This document provides quality control requirements and other requirements for the clinical research process of chimeric antigen receptor T cell products. This document applies to the quality control, monitoring and auditing of clinical studies of chimeric antigen receptor T cell products conducted by clinical trials/research institutions, sponsors, monitoring and auditing agencies, including registered clinical trials of chimeric antigen receptor T cell products. and investigator-initiated exploratory clinical studies.
T/ZSA 95-2021 history
2021T/ZSA 95-2021 Requirements for quality control on chimeric antigen receptor T cell products clinical research