ISO/TS 5499:2024 Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers, 2024

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ISO

ISO/TS 5499:2024 Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers

Edition: 2024

$386.77
/ user per year

Description
About ISO

Content Description

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

About ISO

ISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better.

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