DANSK DS/CEN ISO/TS 5499 PDF

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