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Property or Attribute C35552 The distinguishing qualities or prominent aspect of a person, object, action, process, or substance. Personal Attribute C19332 The distinguishing qualities or prominent aspects of an individual person. Blood Pressure C54706 Diastolic Blood Pressure C25299 CDISC VSTESTCD = “DIABP” The pressure of the circulating blood against the walls of the blood vessels. The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. Clinical or Research Activity C16203 Intervention or Procedure C25218 Laboratory Procedure C25294 Any specific activity undertaken during the course of a clinical study or research protocol. Activity or measure that produces an effect or that is intended to alter the course of a disease in patient or population. This is a general term encompassing medical, social, behavioral, environmental and other acts that can have preventive and/or therapeutic impact. . A medical procedure that involves testing a sample of blood, urine, or other substance from the body. Tests can help determine a diagnosis, plan treatment, check to see if treatment is working, or monitor the disease over time. Chemistry Test C49237 Protein or Enzyme Type Measurement C64430 Choriogonadotropin Beta Measurement C64851 CDISC LBTESTCD = “HCG” Synonym: “Pregnancy Test” CDISC Definition: A measurement of the Choriogonadotropin Beta in a biological specimen. NCI Defintion: A determination of the presence of Choriogonadotropin Beta protein. NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. Disease, Disorder or Finding C7057 Specification of human conditions relevant to cancer. This includes observations, test results, history, and other concepts relevant to characterization of human cancer-related conditions. Non-neoplastic conditions of interest are also included. Finding C3367 Objective evidence of disease perceptible to the examining physician (sign) and subjective evidence of disease perceived by the patient (symptom).. Finding by Site or System C36278 Cardiovascular System Finding C35552 Patient complaints (symptoms), physical/laboratory findings(signs) related to the cardiovascular system. Blood Pressure Finding C54707 A test result that reports the diastolic and systolic pressure of the blood. Hypertension C3117 Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg Postpartum Hypertension C35802 NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. CDISC SDTM and related initativies All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS Relationship HL7/CDISC SDTM variables specified as packages of Controlled Terminologies Published as an Excel matrixes on CDISC website In OWL format CDISC Clinical Data Interchange Standards Consortium RCRIM Regulated Clinical Research and Information Management, technical committee HL7 “Health Level Seven” NCI Thesaurus UMLS BRIDG Biomedical Research Integrated Domain Group Model CDISC’s Controlled Terminoligy for VSTEST Codes as part of package 1 Published as an Excel matrixes on CDISC website Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Body Frame Size “FRMSIZE” Blood Pressure Body Mass Index “BMI” Diastolic Pressure Systolic Pressure “DIABP” “SYSBP” Body Surface Area “BSA” Action Property or Attribute Conceptual Entities Anatomic Structure System or Substance Finding by Site or System Observation Characteristic Temperature “TEMP” Microanatomic Structure Cardiovascular System Finding Vital Signs Test Name Weight Height “WEIGHT” “HEIGHT” Heart Rate Pulse Rate Respiratory Rate “HR” “PULSE” “RESP” Tissue Connective and Soft Tissue Blood Pressure Finding Soft Tissue Mean Arterial Pressure “MAP” Adipose Tissue “BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Body Frame Size “FRMSIZE” Blood Pressure Body Mass Index “BMI” Body Surface Area “BSA” Diastolic Pressure Systolic Pressure “DIABP” “SYSBP” Action Property or Attribute Conceptual Entities Anatomic Structure System or Substance Finding by Site or System Observation Characteristic Temperature “TEMP” Microanatomic Structure Cardiovascular System Finding Vital Signs Test Name Weight Height “WEIGHT” “HEIGHT” Heart Rate Pulse Rate Respiratory Rate “HR” “PULSE” “RESP” The blood pressure after the contraction of the heart while the chambers of the heart refill with blood. Tissue Connective and Soft Tissue Blood Pressure Finding Soft Tissue Mean Arterial Pressure “MAP” Adipose Tissue “BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes Personal Attribute Body Frame Size “FRMSIZE” Blood Pressure Body Mass Index “BMI” Body Surface Area “BSA” Diastolic Pressure Systolic Pressure “DIABP” “SYSBP” The rhythmic wave within the arteries occurring with each contraction ofthe left ventricle. (Pulse) Action Property or Attribute Conceptual Entities Anatomic Structure System or Substance Finding by Site or System Observation Characteristic Temperature “TEMP” Microanatomic Structure Cardiovascular System Finding Vital Signs Test Name Weight Height “WEIGHT” “HEIGHT” Tissue Heart Rate Pulse Rate Respiratory Rate “HR” “PULSE” “RESP” The rate of the pulse as observed in an artery, expressed as beats per minute. It can be measured at several anatomical sites, including the wrist, neck, temple, groin, behind the knees, or on top of the foot. Connective and Soft Tissue Blood Pressure Finding Soft Tissue Mean Arterial Pressure “MAP” Adipose Tissue “BODYFAT” NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts. Generic dataset structure for all domains Based on the descriptions in the Study Data Tabulation Model document Topic Identifier Timing Grouping Synonym Qual Qual Res Res Qual Var Var Qual Record Qual VSPOS VSLOC VSTESTCD VSORRES Res Example from CDISC SDTM Implementation Guideline version 3.1.2 Hypertension can be seen as a Risk Factor in SDTM Medical History for a specific clinical study A CRF (Case Report Form) asks whether or not the subject had any of a list of 4 specific risk factors, including hypertension, and there is a space for the investigator to write in other risk factors. In SDTM this is classified as a Medical History and below is an example on row 7 describing how a (sligfhly simplified) record in a MH domain could look like Example from CDISC SDTM Implementation Guideline version 3.1.2 Pregnancy can be seen as a type of Disposition event in SDTM domain for Disposition for a specific clinical study From CDISC SDTM Implementation Guideline version 3.1.2, to be published as a controlled terminioligy Primary Use in Health Care per patient Primary use in Drug Development (i.e. Secondary Use of Health Care data in clinical research) Population Secondary Use in Health Care as Knowledge Base Subject SDTM Auhortities Patient Secondary Use Epi / Population / Real life analysis Secondary Use in Drug Development as Knowledge Base Organizing clinical trials information that is to be submitted to the FDA.