GB/T 42465-2023Basic dataset of biological material information in traditional Chinese medicine (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part

1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed and coordinated by the National Technical Committee for Standardization of Biological Samples (SAC/TC559). This document was drafted by: Guangdong Provincial Hospital of Traditional Chinese Medicine (The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine), Shanghai Xinchao Biotechnology Co., Ltd., Shanghai Hai Biochip Co., Ltd., Institute of Traditional Chinese Medicine Information, China Academy of Chinese Medical Sciences, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Beijing Traditional Chinese Medicine University Dongzhimen Hospital, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Hubei Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Tianjin Traditional Chinese Medicine The First Affiliated Hospital of Medical University. The main drafters of this document. Li Hui, Chen Qubo, Lu Chuanjian, Gao Hengjun, Zhang Xiaoyan, Xie Xiuli, Xie Runsheng, Zeng Xuan, Li Haiyan, Zhao Yongfang, Liu Weijing, Liang Yan, Li Xiaodong, Xie Xiaobing, Fan Guanwei.

The construction of human biological sample banks increasingly shows the development trend of systematic resource management, standardization of technical specifications, and informatization of shared services. The field of traditional Chinese medicine has extensively carried out the construction and research of human biological sample banks. In order to meet the business processing, scientific research, and information related to traditional Chinese medicine Information sharing and other needs, this document is designed according to the concept of data set and integrates the basic information of traditional Chinese medicine used to manage and identify human biological samples. gather. This document can provide basic data set specifications for traditional Chinese medicine institutions that collect, store, and use human biological samples to meet the needs of data exchange and sharing. demand and promote the modernization and industrialization development of traditional Chinese medicine. Basic data set of traditional Chinese medicine information on human biological samples

1 Scope

China's national basic dataset for biological material information in traditional Chinese medicine. It specifies the data elements that must be recorded about a medicinal biological material. The problem it addresses is that traditional Chinese medicine draws on thousands of plant, animal and fungal materials, many of which are known by names that vary regionally, that cover more than one botanical species, and whose identity has drifted over centuries of use. That ambiguity has consequences: the wrong species substituted for another has caused serious poisonings, adulteration is commercially attractive and hard to detect, and endangered species have entered the trade under trade names that concealed their origin. A structured dataset - species identity, origin, part used, harvest, processing, and increasingly the DNA barcode - is what allows a material to be traced and verified, and it is the precondition for the industry being regulated as a pharmaceutical one.

This document specifies the basic data set of traditional Chinese medicine information on human biological samples, including metadata, data element attributes and codes. This document applies to the identification, collection, storage and sharing of traditional Chinese medicine information on human biological samples.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document.

GB/T 15657 Traditional Chinese Medicine Disease and Syndrome Classification and Codes

GB/T 16751.1 Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine Part

3 Terms and definitions

The following terms and definitions as defined in GB/T 18391.1, GB/T 37864 and WS370 apply to this document.

3.1 biological samplebiologicalmaterial Obtained or derived from biological entities such as humans, animals, plants, microorganisms, or non-animal/plant multicellular organisms (such as brown seaweed and fungi). Any living substance. [Source: GB/T 37864-2019,3.7]

3.2 basicdatasetbasicdataset Under a specific theme, in order to meet the needs of standardized construction of business information systems and data exchange and sharing within and between fields, the design A collection of minimum data elements contained in each subsystem (or functional module) summarized by the design. [Source: WS370-2012,3.1]

4 Incisional diagnosis

WS363.1-2011 Health information data metacatalog Part