Transcript NCIt and CDISC CT

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.