T/CRHA 004-2022 Active

Scope: This document specifies the basic principles of informed consent and donor screening, preparation work, implementation, notification, and file management requirements for the storage of single nucleated cell resources from peripheral blood donated by healthy blood donors. This document applies to the informed consent and donor screening for the storage of single nucleated cell resources from healthy donors in public banks. It does not apply to the donor screening of blood samples used for clinical diagnosis. Main technical content: The main technical content of this standard is the basic principles of informed consent and donor screening, preparation work, implementation, notification, and file management requirements for the storage of single nucleated cell resources from peripheral blood donated by healthy blood donors. The overall structure adopted is as follows: 1) Scope 2) Normative reference documents 3) Terms and definitions 4) Basic principles 5) Preparation work 6) Implementation 7) Notification 8) File management