrator tells you which studies are recruiting and books you in for a conversation. No medical information is collected through the website.
- A conversation with the investigator physician. The physician explains the aim of the study, what will happen, what the risks are and what benefit the study may bring. Ask any questions: it is part of the physician’s duty to answer.
- Informed consent. You can read the document calmly, take it home if you wish and discuss it with those close to you. Sign it only when everything is clear. More in “Informed consent”.
- Examination. The physician examines you and orders tests to check that you meet the criteria of the protocol. The decision is made by the investigator physician.
- The schedule. If you are suitable, you are told the dates of visits or admission and the rules of participation: diet, restrictions on medicines and alcohol. These rules must be followed, because both your safety and the reliability of the results depend on them.
- Taking part under the protocol. You receive the investigational product while physicians and nurses monitor how you feel and take tests at set times. Report any change in how you feel immediately.
- Finishing. A final examination is carried out at the end. If the study involved admission, you are told how to behave after discharge and when to contact the physician.
- If you want to withdraw. Participation is voluntary at every stage. Tell the physician: he or she will explain how to end participation properly.
What you must be told
Throughout the study you must be told any new information that may affect your decision. You are entitled to ask about the results of your examinations and about what happens to your data. More about your rights on the page “Safety and rights of participants”.
How to sign up
Call +7 (499) 346-21-15 or send a request.
Questions and answers
How long does taking part take?
It depends on the study. The schedule of visits, any admission and the total duration are given in the conversation before informed consent is signed and are stated in the document itself.
Do I have to stay at the clinic the whole time?
In bioequivalence studies volunteers stay in the clinic’s in-patient unit during the study periods; other studies have out-patient visits. How participation is arranged will be explained before you sign consent.
This material is general information and does not replace a physician’s advice. The decision to enrol a person in a study is made by the investigator physician.
See also
Informed consent: what to know before you sign
Informed consent is a document you sign after a doctor has explained the study in detail: its aims, procedures, risks, benefits and your rights. Sign it only when everything is clear.
Learn more
Safety and rights of clinical study participants
Taking part in a clinical study is voluntary: you may withdraw at any stage. The study undergoes ethics review, participation is impossible without an insurance contract, and under the GCP Rules the rights, safety and well-being of participants outweigh the interests of science.
Learn more
Who can become a volunteer in a clinical study
There is no single list: the conditions of participation are set by the protocol of each study, and the investigator physician decides. Bioequivalence studies use healthy volunteers aged 18 or over; the law bars several groups, for example pregnant and breastfeeding women.
Learn more