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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. .

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slide1

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.

The pressure of the circulating blood against the walls of the blood vessels.

Blood Pressure

C54706

The blood pressure after the contraction of the heart while the chambers of the heart refill with blood.

Diastolic Blood Pressure

C25299 CDISC VSTESTCD = “DIABP”

NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

slide2

Any specific activity undertaken during the course of a clinical study or research protocol.

Clinical or Research Activity

C16203

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. .

Intervention or Procedure

C25218

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.

Laboratory Procedure

C25294

Chemistry Test

C49237

Protein or Enzyme Type Measurement

C64430

CDISC Definition: A measurement of the Choriogonadotropin Beta in a biological specimen. NCI Defintion: A determination of the presence of Choriogonadotropin Beta protein.

Choriogonadotropin Beta Measurement

C64851 CDISC LBTESTCD = “HCG”Synonym: “Pregnancy Test”

NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

slide3

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.

Disease, Disorder or FindingC7057

Objective evidence of disease perceptible to the examining physician (sign) and subjective evidence of disease perceived by the patient (symptom)..

Finding C3367

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.

Pathological increase in blood pressure; a repeatedly elevated blood pressure exceeding 140 over 90 mmHg

Hypertension

C3117

Postpartum Hypertension

C35802

NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

cdisc sdtm and related initativies
CDISC SDTM and related initativies

All terms and conceptsare incorporated from NCI Thesaurus thorugh NCI EVS

SDTM variables specifiedas packages of ControlledTerminologies

Published as an Excel matrixeson CDISC website

In OWL format

NCI Thesaurus

CDISCClinical Data Interchange Standards Consortium

UMLS

RCRIM

Regulated Clinical Research and Information Management,technical committee

Relationship HL7/CDISC

BRIDGBiomedical Research Integrated Domain Group Model

HL7 “Health Level Seven”

slide5

CDISC’s Controlled Terminoligy for VSTEST Codesas part of package 1

Published as an Excel matrixeson CDISC website

slide6
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes

Personal Attribute

Action

Property or Attribute

Conceptual Entities

Anatomic StructureSystem or Substance

Finding by Site or System

Body Frame Size“FRMSIZE”

Blood Pressure

Body Mass Index“BMI”

Body Surface Area“BSA”

Observation

Characteristic

Temperature“TEMP”

Microanatomic Structure

Cardiovascular System Finding

Diastolic Pressure

“DIABP”

Systolic Pressure

“SYSBP”

Vital Signs Test Name

Weight“WEIGHT”

Height“HEIGHT”

Tissue

Heart Rate“HR”

Pulse Rate“PULSE”

Respiratory Rate“RESP”

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.

slide7
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes

Personal Attribute

Action

Property or Attribute

Conceptual Entities

Anatomic StructureSystem or Substance

Finding by Site or System

Body Frame Size“FRMSIZE”

Blood Pressure

Body Mass Index“BMI”

Body Surface Area“BSA”

Observation

Characteristic

Temperature“TEMP”

Microanatomic Structure

Cardiovascular System Finding

Diastolic Pressure

“DIABP”

Systolic Pressure

“SYSBP”

Vital Signs Test Name

Weight“WEIGHT”

Height“HEIGHT”

Tissue

Heart Rate“HR”

Pulse Rate“PULSE”

Respiratory Rate“RESP”

Connective and Soft Tissue

Blood Pressure Finding

Soft Tissue

Mean Arterial Pressure“MAP”

The blood pressure after the contraction of the heart while the chambers of the heart refill with blood.

Adipose Tissue“BODYFAT”

NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

slide8
Concept structures in NCI’s Thesaurus for Concepts that have been in aligned to proposed CDISC’s VSTEST Codes

Personal Attribute

Action

Property or Attribute

Conceptual Entities

Anatomic StructureSystem or Substance

Finding by Site or System

Body Frame Size“FRMSIZE”

Blood Pressure

Body Mass Index“BMI”

Body Surface Area“BSA”

Observation

Characteristic

Temperature“TEMP”

Microanatomic Structure

Cardiovascular System Finding

(Pulse)

Diastolic Pressure

“DIABP”

Systolic Pressure

“SYSBP”

Vital Signs Test Name

Weight“WEIGHT”

Height“HEIGHT”

Tissue

Heart Rate“HR”

Pulse Rate“PULSE”

Respiratory Rate“RESP”

Connective and Soft Tissue

Blood Pressure Finding

The rhythmic wave within the arteries occurring with each contraction ofthe left ventricle.

Soft Tissue

Mean Arterial Pressure“MAP”

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.

Adipose Tissue“BODYFAT”

NCI’s Thesaurus relates concept in hierarical structure by using super- and sub-concepts.

slide9

Generic dataset structure for all domainsBased on the descriptions in the Study Data Tabulation Model document

RecordQual

Topic

Identifier

Timing

GroupingQual

SynonymQual

Res

ResQual

Var

VarQual

VSPOS

VSLOC

VSTESTCD

VSORRES

Res

Example from CDISC SDTM Implementation Guideline version 3.1.2

slide10

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

slide11

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

slide12

Primary use inDrug Development (i.e. Secondary Use of Health Care data in clinical research)

Primary Usein Health Careper patient

Secondary Usein Health Careas Knowledge Base

Population

Subject

SDTM

Auhortities

Organizing clinical trials information that is to be submitted to the FDA.

Patient

Secondary UseEpi / Population / Real life analysis

Secondary Usein Drug Developmentas Knowledge Base