Argument (#10 October 2013)

Investigators’ Legal Status in Entering Clinical Trial Services Agreements

Lana V. Sinichkina, Igor P. Svitlyk

According to practice established in Ukraine, investigators are contracted in two capacities: as private entrepreneurs and as individuals. However, due to the lack of clarity of the legislation, а question often asked lately by the community involved in clinical trials for medicines can individuals entering into clinical trial services agreements with non-resident sponsors or contract research organizations (CRO) can enter into such relations without becoming entrepreneurs…

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