Encyclopedia

Clinical Study Protocol for a Biomedical Cellular Product


Clinical trial protocol for a biomedicinal cellular product — a document defining the objectives of the clinical trial of a biomedicinal cellular product, its forms of organization and methodology, statistical methods for processing the results of the study, and measures to ensure the safety of patients participating in the clinical trial of a biomedicinal cellular product1;

  1. Federal Law No. 180-FZ dated June 23, 2016 "On Biomedicinal Cellular Products". 2016, as amended on January 1, 2017, Article 2, paragraph 16. ↩

Laws with commentary

Codes and federal laws