CDISC SDTM Controlled Terminology, 2013-04-12 CDISC ... - EVS

CDISC SDTM Controlled Terminology, 2013-04-12
NCI
Code
CDISC
Submission
Value Codelist Name CDISC Definition
Codelist
Extensible
C66784 TOXGRV3 Common Terminology
Criteria for Adverse
Events V3.0
C87162 TOXGRV4 Common Terminology
Criteria for Adverse
Events V4.0
A standard terminology developed to report adverse events occurring in cancer clinical
trials. Common terminology criteria for adverse events (CTCAE) are used in study
adverse event summaries and Investigational New Drug reports to the Food and Drug
Administration. The CTCAE contain a grading scale for each adverse event term
representing the severity of the event. (NCI)
The version 4.0 standard terminology developed to report adverse events occurring in
cancer clinical trials. Common terminology criteria for adverse events (CTCAE) are
used to study adverse event summaries and Investigational New Drug reports to the Food
and Drug Administration. The CTCAE contain a grading scale for each adverse event
term representing the severity of the event. (NCI)
No
No
C66737 TPHASE Trial Phase Clinical trials are broken into three or four phases: Phase I tests a new drug or treatment
for safety in a small group; Phase II expands the study to a larger group of people; Phase
III expands the study to an even larger group of people to measure whether the treatment
actually benefits patients, and whether its benefits exceed its risks; and Phase IV takes
place after the drug or treatment has been licensed and marketed. (NCI)
C102589 TRTEPSD Treatment Episode Terminology relevant to whether an individual is being treated for a disease for the first
time.
Yes
No
C96778 TRTEST Oncology Tumor
Properties Test Name
C96779 TRTESTCD Oncology Tumor
Properties Test Code
C67152 TSPARM Trial Summary
Parameter Test Name
C66738 TSPARMCD Trial Summary
Parameter Test Code
Terminology relevant to the test names that describe the measurement of a tumor.
Terminology relevant to the test codes that describe the measurement of a tumor.
Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding
schema, and primary objective of trial. (NCI)
Individual characteristics of a clinical trial, e.g. description of trial design, trial blinding
schema, and primary objective of trial. (NCI)
Yes
Yes
Yes
Yes
C66739 TTYPE Trial Type The type of clinical trial performed e.g. efficacy, safety. (NCI) Yes
C96780 TUMIDENT Tumor Identification
Results
C96783 TUTEST Tumor Identification
Test Name
C96784 TUTESTCD Tumor Identification
Test Code
Terminology relevant to tumor identification results.
Terminology relevant to the test names that describe tumor assessments for
identification purposes.
Terminology relevant to the test codes that describe tumor assessments for
identification purposes.
Yes
Yes
Yes
C71620 UNIT Unit Terminology codelist used for units within CDISC. Yes
C102590 VCNEVD Vaccination Evidence
Source
C66770 VSRESU Units for Vital Signs
Results
Terminology relevant to the source of information regarding the subject's vaccination
status.
The unit used to record and describe the result of a test investigating a vital sign. (NCI)
Yes
Yes
C67153 VSTEST Vital Signs Test Name The name given to the test that analyzes a particular set of vital signs including
temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI)
C66741 VSTESTCD Vital Signs Test Code The name given to the test that analyzes a particular set of vital signs including
temperature, respiratory rate, heart beat (pulse), and blood pressure. (NCI)
Yes
Yes
Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6
Source Date: 2013-04-12
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