SDTM Terminology 2012-06-29.pdf - EVS

CDISC SDTM Controlled Terminology, 2012-06-29
C66734 - DOMAIN - Domain Abbreviation
Codelist extensible: Yes
NCI Code
CDISC Submission Value
CDISC
Synonym CDISC Definition NCI Preferred Term
C49563 AD Analysis Dataset Datasets used for statistical analysis and reporting by
the sponsor. These are submitted in addition to the data
tabulation datasets.
C49562 AE Adverse Events Adverse events may be captured either as free text or a
pre-specified list of terms.
C49565 AU Autopsy Additional data about deaths, specific to findings from
autopsies.
Analysis Dataset Domain
Adverse Event Domain
Autopsy Domain
C95083 BG Body Weight
Gain
Body weight gain is the actual difference between two
body weight measurements for any given interval for a
subject. This is most commonly shown as the
difference between two consecutive body weight
measurements.
Body Weight Gain Domain
C95084 BH Behavioral This domain captures behavioral testing measurements
on individual subjects.
Behavioral Domain
C49566 BM Bone
Measurements
Findings resulting from evaluations of bone mineral
density.
Bone Measurements Domain
C49567 BR Biopsy Findings resulting from biopsies. Biopsy Domain
C95085 BW Body Weight This domain captures body weights collected for
subjects during the study and at the end of the study
(terminal body weights).
C85441 CE Clinical Events A dataset used to capture clinical events of interest
that would not be classified as adverse events.
Body Weight Domain
Clinical Events Domain
C95086 CL Clinical
Observation
C49568 CM Concomitant
Meds
This domain captures clinical sign information
including ophthalmology, physical examination, and
dermal examination collected in life while executing
the study.
Case report form (CRF) data that captures the
Concomitant and Prior Medications/Therapies used by
the subject. Examples are the Concomitant
Medications/Therapies given on an as needed basis and
the usual Background Medications/Therapies given for
a condition.
Clinical Observation Domain
Concomitant Medication Domain
C49569 CO Comments The Comments dataset accommodates two sources of
comments: 1) those collected alongside other data on
topical case report form (CRF) pages such as Adverse
Events and 2) those collected on a separate page
specifically dedicated to comments.
Comment Domain
C49578 DA Drug
Accountability
C49570 DC Disease
Characteristics
Data regarding the accountability of study drug, such as
information on the receipt, dispensing, return, and
packaging.
Data related to the characteristics of a specific disease
state under study for a subject.
Drug Accountability Domain
Disease Characteristics Domain
C95087 DD Death Diagnosis This domain captures the diagnosis of the cause of
death for a subject.
C49572 DM Demographics The Demographics domain includes a set of essential
standard variables that describe each subject in a
clinical study. It is the parent domain for all other
observations for human clinical subjects
Death Diagnosis Domain
Demographics Domain
Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/terminologyresources/page6
Source Date: 2012-06-29
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