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New requests or changes to existing terminology can be accessed through the NCI/EVS New Term Request Page and is available for direct download on this page.As of 30 June 2017 the SDTM, SEND and Protocol Controlled Terminology files have been updated on the NCI-EVS Ftp site. These terminology files replace all older SDTM, SEND and Protocol files and include terms from Review Package 30.Identified quality issues can be tracked down to a cell and are reported according to severity classification.One glance at the statistics section is enough to assess check results: Detailed statistics include the results of standard and user checks per domain as well as check summaries.
This also means that, as the rule is at the same time the implementation, there is no room for different interpretations.
The following process shows how the raw data is converted to SDTM standard datasets: Specifications are developed for converting raw data into SDTM datasets as per the SDTM IG 3.1.2 standard.
These specifications should be clear on how all domains fall into different classes described in the SDTM Implementation Guide.
Intra-domain, cross-domain and cross-model checks are executed for SDTM/ADa M as far as possible from the very first available domain thus supporting prompt QC.
Results of additional checks are included in the main check report.