Work Package 4 – Terminology Mapping And Maintenance

Work Package 4 is co-led by ICH and SNOMED International who have responsibility for the MedDRA and SNOMED CT terminologies respectively.

The goals of Work Package 4 are to produce initial bi-directional mappings between SNOMED CT and MedDRA and put in place processes to maintain these two maps. The maintenance process is key to sustaining the maps after the WEB-RADR 2 project ends. The Work Package will also draft the necessary agreements between ICH and SNOMED International to describe the roles and responsibilities of the two organisations to maintain, distribute, and support these maps and to manage any changes in SNOMED CT and MedDRA that impact on either map.

The project has developed a methodology, including coding conventions and quality assurance processes, which have been tested on a subset of terms agreed to be in scope of the work. Work is now progressing to complete the mapping work to an agreed schedule in line with WEB RADR 2 project timelines. In addition, Work Package 4 will produce documentation for users, including use cases, the mapping conventions applied, maintenance/release notes, and relevant history information.

It should be noted that the WEB-RADR 2 project work does not cover a complete map between the  two terminology (SNOMED CT and MedDRA), but an agreed set of frequently used pharmacovigilance terms. SNOMED International and ICH have committed to the maintenance of the two maps after the WEB-RADR 2 project ends.

Partners involved:

  • MHRA
  • Novartis
  • AbbVie
  • SNOMED International
  • CSL Behring
  • ICH
  • Pfizer