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-5899 Update C25212 CDISC Definition DDF Entity Terminology DDF Entity Terminology Update CDISC Definition A defined variable intended to reflect an outcome measure of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) A defined variable intended to reflect an outcome of interest that is statistically analyzed to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. [After BEST Resource] (CDISC Glossary) 2022-12-16 CDISC-5899 Update C25218 CDISC Definition DDF Entity Terminology DDF Entity Terminology Update CDISC Definition The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study. [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] (CDISC-Glossary) The drug, device, therapy, or process under investigation in a clinical study that is believed to have an effect on outcomes of interest in a study (e.g., health-related quality of life, efficacy, safety, pharmacoeconomics). [After https://grants.nih.gov/grants/policy/faq_clinical_trial_definition.htm#5224] 2022-12-16 CDISC-5899 Update C70793 CDISC Definition Organization Type Value Set Terminology Organization Type Value Set Terminology 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]