CDISC Controlled Terminology SDTM - 2011-06-10 CDISC NCI Submission Codelist Code Value Codelist Name CDISC Definition Extensible C66767 ACN Action Taken with Study Action Taken with Study Treatment No Treatment C66769 AESEV Severity/Intensity Scale A scale that defines the degree or state of disease existing in a patient as a result of the No for Adverse Events occurrence of an adverse event. (NCI) C66780 AGESPAN Age Span Subgroups of populations based on age. (NCI) Yes C66781 AGEU Age Unit Those units of time that are routinely used to express the age of a person. (NCI) No C66786 COUNTRY Country A collective generic term that refers here to a wide variety of dependencies, areas of No special sovereignty, uninhabited islands, and other entities in addition to the traditional countries or independent states. (NCI) C78731 DATEST Drug Accountability The name of the test for the drug accountability assessment. Yes Test Name C78732 DATESTCD Drug Accountability The short name, or code, of the test for the drug accountability assessment. Yes Test Code C66788 DICTNAM Dictionary Name A name given to a reference source that lists words and gives their meaning. (NCI) Yes C66734 DOMAIN Domain Abbreviation A unique, 2-character domain code used in the regulatory submission process. The domain Yes abbreviation is used consistently throughout the submission, i.e. in the dataset name, as the value of the domain variable within the dataset, and as a prefix for most variable names in the dataset. (CDISC Glossary) C74558 DSCAT Category for Classifications that describe and group pertinent events that occur throughout the conduct Yes Disposition Event of a clinical trial. C90013 EGLEAD ECG Lead Terminology related to electrocardiogram lead names. Yes C71151 EGMETHOD ECG Test Method Terminology codelist used with ECG Test Methods within CDISC. Yes C71150 EGSTRESC ECG Result Terminology codelist used with ECG Findings and Abnormalities within CDISC. Yes C71152 EGTEST ECG Test Name Terminology codelist used with ECG Test Names within CDISC. Yes C71153 EGTESTCD ECG Test Code Terminology codelist used with ECG Tests within CDISC. Yes C66790 ETHNIC Ethnic Group A social group characterized by a distinctive social and cultural tradition maintained from Yes generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease. (NCI) C78735 EVAL Evaluator The role that the individual or entity plays with respect to a specific situation or person. Yes C71113 FREQ Frequency The terminology that includes terms pertaining to frequency within CDISC. Yes C66726 FRM Pharmaceutical Dosage The form of the completed pharmaceutical product, e.g. tablet, capsule, injection, elixir, Yes Form suppository. Dosage form can have a significant effect on the onset, duration and intensity of the pharmacological action of a drug. A pharmaceutical dosage form controls the rate at which the drug is released into the biological fluids. This release rate affects its intrinsic absorption pattern and therefore, the bioavailability of the drug. C66797 IECAT Category for A collection of criteria on which subjects are evaluated and that must be met by all study No Inclusion/Exclusion subjects. (NCI) C67154 LBTEST Laboratory Test Name Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. Yes C65047 LBTESTCD Laboratory Test Code Terminology used for Laboratory Tests of the CDISC Standard Data Tabulation Model. Yes C74456 LOC Anatomical Location Terminology codelist used for anatomical location within CDISC. Yes C76348 MARISTAT Marital Status A demographic parameter indicating a person's current conjugal status. Yes C96777 MEDEVAL Medical Evaluator The individual responsible for the medical assessment. Yes Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2011-06-10 - page 1 of 355 - CDISC Controlled Terminology SDTM - 2011-06-10 CDISC NCI Submission Codelist Code Value Codelist Name CDISC Definition Extensible C85492 METHOD Method Method is any technique or procedure (an action) that determines how an observation or Yes clinical finding was made. C85491 MICROORG Microorganism Microorganisms, bacteria, fungi and other organisms. Yes C85495 MSRESCAT Microbiology Used to categorize the result of a finding in a standard format. No Susceptibility Testing Result Category C78738 NCF Never/Current/Former A classification of usage or experience that falls into three categories; never, current, or Yes Classification former. C66727 NCOMPLT Completion/Reason for The status of the subject's completion of the study or a segment of the study, or the