Release Date Request Code Change Type NCI Code CDISC Term Type CDISC Codelist (Short Name) CDISC Codelist (Long Name) Change Summary Original New Change Implementation Instructions 2022-12-16 CDISC-5132 Add C160924 CDISC Codelist SDTMIGRS SDTMIG Version Response Addition of new codelist - - - SDTMIGRS 2022-12-16 CDISC-5132 Add C161432 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.1.1 2022-12-16 CDISC-5132 Add C161433 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.1.2 2022-12-16 CDISC-5132 Add C161434 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - Version 3.1.2 Amendment 1 2022-12-16 CDISC-5132 Add C161435 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.1.3 2022-12-16 CDISC-5132 Add C161436 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.2 2022-12-16 CDISC-5132 Add C161437 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.3 2022-12-16 CDISC-5132 Add C189638 Term SDTMIGRS SDTMIG Version Response Add new term to new codelist - - - 3.4 2022-12-16 CDISC-5653 Add C191213 Term STDNAM Standard Name Add new term to existing codelist - - - BIMO 2022-12-16 CDISC-5899 Update C49704 CDISC Definition DICTNAM Dictionary Name Update CDISC Definition A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. 2022-12-16 CDISC-5899 Update C70793 CDISC Definition ORIGINS Origin Source Update CDISC Definition An entity that is responsible for the initiation, management, and/or financing of a clinical study. An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP]