CDISC SEND Controlled Terminology, 2014-03-28

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CDISC SEND Controlled Terminology, 2014-03-28 CDISC SEND Controlled Terminology, 2014-03-28 Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc NCI CDISC Submission Codelist Name CDISC Definition Codelist Code Value Extensible C66781 AGEU Age Unit Those units of time that are routinely used to express the age of a subject. No C89959 BGTEST Body Weight Gain Terminology for the test names concerned with the increase in overall body Yes Test Name mass. C89960 BGTESTCD Body Weight Gain Terminology for the test codes concerned with the increase in overall body Yes Test Code mass. C88026 BODSYS Body System The terminology that includes concepts relevant to anatomical structure Yes that consists of organs and organ subclasses responsible for certain body functions. C89961 BWTEST Body Weight Test Terminology for the test names concerned with the measurement of body Yes Name mass. C89962 BWTESTCD Body Weight Test Terminology for the test codes concerned with the measurement of body Yes Code mass. C89963 CLCAT Category for Clinical Terminology related to classifications that describe and group clinical Yes Observation observations. C66786 COUNTRY Country A collective generic term that refers here to a wide variety of No dependencies, areas of special sovereignty, uninhabited islands, and other entities in addition to the traditional countries or independent states. (NCI) C90018 CSTATE Consciousness State Terminology related to the sense of awareness of self and of the Yes environment. C89965 DDTEST Death Diagnosis Test Terminology for the test names concerned with the circumstance or No Name condition that results in the death of a living being. C89966 DDTESTCD Death Diagnosis Test Terminology for the test codes concerned with the circumstance or No Code condition that results in the death of a living being. C89967 DESIGN Study Design Terminology related to the plan detailing how a study will be performed in Yes order to represent the phenomenon under examination, to answer the research questions that have been asked, and defining the methods of data analysis. C99074 DIR Directionality CDISC terminology for anatomical location or specimen further detailing Yes directionality. C89968 DSDECOD Standardized Terminology related to the final disposition of the subject in a study. No Disposition Term C90012 EGCATSND SEND ECG Category Terminology related to classifications that describe SEND ECG tests. Yes 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 Yes CDISC. 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 C71113 FREQ Frequency The terminology that includes terms pertaining to frequency within CDISC. Yes C66726 FRM Pharmaceutical The form of the completed pharmaceutical product, e.g. tablet, capsule, Yes Dosage Form injection, elixir, 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. C89969 FWTEST Food and Water Terminology for the test names concerned with the subject's consumption Yes Consumption Test of food and/or water. Name C89970 FWTESTCD Food and Water Terminology for the test codes concerned with the subject's consumption of Yes Consumption Test food and/or water. Code C99073 LAT Laterality CDISC terminology for anatomical location or specimen further detailing Yes the side(s) of interest. C67154 LBTEST Laboratory Test Name Terminology used for laboratory test names of the CDISC Standard Data Yes Tabulation Model. page 1 of 395 NCI CDISC Submission Codelist Name CDISC Definition Codelist Code Value Extensible C65047 LBTESTCD Laboratory Test Code Terminology used for laboratory test codes of the CDISC Standard Data Yes Tabulation Model. C89971 MATEST Macroscopic Findings Terminology for the test names concerned with the findings from a Yes Test Name specimen that are visible to the naked eye. C89972 MATESTCD Macroscopic Findings Terminology for the test codes concerned with the findings from a Yes Test Code specimen that are visible to the naked eye. C90017 MIRESCAT Microscopic Terminology related to the classifications of the results from a microscopic Yes Histopathology Result histopathological analysis. Category C89973 MITEST Microscopic Findings Terminology for the test names concerned with the findings from a Yes Test Name specimen that are visible by microscopic analysis. C89974 MITESTCD Microscopic Findings Terminology for the test codes concerned with the findings from a Yes Test Code specimen that are visible by microscopic analysis. C89975 MTHTRM Method of Terminology related to the method by which an experimental organism is Yes Termination euthanized. This includes events that occur as a step in the induction of death. C66789 ND Not Done Indicates a task, process or examination that has either not been initiated No or completed. (NCI) C88025 NEOPLASM Neoplasm Type The terminology that includes concepts relevant to benign or malignant Yes tissue growth. C90004 NEOSTAT Neoplastic Status Terminology related to the classifications of the results from a No histopathological analysis of a tumor. C66742 NY No Yes Response A term that is used to indicate a question with permissible values of No yes/no/unknown/not applicable. C89976 OMTEST Organ Measurement Terminology for the test names concerned with the measurement of No Test Name organs. C89977 OMTESTCD Organ Measurement Terminology for the test codes concerned with the measurement of organs. No Test Code C95120 PHSPRP Physical Properties Terminology relevant to the test names that describe the physical Yes Test Name characteristics of an entity. C95121 PHSPRPCD Physical Properties Terminology relevant to the test codes that describe the physical Yes Test Code characteristics of an 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 C99075 PORTOT Portion/Totality Qualifier for anatomical location or specimen further detailing the portion or Yes totality, which means arrangement of, or apportioning of an entity. C71148 POSITION Position Terminology codelist used with Body Position within CDISC. Yes C78737 RELTYPE Relationship Type The description of relationship types between a record or set of records. No C66729 ROUTE Route of The course by which a substance was administered in order to reach the Yes Administration site of action in the body. C89981 SBCCDSND SEND Subject Terminology for the test codes concerned with the distinguishing qualities Yes Characteristics Test or prominent aspect of a person, object, action, process, or substance. Code C89980 SBCSND SEND Subject Terminology for the test names concerned with the distinguishing qualities Yes Characteristics Test or prominent aspect of a person, object, action, process, or substance. Name C111113 SDOMAIN SEND Domain A unique, 2-character domain code used in the regulatory submission Yes Abbreviation process of pre-clinical studies. The domain 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. C90000 SEV Severity SEND terminology related to the degree of an occurrence of something No undesirable. C66731 SEX Sex The assemblage of physical properties or qualities by which male is No distinguished from female; the physical difference between male and female; the distinguishing peculiarity of male or female. (NCI) page 2 of 395 NCI CDISC Submission Codelist Name CDISC Definition Codelist Code Value Extensible C66732 SEXPOP Sex of Participants The specific sex, either male, female, or mixed of the subject group being No studied. (NCI) C89982 SNDIGVER SEND Implementation Terminology related to the version of the SEND implementation guide that Yes Guide Version is in use for the study. C77529 SPEC Specimen Terminology related to any material sample taken from a biological entity. Yes C77808 SPECIES Species Terminology related to the common name for an animal used as the test Yes system in a study (e.g., dog, monkey, mouse, rabbit, rat). C90003 SSTYP SEND Study Type The further classification of nonclinical studies performed e.g. absorption, Yes distribution and metabolism. C90002 STCAT Study Category The type of nonclinical study performed e.g. pharmacokinetics, safety Yes pharmacology and toxicology. C77530 STRAIN Strain/Substrain Terminology used to identify the vendor-supplied species, strain, substrain Yes or breed designation for the test system under study. It may combine the species, background strain, substrain, and associated genetic modifications as supplied by the vendor (e.g., C57BL/6, A/J, B6.129-Pparg<tm2Rev>/J, FISCHER 344, SPRAGUE-DAWLEY IGS, WISTAR Kyoto, BEAGLE, CYNOMOLGUS, RHESUS and CHIMPANZEE). C90007 STSPRM SEND Trial Summary Terminology
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