T/CACM 1323-2019 in English

本标准规定了中医药临床研究开展数据监查委员会工作的一般原则和技术方法。
本标准适用于中药新药临床试验和各类需要建立数据监查委员会的中医药临床研究等。

Scope

Clinical data monitoring in clinical research is a continuous process conducted by an independent expert group outside of the clinical study organizers, sponsors/initiators, and investigators. It monitors various risks including the safety of participants and reviews and evaluates technical processes for assessing cumulative safety or efficacy data to protect participant safety and ensure the scientific integrity of clinical studies. This has become an essential component in large-scale, multi-center, high-risk clinical research internationally. However, the establishment of a clinical trial data monitoring system in domestic clinical research has not been widely promoted.

Since the beginning of the 21st century, with the increasing number of traditional Chinese medicine (TCM) clinical studies, TCM clinical research is gradually shifting from traditional experiential summation to seeking evidence-based medicine. In this process, a series of operational norms are urgently needed to continuously improve the methodology of TCM clinical research. Additionally, due to the complex composition of herbal ingredients leading to diverse and low-intensity effects, measurement biases frequently occur in TCM clinical studies. Ensuring data accuracy and completeness, enhancing the quality and level of TCM clinical research, is a pressing and challenging issue. Introducing internationally recognized comprehensive, full-process, and tracking dynamic clinical trial data monitoring methods into TCM clinical research and promoting their widespread application will be significant for establishing a complete system of quality control and assurance in TCM clinical research, improving the quality of such studies, and enabling them to reach international standards sooner.

This guideline is based on relevant Chinese laws, regulations, and management systems. It refers to international norms, technical requirements, and methods used by clinical trial data monitoring committees, taking into account the characteristics and current state of TCM clinical research. The aim is to propose technical requirements and guidelines for establishing a TCM clinical trial data monitoring committee, guiding the standardized work of such committees in TCM clinical studies, and playing an active role in improving the overall quality and level of domestic TCM clinical research.