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  • Basic Terms

    Basic Terms - Czech Republic

    Ethics Committee
    An independent committee consisting of health and scientific professionals and non-scientific members which investigates whether the rights and health of patients are protected and their safety is ensured. It approves the documents according to which the clinical study is performed.

    Informed consent
    Process in which a potential study participant gains information and is instructed about the specific clinical study. One integral part of this process is a document where the relevant person signs to confirm that he or she agrees with participation.

    Evaluated medicine
    Tested medicine or placebo used in the clinical study.

    Identification code of trial subjects
    Prevents discovery of the identity of a patient during the processing of the acquired data.

    Monitoring
    Regular monitoring of course of clinical study.

    Placebo
    Inactive substance given to trial subjects in many studies and allowing comparison of efficacy. Its administration may result in a so-called placebo effect.

    Placebo effect
    Phenomenon where the use of an inactive substance (placebo) displays a positive impact on the health of a patient. This phenomenon is caused by the positive expectations of the patient concerning the results of treatment.

    Protocol
    Document which describes in detail how the clinical study will be conducted.

    Randomisation
    Process during which the patients are randomly allocated to a treatment group (using the test medicine) or a control group (using a placebo or comparator).

    Good Clinical Practice (GCP)
    Internationally acknowledged set of rules according to which all clinical studies are performed. These rules ensure that the data from the clinical studies is credible, and that the rights and health of trial subjects are protected.

    Comparator
    An already used medicine (or placebo) which is compared with the test medicine.

    Trial subject
    Person who participates in a clinical study (patient).

    Sponsor
    Person or organisation which is responsible for conducting and financing the clinical study.

    Blinding
    Procedure where one or several parties is not informed about inclusion in a treatment group. In the case of "single” blinding, patients are not informed, and in the case of “double” blinding, neither the patients nor medical personnel are informed.

    Investigator
    Doctor responsible for treatment and monitoring of study participants in the given medical facility.