Good Clinical Practice (GCP) – a set of internationally recognized guidelines that must be followed when planning, conducting, managing, monitoring, auditing, and analyzing a clinical trial, as well as when processing and reporting its results.

Principal Investigator – an KVUH employee who possesses the appropriate qualifications and has been authorized by KVUH and the sponsor to conduct the clinical trial. The Principal Investigator is responsible for ensuring that the activities conducted as part of the clinical trial comply with the study protocol, for the members of the study team, and for the health of the trial participants.

Study team – a group of FNKV employees who possess the appropriate qualifications and have been authorized by the principal investigator to perform specific tasks during a clinical trial, such as co-investigators, clinical trial coordinators, study nurses, pharmacists, and laboratory technicians.

Trial participant – a person participating in a clinical trial. This may be a healthy volunteer (in bioequivalence studies, vaccine studies, or pharmacokinetic studies) or an FNKV patient who has signed an informed consent form (or whose legal representative has signed it) and has been enrolled in the clinical trial.

Informed consent – the patient’s free and well-considered consent given on the basis of complete and understandable information provided about the clinical trial. By signing the informed consent form, the patient confirms that they have been informed about the course of the clinical trial, its purpose, the possible risks of treatment, the obligations associated with participation, and other requirements of the clinical trial. Signing the informed consent form is a prerequisite for the patient’s enrollment in the clinical trial.

Ethics Committee – an independent body composed of healthcare professionals and individuals without a medical background. The committee’s primary responsibility is to protect the rights, safety, and health of participants in clinical trials.

SÚKL (State Institute for Drug Control) – The administrative authority of the Czech Republic responsible for the supervision of medicinal products and medical devices, including their registration, quality control, safety, and oversight of clinical trials.
The assessment focuses primarily on the risk-benefit ratio, i.e., the potential risk to patients versus the potential benefit of the study (not only for individuals but for the entire population), an evaluation of the study design (i.e., patient selection, visit schedule, chosen controls and examinations, dosage and duration of treatment, defined objectives, and selection of parameters to demonstrate them), on the basis of which it is possible to obtain objective and valid results from the study, and, last but not least, an assessment of the quality of the drugs used.

Clinical trial sponsor (sponsor) – a legal entity or individual who assumes responsibility for initiating, conducting, and funding a clinical trial. Most often, these are pharmaceutical companies seeking to bring a new drug to market.

Protocol – a document that describes the objective(s), plan, methodology, statistical analysis, and structure of the study. The protocol specifies which examinations will be performed during each study visit, as well as when and how the drug or medical device will be administered. Good cooperation between the study subject (patient) and the study team is essential for the successful conduct of the clinical trial and the subsequent use of its results.