Fraud and misconduct in clinical research
Joanna Polanin-Huk 1  
Jacek Huk 2,  
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Clinical Research Organization – Worldwide Clinical Trials, Warsaw, Poland
Department of Gastroenterology, Provincial Hospital No. 2, Rzeszow, Poland
Faculty of Human Nutrition and Consumer Sciences, Warsaw University of Life Sciences; Department of Endoscopy, Institute of Rural Health, Lublin, Poland
JPCCR 2010;4(2):158–160
The clinical research industry is one of the most heavily regulated industries that exists. One cannot function in this industry in a compliant manner without knowing the regulations and the responsibilities they are expected to maintain. Good Clinical Practice (GCP) is a set of guidelines for the design, performance, monitoring, recording, analysis, and reporting of clinical trials. Only by maintaining such policy can fraud and misconduct in biomedical research be minimised, and it is manifestly in the interest of patients and healthy volunteers who participate in research projects. These guidelines are recognized as overall standard operating procedures in conducting clinical research. Compliance with GCP standards ensures the proper and ethical conduct of trials while preventing, or at least reducing, the chances of misconduct and fraud. This is why it is crucial for all research professionals to understand and to be familiar with GCP. In essence, GCP can be viewed as a system of shared responsibilities between sponsors, clinical investigators, Institutional Review Boards, and the Food and Drug Administration (FDA), all working together to preserve the integrity of clinical research. When questionable accuracy or fraud infects a trial, the affects become contagious.
Joanna Polanin-Huk   
Clinical Research Organization – Worldwide Clinical Trials, Jana Pawła II 23, 00-854 Warsaw, Poland.
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