Standard Technical specification · SIS-CEN ISO/TS 5499:2024

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

Status: Valid

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Standard Technical specification · SIS-CEN ISO/TS 5499:2024

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

Subjects

IT applications in health care technology (35.240.80)


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Standard Technical specification · SIS-CEN ISO/TS 5499:2024

Health informatics — Clinical particulars — Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024, IDT)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-82085467

Edition: 1

Approved: 3/5/2024

No of pages: 33