Comprehensive

Classification
of

SDTM
Domains
A Beginner's Guide with Sample
Tables and Examples.
 SPECIAL PURPOSE
DOMAINS

DM CO SV SE

GENRAL
OBSERVATION CLASS

i. INVESTIGATINALS ii. EVENTS iii. FINDINGS

EX AE LB RS DA

EC CE EG IS PE

VS PP MB
CM MH

PC SC MO
SU DS
QS MI TR
PR DV
MS TU DD
HO
RP SS IE

FINDING ABOUT TRIAL DESING RELATIONSHIP

FA TA SUPP

SR TE RELREC

TV

TI

TS
 Special Purpose
Domains
DM (Demographics Domain) :
The Demographics (DM) domain contains demographic
information for each subject, such as age, sex, race, and
other baseline characteristics. This information helps define
the population in a clinical trial and enables subgroup
analysis.

Purpose:

To record essential characteristics of each subject in the trial

for population segmentation.

Example:
In a clinical trial studying the effect of a new medication, the
DM domain captures the baseline characteristics such as
age, gender, and ethnicity of the subjects enrolled in the
study. This data is crucial for understanding the subject
profile.

USUBJID AGE SEX RACE ETHNIC COUNTRY ARM

01-001 45 M Caucasian Not Hispanic USA Placebo

01-002 30 F Asian Not Hispanic USA Treatment

01-003 28 M African Hispanic Canada Placebo

CO (Comments)

The Comments (CO) domain captures additional free-text

comments or clarifications related to other records or data
points in the study. It is used when further explanation is
needed beyond structured data.

Purpose:

To provide contextual or additional qualitative information

that may not be captured in other domains.

Example:

For example, a subject’s adverse event might have a

detailed explanation or clarification about the severity or
conditions in the CO domain.

USUBJID DOMAIN COMMENT IDVAR IDVARVAL

01-001 AE Patient reported moderate pain AESEQ 1

01-002 LB Sample hemolyzed, retest ordered LBSEQ 2

01-003 EX Dose reduced due to side effects EXSEQ 3

SV (Subject Visits)

The Subject Visits (SV) domain provides information about

the timing and details of each subject’s visits to the study
site. It documents when and how often a subject was seen
by the investigator

Purpose:

To track and document the planned and actual visits of

subjects throughout the clinical trial.

Example:

In a multi-visit study, the SV domain logs details about each

visit, including the visit number, start date, and end date. For
example, Visit 1 might be the screening visit, while Visit 2 is
for baseline measurements.

USUBJID VISITNUM VISIT SVSTDTC SVENDTC

01-001 1 Screening Visit 2024-05-01 2024-05-01

01-001 2 Baseline Visit 2024-05-15 2024-05-15

01-002 3 Screening Visit 2024-05-03 2024-05-03

SE (Subject Elements)
The Subject Elements (SE) domain captures the different
phases (elements) that a subject goes through during the
trial, such as screening, treatment, and follow-up.

Purpose:

To document the timing and sequence of trial elements for

each subject, allowing clear tracking of their progression
through different study phases.

Example:

In a clinical trial, a subject might go through multiple stages

like the "Screening" phase, "Treatment" phase, and "Follow-
up" phase. SE captures the dates for each of these elements.

USUBJID ELEMENT SVSTDTC SEENDTC

01-001 Screening 2024-05-01 2024-05-15

01-001 Treatment 2024-05-16 2024-06-01

01-002 Screening 2024-05-03 2024-05-17

 General Observation
Class Domains
Interventional Domains

EX (Exposure):

The Exposure (EX) domain records details about the

treatment administered to the subject, such as the drug
name, dose, route, and date of administration.

Purpose:

To track the administration of investigational products or

interventions to subjects in the trial.

Example:

In a study where patients receive a daily dose of medication,

the EX domain logs the amount, route (oral, injection), and
dates for each dose given.

USUBJID EXTRT EXDOSE EXROUTE EXSTDTC

01-001 Drug A 500 mg Oral 2024-05-16

01-002 Drug B 200 mg Injection 2024-05-17

01-003 Drug A 500 mg Oral 2024-05-18

CM (Concomitant Medications):

The Concomitant Medications (CM) domain captures

information about medications that subjects are taking
concurrently with the study treatment but are not part of
the study protocol.

Purpose:

To record additional medications that might impact the

subject's health or interact with the study drug.

Example:

If a subject is taking aspirin for a pre-existing condition while

also receiving the study drug, the CM domain captures
details about the aspirin dose and frequency.

