T/CACM 1323-2019 The technical specifications for monitoring clinical research data in traditional Chinese medicine

Scope

Main technical content: Clinical research data monitoring is an ongoing process conducted by an expert group independent of clinical research organizers, sponsors/initiators, and researchers, aimed at continuously monitoring various risks including subject safety and reviewing the technical process of evaluating cumulative data on safety or efficacy. It is a crucial measure to protect subject safety and ensure the scientific integrity of clinical research, and has become an indispensable component of large-scale, multi-center, high-risk clinical research worldwide. However, the establishment of a clinical research data monitoring system in domestic clinical research has not been widely promoted yet. Since the 21st century, with the increasing number of TCM clinical research projects, TCM clinical research is gradually shifting from traditional empirical summaries to seeking evidence-based medical evidence. In this process, there is an urgent need to establish a series of operational guidelines to continuously improve the methodology of TCM clinical research. At the same time, the complex composition of TCM ingredients results in clinical efficacy often manifesting as "multiple target effects and low effect intensity", leading to significant measurement bias in TCM clinical research. How to ensure the accuracy and completeness of data and improve the quality and level of TCM clinical research is an urgent focus and challenge in TCM clinical research. Introducing internationally recognized full-process, full-coverage, and full-tracking dynamic clinical research data monitoring methods into TCM clinical research and promoting their widespread application will be of landmark significance for establishing a complete quality control and assurance system for TCM clinical research, improving the quality of TCM clinical research, and enabling it to reach international standards as soon as possible. This guideline is based on current relevant laws, regulations, and management

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