ISO/TS 5499:2024 保健信息学 临床细节 治疗适应症术语和标识符的协调核心原则

标准编号：ISO/TS 5499:2024

中文名称：保健信息学 临床细节 治疗适应症术语和标识符的协调核心原则

英文名称：Health informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers

发布日期：2024-01

标准范围

本文件的目的是为创建、评估、选择和维护用于描述和编码研究和药品、医疗器械、组合产品、生物制剂和伴随诊断的IDMP治疗适应症的术语资源之间的映射建立通用原则。还讨论了核心维护原则，如未来指示术语使用的地图的可靠性、再现性和质量保证。本文档的目标受众包括:A）？参与医药产品开发、授权和营销的全球监管机构、制药/生物制药公司、临床研究组织（CRO）和大学/科研机构b）？IDMP实施者寻求有关治疗适应症编码的更多信息c）？医疗服务提供者d）？标准组织e）？开发和实施术语映射集的实施者和软件供应商(f)？患者

The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes:

a)       Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products

b)       Implementers of IDMP seeking more information about coding of Therapeutic Indications

c)        Healthcare providers

d)       Standards Organizations

e)       Implementers and software vendors developing and implementing terminology map sets

f)         Patients

标准预览图