In clinical trials, the most important thing is the safety of the clinical trial participant and ensuring his or her rights, which is why all research must be conducted in accordance with Good Clinical Practice guidelines.
RIGHTS OF A CLINICAL TRIAL PARTICIPANT
- Participation in a clinical trial is completely voluntary.
- A clinical trial participant has the right to resign from participating in a clinical trial at any time without suffering any consequences. In the event of refusal to participate in the study, the study participant does not lose his or her rights to treatment considered standard and appropriate in his or her case.
- The clinical trial participant is provided with sufficient time to carefully read the written information about the trial and the informed consent form to participate in the trial.
- The decision to participate in a clinical trial must be fully informed. If, after reading the prepared materials, they are incomprehensible to the clinical trial participant, he or she has the opportunity to ask questions and receive comprehensive answers.
- A clinical trial participant has the right to obtain information about his or her health from the doctor conducting the trial (researcher) at every stage of the clinical trial and to access the documentation relating to him or her.
- A clinical trial participant has the right to information about any new data that may influence his or her decision regarding further participation in the trial. For example, you may receive new information about the risks of using the investigational product.
- A clinical trial participant is entitled to compensation if he or she suffered permanent health damage directly related to the investigational product used or the medical procedure required by the trial protocol in accordance with the principles set out in the Regulation of the Minister of Finance of December 2, 2022 (Journal of Laws 2022.2563).
- Participation in the clinical trial is free of charge for the participant. The costs of investigational products, specialized tests and medical care are borne by the study sponsor.
- A clinical trial participant has the right to full anonymity and protection of his or her personal data.
RESPONSIBILITIES OF A CLINICAL TRIAL PARTICIPANT:
- The clinical trial participant undertakes to follow the recommendations of the doctors conducting the trial (researchers).
- The clinical trial participant is obliged to follow the visit schedule. If planning to change or cancel a scheduled visit, the patient should inform the Investigator in advance.
- By consenting to participate in a clinical trial, the study participant agrees to make medical records available to the research team, representatives of the Sponsor/company conducting the study on behalf of the Sponsor, and inspectors/auditors.
- The study participant is obliged to inform the researcher about past and present diseases, as well as the treatment used.
- Both during and after the study, the clinical trial participant should report any observed changes in his or her health to the Investigator.
- The clinical trial participant is obliged to take the investigational product in accordance with the instructions provided by the Investigator.
- A clinical trial participant may not participate in more than one clinical trial at the same time.
WHY IT IS WORTH PARTICIPATING IN A CLINICAL TRIAL
- A person participating in a clinical trial is under the constant care of a qualified team of specialists.
- The clinical trial participant has access to the most modern diagnostic methods.
- A clinical trial participant contributes to the development of medicine.
- Possibility of reimbursement of travel costs for examinations.
Ethical standards and legal acts regarding conducting clinical trials are available on the website: Patient in clinical trials
If you have any questions, please contact us: badaniakliniczne@ginemedica.pl