This document stipulates the technical specifications for ethical review of data collection, transfer, storage, utilization, and publication of real-world data for clinical research. This document is intended for use by personnel from drug approval agencies, medical institutions, businesses, and research institutions when reviewing relevant types of studies.
T/CACM 1371.4-2021 history
2021T/CACM 1371.4-2021 Technical specifications for real-world studies of traditional Chinese medicine - Ethical review