A test person is a participant in a clinical study. The test persons are usually healthy or suffering from a specific disease or symptoms and are selected according to certain defined inclusion and exclusion criteria (e.g. men over 50 years of age with insomnia).
Test person
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Participation in a clinical trial is voluntary. Before participating in a study, the test person must be given detailed written and oral information and must have sufficient time to think about participating in the study. Only when the volunteer has signed the consent form may the study begin. The volunteer may withdraw consent to participate in the study at any time without negative consequences.
The type of clinical trial can vary greatly. The test can take the form of an interview, medical examination, medical measurement or an experiment.
A test person has comprehensive rights, which are regulated e.g. in GCP (Good Clinical Practise). All his data are subject to data protection and may only be recorded and evaluated in anonymised or pseudonymised form. The name and all personal characteristics of the patient must always be treated as strictly confidential. Before the start of the clinical trial, the clinical trial must be approved by an ethics committee. In addition to data protection, the ethical acceptance and health safety must be proven. Before a drug can be administered to test persons, a number of pre-clinical tests must be carried out on animals, bacteria or cell cultures in order to minimise the risk to humans.
In the case of interventional studies, i.e. studies in which an intervention (e.g. taking medication) takes place, a proband insurance policy is taken out - depending on the type of study. The insurance cover usually covers 500,000 euros and applies to damages caused by the study and also includes travel insurance for travel to and from the study centres (clinics). The sponsor is not obliged to take out insurance for cosmetic studies. In addition, participation in the study may be compensated with an expense allowance for each participant.