SDTM Terminology 2012-06-29.pdf - EVS

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CDISC SDTM Controlled Terminology, 2012-06-29 C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes NCI Code CDISC Submission Value CDISC Synonym CDISC Definition NCI Preferred Term C49592 LB Laboratory Data Laboratory test findings including, but is not limited to hematology, clinical chemistry and urinalysis data. This domain does not include microbiology or pharmacokinetic data, which are stored in separate domains. Laboratory Data Domain C95093 LR Cesarean Section and Delivery Litter Results C95094 MA Macroscopic Findings This domain captures litter based results in female animals for cesarean section and/or delivery components of a study, including litter survival during preweaning. The gross pathology findings recorded at necropsy. Cesarean Section and Delivery Litter Results Domain Macroscopic Findings Domain C49602 MB Microbiology Microbiology specimen findings, including gram stain results, and organisms found. C49603 MH Medical History The medical history dataset includes the subject's prior history at the start of the trial. Examples of subject medical history information could include general medical history, gynecological history, and primary diagnosis. Microbiology Specimen Domain Medical History Domain C95095 MI Microscopic Findings The histopathology findings and microscopic evaluations recorded. Microscopic Findings Domain C49604 ML Meal Data Information regarding the subject's meal consumption, such as fluid intake, amounts, form (solid or liquid state), frequency, etc., typically used for pharmacokinetic analysis. Meal Data Domain C61531 MS Microbiology Susceptibility C49605 OM Organ Measurements C49606 PC Pharmacokinetic Concentration This includes microbiology susceptibility test results, plus results of any other organism-related tests. Findings from organ measurement evaluations. Concentrations of drugs/metabolites in fluids or tissues as a function of time. Microbiology Susceptibility Domain Organ Measurement Domain Pharmacokinetic Concentration Domain C49608 PE Physical Exam Findings collected during a physical examination of the subject. It has findings that are discovered that are related to body systems. Does not include vital signs measurements, which are stored in the vital signs domain. Physical Exam Domain C61529 PG Pharmacogenomi cs Pharmacogenomics findings that initially focus on genotype and gene expression data. Pharmacogenomics Domain C95097 PM Palpable Masses This domain captures information of any palpable masses examined during the experimental phase. Palpable Masses Domain C49607 PP Pharmacokinetic Parameters Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data. Pharmacokinetic Parameters Domain C49609 QS Questionnaires Questionnaire data may include, but are not limited to the following: subject reported outcomes, validated or non-validated questionnaires, and validated or non-validated diaries (i.e. data with a common topicality). Questionnaire Domain C49610 SC Subject Characteristics The subject characteristics domain is for data not collected in other domains that is subject-related. Subject Characteristics Domain Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 50 of 512 -
CDISC SDTM Controlled Terminology, 2012-06-29 C66734 - DOMAIN - Domain Abbreviation Codelist extensible: Yes NCI Code CDISC Submission Value CDISC Synonym CDISC Definition NCI Preferred Term C49616 SE Subject Element The subject element table describes the actual order of elements followed by the subject, together with the start date/time and end date/time for each element. Subject Element Domain C49611 SG Surgery Surgical information. Surgery Domain C95099 SJ Subject Stages The Subject Stages domain captures subject level non-treatment related blocks of time known as stages, such as Gestation, Lactation and Premating. Subject Stages Domain C49612 SK Skin Test Findings from diagnostic skin tests. Skin Test Domain C49613 SL Sleep Polysomnograph y Data C49614 ST Stress (Exercise) Test Data Findings from diagnostic sleep tests (polysomnography). Findings from exercise stress tests. Sleep Polysomnography Domain Stress Exercise Test Data Domain C49615 SU Substance Use The intent of the domain is to capture substance use information that may be used to assess the efficacy and/or safety of therapies that look to mitigate the effects of chronic substance use. C49617 SV Subject Visits The subject visits table describes the actual start and end data/time for each visit of each individual subject. C49618 TA Trial Arms The trial arms table describes each planned arm in the trial. An arm is described as an ordered sequence of elements. C49619 TE Trial Elements The trial elements table describes the element code that is unique for each element, the element description, and the rules for starting and ending an element. C95100 TF Tumor Findings This domain captures the tumor findings of the nonclinical subject. Substance Use Domain Subject Visits Domain Trial Arms Domain Trial Elements Domain Tumor Findings Domain C49620 TI Trial Inclusion/ Exclusion Criteria The trial summary information domain is not subject oriented. It contains one record for each of the inclusion and exclusion criteria for the trial. Trial Inclusion and Exclusion Criteria Domain C95101 TP Trial Paths The trial paths domain is not subject oriented. This domain provides the complete planned non-treatment related sequences of stages for each path in a study. C53483 TS Trial Summary The trial summary information domain is not subject oriented. It contains one record for each trial summary characteristic. C95102 TT Trial Stages The trial stages domain is not subject oriented. It captures non-treatment related planned blocks of time known as stages, such as Gestation, Lactation and Premating. C49621 TV Trial Visits The trial visits table describes the planned order and number of visits in the study within each arm. Trial Paths Domain Trial Summary Domain Trial Stages Domain Trial Visits Domain Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6 Source Date: 2012-06-29 - page 51 of 512 -
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