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dnaSRPS CEN ISO/TS 5499:2023

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

General information

50.60     Dec 4, 2023

ISS

I215

Technical Specification

35.240.80  

English  

Scope

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

Life cycle

NOW

PROJECT
dnaSRPS CEN ISO/TS 5499:2023
50.60 Close of voting. Proof returned by secretariat
Dec 4, 2023

Related project

Adopted from CEN ISO/TS 5499:2024

Adopted from ISO/TS 5499:2024 IDENTICAL