https://doi.org/10.21697/zp.2022.22.1.07
This article discusses clinical trial agreements for medicinal products and medical devices. It presents the most important aspects of such agreements, specifies the legislation applicable in Poland, describes their subject and the parties concerned, defines the form in which they should be concluded, indicates the most important items in their content, and tries to classify them according to the criteria adopted in Polish civil law. In view of the important role agreements for clinical trials play in comparison to the imprecise legal regulations, I present a detailed account of the specific features of such agreements. A well written contract can help to enhance the safety of participants in a clinical trial, as well as of the patients who will be using the tested products once they have been validated for therapeutic use.
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