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 2024-09-27 CDISC-6037 Add C209537 Term DICTNAM Dictionary Name Add new term to existing codelist - - - ISO 3166 2024-09-27 CDISC-6037 Add C81895 Term DICTNAM Dictionary Name Add new term to existing codelist - - - ISO 21090 2024-09-27 CDISC-6532 Update C53489 CDISC Definition DICTNAM Dictionary Name Update CDISC Definition A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) A structured nomenclature and classification of the terminology used in human and veterinary medicine developed by the College of Pathologists and American Veterinary Medical Association. (CDISC Glossary) 2024-09-27 CDISC-6532 Update C66788 CDISC Definition DICTNAM Dictionary Name Update CDISC Definition A name given to a reference source that lists words and gives their meaning. (NCI) Terminology relevant to the names given to a reference source that lists words and gives their meaning. 2024-09-27 CDISC-6408 Update C103374 CDISC Definition GNRLOBSC General Observation Class Update CDISC Definition This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). This SDTM class captures investigational, therapeutic and other products that are administered to the subject either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). 2024-09-27 CDISC-6532 Update C103377 CDISC Definition GNRLOBSC General Observation Class Update CDISC Definition This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE, SJ, SM and SV. 2024-09-27 CDISC-6532 Update C25936 CDISC Definition ORIGINS Origin Source Update CDISC Definition A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at the trial site, the investigator is the responsible leader of the team and may be called the principal investigator. A person responsible for the conduct of the study, ensuring adherence to the protocol and good clinical practices. (CDISC Glossary) 2024-09-27 CDISC-6438 Update C170550 CDISC Definition ORIGINT Origin Type Update CDISC Definition A value that is copied from a variable in another dataset. A value that is copied from another variable. 2024-09-27 CDISC-5794 Update C160924 CDISC Definition SDTMIGRS SDTMIG Version Response Update CDISC Definition Terminology relevant to the version of the study data tabulation model implementation guide used in the study. A terminology codelist relevant to the version of the CDISC Study Data Tabulation Model implementation guide that is being used in the study submission.