This Work Package is co-led by ICH and IHTSDO who have responsibility for the MedDRA MSSO and SNOMED terminologies respectively.
Responsibilities of this Work Package include the development of governance document(s), a financial sustainment model, and a terminology mapping maintenance model. These documents will describe the roles and responsibilities of the maintenance organisations, the overall process for developing and maintaining the mappings, and the resources needed to operate the maintenance and development of these mappings.
Work Package 4 will create a software tool list that defines the list of tools needed by the maintenance organisations (IHTSDO and ICH) to develop, maintain, and distribute the mappings. This work stream will also develop the licensing arrangements from the participating terminologies and a draft of the end user agreement (if applicable).
Delivery and quality assurance of the mapping of a subset of terms from each terminology will be undertaken to test the methodologies developed, and enable initial integrations.
The above tasks are critical to develop a sustainable process to develop and maintain mappings between these terminologies. It should be noted that WEB-RADR 2 will not attempt to complete a ‘full map’ of each terminology (SNOMED and MedDRA MSSO), but only the relevant terms for pharmacovigilance.
- CSL Behring