reason Yes Non-Completion the subject discontinued the study or segment of the study. C66789 ND Not Done Indicates a task, process or examination that has either not been initiated or completed. No (NCI) C78736 NRIND Reference Range A description of the results relative to the normal or expected range of values. Yes Indicator C66742 NY No Yes Response A term that is used to indicate a question with permissible values of yes/no/unknown/not No applicable. C66768 OUT Outcome of Event A condition or event that is attributed to the adverse event and is the result or conclusion No of the adverse event. (NCI) C95120 PHSPRP Physical Properties Test Terminology relevant to the test names that describe the physical characteristics of an Yes Name entity. C95121 PHSPRPCD Physical Properties Test Terminology relevant to the test codes that describe the physical characteristics of an Yes Code entity. C85493 PKPARM PK Parameters Parameters used to describe the time-concentration curve. Yes C85839 PKPARMCD PK Parameters Code Parameter codes used to describe the time-concentration curve. Yes C85494 PKUNIT PK Parameter Units of Units of measure needed for pharmacokinetic parameters. Yes Measure C71148 POSITION Position Terminology codelist used with Body Position within CDISC. Yes C74457 RACE Race Terminology codelist used to identify the race of an individual within the Clinical Data Yes Interchange Standards Consortium Study Data Tabulation Model. C78737 RELTYPE Relationship Type The description of relationship types between a record or set of records. No C66729 ROUTE Route of Administration The course by which a substance was administered in order to reach the site of action in Yes the body. C96785 RSSTRESC Tumor Response Result The result of an assessment of tumor response to treatment or therapy. Yes C96781 RSTEST Tumor Response Terminology relevant to the test names that describe an assessment of tumor response to Yes Assessment Test Name treatment or therapy. C96782 RSTESTCD Tumor Response Terminology relevant to the test codes that describe an assessment of tumor response to Yes Assessment Test Code treatment or therapy. C74559 SCCD Subject Characteristic A unique code representing each Subject Characteristic. Yes Code C66731 SEX Sex The assemblage of physical properties or qualities by which male is distinguished from No female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI) C66732 SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject group being studied. (NCI) No C66733 SIZE Size The physical magnitude of something. (NCI) Yes C76351 SKINCLAS Skin Classification A classification system used to categorize the sensitivity of a subject's skin to sunlight. Yes Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2011-06-10 - page 2 of 355 - CDISC Controlled Terminology SDTM - 2011-06-10 CDISC NCI Submission Codelist Code Value Codelist Name CDISC Definition Extensible C74561 SKINTYP Skin Type A distinctive characteristic of the skin marked by the amount of sebum secreted by Yes sebaceous glands. C66783 SOC CDISC System Organ Terms at the highest level of the CDISC system organ class terminology. No Class C78733 SPECCOND Specimen Condition The physical state or quality of a biological specimen. Yes C78734 SPECTYPE Specimen Type The name and description of a biological specimen. Yes C66728 STENRF Relation to Reference The relative relationship of a timepoint to a reference timepoint. No Period C66735 TBLIND Trial Blinding Schema The name of a code list that contains terms to define the type of blinding for the trial. Yes (NCI) C66785 TCNTRL Control Type Comparator against which the study treatment is evaluated (e.g., concurrent (placebo, no Yes treatment, dose-response, active), external (historical, published literature). C66787 TDIGRP Diagnosis Group A grouping of individuals on the basis of a shared procedure or disease, or lack thereof Yes (e.g. healthy volunteers, type 2 diabetic subjects, subjects with renal cell cancer). Standardized naming systems are available that define the groups within which a subject should be placed. (NCI) C66736 TINDTP Trial Indication Type The name of a code list that contains terms to define the type of trial, e.g. cure or Yes prevention. (NCI) C66784 TOXGR Common Terminology A standard terminology developed to report adverse events occurring in cancer clinical No Criteria for Adverse trials. Common terminology criteria for adverse events (CTCAE) are used in study adverse Events event summaries and Investigational New Drug reports to the Food