Frequently Asked Questions (FAQ) About Clinical Trials
Do you have concerns about participating in a clinical trial? Below you will find answers to the questions most frequently asked by patients.
Safety and Participant Rights
Key topics: safety, informed consent, withdrawal, data protection and oversight.
Yes. Participant safety is the highest priority. Before a clinical trial can begin, both the study protocol and the informed consent form must be approved by an Ethics Committee and the appropriate regulatory authorities. Throughout the study, participants are cared for by qualified healthcare professionals, and all adverse events are monitored and reported.
Clinical trials are subject to strict oversight. This includes review by an Ethics Committee and authorisation by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). In addition, studies may be inspected and audited to ensure compliance with Good Clinical Practice (GCP) standards.
Yes. Participants may withdraw from a clinical trial at any time, without providing a reason and without any negative consequences for their future medical care.
Before joining a study, participants receive detailed information about its purpose, procedures, potential benefits, risks and available alternative treatments. Only after understanding this information and having the opportunity to ask questions can a participant decide whether to sign the informed consent form.
Yes. Participants’ personal data are treated as confidential. Study records and data are stored securely and handled in accordance with applicable regulations and data protection standards.
Costs and Participation Requirements
Common questions about costs, eligibility and participant responsibilities.
Yes. Participation in a clinical trial is free of charge. Costs associated with study visits, laboratory and imaging tests, and the investigational treatment or technology are covered by the study sponsor, as specified in the protocol.
Under Polish law and Good Clinical Practice principles, participants generally do not receive payment for participation in clinical trials. An exception may apply to healthy volunteers participating in Phase I studies.
Eligibility criteria are defined in the study protocol. Participants must meet specific inclusion criteria (such as age, sex or health status) and must not meet exclusion criteria. The investigator determines eligibility based on participant safety and the objectives of the study.
Responsibilities depend on the study protocol but typically include attending scheduled visits, following study instructions, taking medications as directed, completing study diaries and reporting any side effects or health changes.
Benefits, Risks and Study Procedures
Potential benefits, possible risks and what to expect during a clinical trial.
Participation may provide access to innovative treatments or diagnostic methods, enhanced medical monitoring and additional healthcare support. Many participants also value the opportunity to contribute to the advancement of medical knowledge.
Yes. Clinical trials may involve side effects, including some that have not been previously observed. Before signing informed consent, participants are informed about known risks, and all adverse events are carefully monitored and reported throughout the study.
Not always. Clinical trials may evaluate medicines, medical devices, diagnostic methods or other healthcare interventions. Some studies compare a new treatment with the current standard of care or with a placebo, depending on the study design and objectives.