Diastolic Blood Pressure C25299 C25299 CDISC VSTESTCD = “DIABP” Blood Pressure C54706 The pressure of the circulating blood against the walls of the blood vessels. Personal Attribute C19332 The distinguishing qualities or prominent aspects of an individual person. Property or Attribute C35552 The distinguishing qualities or prominent aspect of a person, object, action, process, or substance. 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.

Choriogonadotropin Beta Measurement C64851 C64851 CDISC LBTESTCD = “HCG” Synonym: “Pregnancy Test” Protein or Enzyme Type Measurement C64430 Chemistry Test C49237 Laboratory Procedure C25294 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. 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. Intervention or Procedure C25218 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.. Clinical or Research Activity C16203 Any specific activity undertaken during the course of a clinical study or research protocol.

Postpartum Hypertension C35802 Hypertension C3117 Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg Blood Pressure Finding C54707 A test result that reports the diastolic and systolic pressure of the blood. Cardiovascular System Finding C35552 Patient complaints (symptoms), physical/laboratory findings(signs) related to the cardiovascular system. Finding by Site or System C36278 Finding C3367 C3367 Objective evidence of disease perceptible to the examining physician (sign) and subjective evidence of disease perceived by the patient (symptom).. Disease, Disorder or Finding C7057 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. NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

CDISC SDTM and related initativies HL7 HL7 “Health Level Seven” CDISC CDISC Clinical Data Interchange Standards Consortium Relationship HL7/CDISC RCRIM Regulated Clinical Research and Information Management, technical committee SDTM variables specified as packages of Controlled Terminologies Published as an Excel matrixes on CDISC website NCI ThesaurusIn OWL format BRIDG BRIDG Biomedical Research Integrated Domain Group Model All terms and concepts are incorporated from NCI Thesaurus thorugh NCI EVS UMLS

CDISC’s Controlled Terminoligy for VSTEST Codes as part of package 1 Published as an Excel matrixes on CDISC website

Vital Signs Test Name Observation Action Heart Rate Heart Rate “HR” Pulse Rate Pulse Rate “PULSE” Respiratory Rate Respiratory Rate “RESP” Personal Attribute Characteristic Weight Weight “WEIGHT” Property or Attribute Blood Pressure Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Body Mass Index Body Mass Index “BMI” Temperature Temperature “TEMP” Conceptual Entities Height Height “HEIGHT” Mean Arterial Pressure Mean Arterial Pressure “MAP” Blood Pressure Finding Cardiovascular System Finding Finding by Site or System Body Frame Size Body Frame Size “FRMSIZE” Adipose Tissue Adipose Tissue “BODYFAT” Soft Tissue Body Surface Area Body Surface Area “BSA” Connective and Soft Tissue Tissue Microanatomic Structure Anatomic Structure System or Substance Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

Vital Signs Test Name Observation Action Heart Rate Heart Rate “HR” Pulse Rate Pulse Rate “PULSE” Respiratory Rate Respiratory Rate “RESP” Personal Attribute Characteristic Weight Weight “WEIGHT” Property or Attribute Blood Pressure Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Body Mass Index Body Mass Index “BMI” Temperature Temperature “TEMP” Conceptual Entities Height Height “HEIGHT” Mean Arterial Pressure Mean Arterial Pressure “MAP” Blood Pressure Finding Cardiovascular System Finding Finding by Site or System Body Frame Size Body Frame Size “FRMSIZE” Adipose Tissue Adipose Tissue “BODYFAT” Soft Tissue Body Surface Area Body Surface Area “BSA” Connective and Soft Tissue Tissue Microanatomic Structure Anatomic Structure System or Substance Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes 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.

Vital Signs Test Name Observation Action Heart Rate Heart Rate “HR” Pulse Rate Pulse Rate “PULSE” Respiratory Rate Respiratory Rate “RESP” Personal Attribute Characteristic Weight Weight “WEIGHT” Property or Attribute Blood Pressure Diastolic Pressure “DIABP” Systolic Pressure “SYSBP” Body Mass Index Body Mass Index “BMI” Temperature Temperature “TEMP” Conceptual Entities Height Height “HEIGHT” Mean Arterial Pressure Mean Arterial Pressure “MAP” Blood Pressure Finding Cardiovascular System Finding Finding by Site or System Body Frame Size Body Frame Size “FRMSIZE” Adipose Tissue Adipose Tissue “BODYFAT” Soft Tissue Body Surface Area Body Surface Area “BSA” Connective and Soft Tissue Tissue Microanatomic Structure Anatomic Structure System or Substance Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes (Pulse)Pulse The rhythmic wave within the arteries occurring with each contraction ofthe left ventricle. 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. NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

TopicIdentifierTiming Grouping Qual Synonym Qual Res Res Qual Var Var Qual Record Qual Res Generic dataset structure for all domains Based on the descriptions in the Study Data Tabulation Model document Example from CDISC SDTM Implementation Guideline version VSTESTCD VSORRES VSPOS VSLOC

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) Secondary Use in Drug Development as Knowledge Base Secondary Use Epi / Population / Real life analysis Secondary Use in Health Care as Knowledge Base Patient Subject Organizing clinical trials information that is to be submitted to the FDA. SDTM Auhortities Population