ГлавнаяDocumentsMedical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 7 Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials - Article 41. Contract for Clinical Trial of Medicinal Product for Medical Use
Article 41. Contract for Clinical Trial of Medicinal Product for Medical Use
1. A clinical trial of a medicinal product for medical use shall be conducted in accordance with the contract for the clinical trial of the medicinal product for medical use to be concluded between the institution which obtained a permit from the authorized federal executive body for organization of such trial and medical institution conducting the clinical trial of the medicinal product.
2. A contract for a clinical trial of a medicinal product for medical use shall:
1) prescribe trial terms and conditions, 2) determine the total cost of the trial program indicating the amount to be paid to the investigators and co-investigators; and 3) determine the form in which the trail results are to be presented to the authorized federal executive body.