Med. praxi. 2014;11(1):44-46

Audit in clinical trials

MUDr.Anetta Jedličková
Fakulta humanitních studií, Univerzita Karlova v Praze

In the article are described audits in clinical trials and their organization. The author points out misconduct/fraud as a serious problem

in medical research. The article contains two case reports related to fraud in clinical trials.

Keywords: clinical trials, audits in clinical trials, misconduct/fraud in clinical trials, medical ethics

Published: February 1, 2014  Show citation

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Jedličková A. Audit in clinical trials. Med. praxi. 2014;11(1):44-46.
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    References

    1. Haškovcová H. Lékařská etika, 3. rozš. vyd., Praha, Galén, 2002.
    2. Haškovcová H. Informovaný souhlas Proč a jak? Praha, Galén, 2007.
    3. Kopečná E, Paseka J, Jedličková A. Monitorace, audit a inspekce v klinickém hodnocení, Praha, Galén, 2009.
    4. Vyhláška 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků. [online]. [cit. 2013-04-18]. Dostupné z: www.mvcr.cz/soubor/ sb072-08-pdf.aspx.

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