They are about 46 domains of which 32 clinical data domains are contained into Interventions, Events and Findings.Six domains for trial design and four domains for special purpose.
SDTM DOMAINS
CLASS
|
DOMAIN NAME
|
DOMAIN DESCRIPTION
|
Special purpose
|
DM
|
Demographics
|
CO
|
Comments
|
|
SE
|
Subject Elements
|
|
SV
|
Subject visits
|
|
Interventions
|
CM
|
Concomitant
Medication
|
EX
|
Exposure
|
|
EC
|
Exposure as
Collected
|
|
SU
|
Substance Use
|
|
PR
|
Procedures
|
|
Events
|
AE
|
Adverse Events
|
CE
|
Clinical Events
|
|
DS
|
Disposition
|
|
DV
|
Protocol
Deviations
|
|
MH
|
Medical History
|
|
HO
|
Healthcare
Encounters
|
|
Findings
|
DA
|
Drug
Accountability
|
DD
|
Death details
|
|
EG
|
ECG test results
|
|
IE
|
Inclusion/exclusion
criterion not met
|
|
IS
|
Immunogenecity
Specimen Assessments
|
|
LB
|
Laboratory test
results
|
|
MB
|
Microbiology
specimen
|
|
MI
|
Microscopic
findings
|
|
MO
|
Morphology
|
|
MS
|
Microbiology
susceptibility test
|
|
PC
|
PK
concentrations
|
|
PP
|
PK parameters
|
|
PE
|
Physical
examination
|
|
QS
|
Questionnaires
|
|
SC
|
Subject
characteristics
|
|
SS
|
Subject status
|
|
VS
|
Vital signs
|
|
RP
|
Reproductive
system findings
|
|
RS
|
Disease response
|
|
TU
|
Tumor identification
|
|
TR
|
Tumor results
|
|
Findings about
|
FA
|
Findings about
|
SR
|
Skin response
|
|
Trial design
|
TA
|
Trial Arms
|
TD
|
Trial disease
assessment
|
|
TE
|
Trial elements
|
|
TV
|
Trial visits
|
|
TI
|
Trial
inclusion/exclusion criteria
|
|
TS
|
Trial summary
|
|
Relationship
datasets
|
SUPPQUAL
|
Supplemental
qualifiers
|
RELREC
|
Related records
|