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National Repository of Grey Literature

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The Ethics of the Clinical research from the perspective of a Clinical research associate Norková, Olga ; Haškovcová, Helena (advisor) ; Rohanová, Eva (referee) Monitoring is one of the most important methods of overseeing the pursuit of the clinical research. A monitoring person (Clinical research associate) is responsible for verifying correctness of the monitoring process in the trial site and checks that the respect for dignity and rights of individual subjects exposed to the clinical research are being abided by. The theoretical part of the MA thesis examines the issue of the clinical research of medicinal products and explains the basic terminology pertaining to the performance of the clinical research. The thesis further analyses the position of Clinical research associate and describes the monitoring process. Concurrently, the ethical problems, which Clinical research associate encounters in practice, are traced. The empirical section studies the outcomes of an investigation conducted via a questionnaire, which focused on how Clinical research associate perceive the ethical problems. As a result, the study identifies the most frequently observed ethical issues. Respondents of the questionnaire view the ethical issues as less significant. Clinical research associates are not united in tagging the most frequent occurrence of ethical problems (in the field of medicine and the catchment area). In the same section, the MA thesis rebuts a hypothesis... Detailed record

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