T/CACM 015.1-2017 The standard for developing a randomized controlled clinical research protocol for traditional Chinese medicine

Scope

Main technical content: In recent years, clinical research on traditional Chinese medicine (TCM) has been thriving, and high-quality clinical research results have gradually gained international recognition. To ensure the standardization of protocol reports, some international guidelines have been published, such as the SPIRIT (Standard Protocol Items Recommendations for Interventional Trials) guidelines. However, there is still a lack of protocol design standards tailored to the unique characteristics of TCM. Therefore, establishing TCM clinical research protocol design standards can help ensure the scientificity and feasibility of the top-level design of clinical research protocols, better reflect the characteristics of TCM, and ultimately provide patients with more high-level evidence-based medical evidence for clinical decision-making. This standard is based on the Good Clinical Practice (GCP) and corresponding guidelines for clinical trials, combined with the unique characteristics of TCM, to establish normative standards for research protocol development. It includes a total of 28 items and can provide scientific and standardized technical guidance for personnel and institutions needing to develop randomized controlled trial protocols for TCM.

Development Information

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