On the issue of the subject of Clinical Study Agreement

Abstract

   The primary thing in establishing relations based on any civil law transaction is to come to an agreement that constitutes the mutual agreement of the will of the parties. With the growing number of ongoing clinical trials, it is important to consider in detail the key terms of the agreement concluded with the contractor and the organizer of the study, as an initial fact that affects the conditions for the emergence of other relationships affecting a significant number of citizens who subsequently participate in this study. A detailed study of the subject matter of the contract for conducting a clinical trial of a medicinal product for medical use is relevant to increase the effectiveness of ongoing research, ensure legal certainty and compliance with ethical standards. This paper highlights the main civil approaches that have developed regarding the defi nition of the subject of a civil law contract in general and a contract for conducting a clinical trial in particular, and describes the problem of uncertainty in the establishment and approval of this essential condition. The author attempts to identify a set of specific parameters included in the subject, allowing us to talk about the conclusion of the transaction, and concludes that the complex nature of the condition under consideration includes, for the parties to have rights and obligations, the need to coordinate the design of the study, the name of the medicinal product as an object of research, the purpose of the study and the obtained result.