USUBJID CMTRT CMDOSE CMROUTE EXSTDTC

01-001 Aspirin 100 mg Oral 2024-05-01

01-002 Metformin 500 mg Oral 2024-05-03

01-003 Ibuprofen 200 mg Oral 2024-05-05

SU (Substance Use):

The Substance Use (SU) domain records information about a

subject's use of tobacco, alcohol, drugs, or other substances
during the study. It provides insights into lifestyle factors
that may affect study outcomes.

Purpose:

To document the subject’s use of substances that could

influence the clinical trial results or interact with the
treatment being studied.

Example:

In a clinical trial, if a subject is a smoker, the SU domain will

record details such as the type of tobacco used, the
frequency, and duration of use. This helps in evaluating how
substance use may influence the study’s effectiveness.

USUBJID SUTRT SUOCCUR SUFREQ EXSTDTC

01-001 Cigarettes Yes 10/day 2024-05-01

01-002 Alcohol Yes Once a week 2024-05-03

01-003 Marijuana No N/A N/A

EC (Exposure as Collected):

The Exposure as Collected (EC) domain captures the raw

exposure data as reported by the site, without converting it
into a standard dose or format. It allows for the capture of
original data without standardization.

Purpose:

To preserve the original format of drug exposure data for

regulatory submission and ensure accurate raw data
collection.

Example:

If a subject received a specific drug in milliliters instead of

the standardized milligram dose, the EC domain captures
the original dosage as recorded.

USUBJID ECRAWDOSE ECRAWUNIT ECROUTE ECSTDTC

01-001 20 mL Oral 2024-05-02

01-002 0.5 g Injection 2024-05-03

01-003 10 mL Oral 2024-05-04

PR (Procedures):

The Procedures (PR) domain records details of any medical,

surgical, or diagnostic procedures that subjects undergo
during the study. This can include anything from blood
draws to surgical interventions.

Purpose:

To track and document all medical procedures performed

on the subjects during the trial, which may affect outcomes
or safety evaluations.

Example:

In a dermatological clinical trial, a subject may undergo a

skin biopsy. The PR domain will capture details like the date
of the procedure, the method used, and the site of the
biopsy.

USUBJID PRTRT PRLOC PRSTDTC PRTYPE

01-001 Skin Biopsy Right Arm 2024-05-10 Surgical

01-002 Blood Draw Left Arm 2024-05-11 Diagnostic

01-003 Endoscopy Stomach 2024-05-12 Diagnostic

 Event Domains
AE (Adverse Events)

The Adverse Events (AE) domain captures details about any

untoward medical occurrences experienced by the subject
during the clinical trial, regardless of whether it is related to
the study treatment.

Purpose:

To track and document any adverse effects experienced by

subjects to assess safety and risk of the investigational
product.

Example:

If a subject reports nausea during the trial, the AE domain

captures details such as the severity, start and end dates,
and the investigator’s assessment of whether it was related
to the treatment.

USUBJID AETERM AESEV AEOUT AESTDTC AEREL

01-001 Nausea Moderate Recovered 2024-05-05 Possible

01-002 Headache Mild Recovered 2024-05-06 Not Related

01-003 Skin Rash Severe Ongoing 2024-05-07 Related

CE (Clinical Events)
The Clinical Events (CE) domain captures medically
important events that occur during the study, which may or
may not be adverse events. These events could be related to
the study treatment or other clinical factors.

Purpose:

To record significant clinical events that impact the subject's

health during the study, whether related to treatment or
not.

Example:

For instance, a subject in a clinical trial experiences a heart

attack during the study. The CE domain records this event,
including relevant clinical details.

USUBJID CETERM CEOUT CESTDTC CEENDTC

01-001 Heart Attack Recovered 2024-05-08 2024-05-09

01-002 Severe Infection Ongoing 2024-05-10 N/A

01-003 Fracture Recovered 2024-05-12 2024-05-14

MH (Medical History)

The Medical History (MH) domain contains information

about the subject’s medical history prior to the study, such
as chronic illnesses or past surgeries, that could influence
the study outcomes.

Purpose:

To capture pre-existing conditions or past medical events

that may impact the analysis of study results.

Example:

A subject with a history of hypertension enrolled in a drug

trial would have this recorded in the MH domain. The data
helps in understanding whether prior conditions might
influence the drug’s effectiveness.

USUBJID MHTERM MHSTDTC MHONGO

01-001 Hypertension 2010-03-05 Yes

01-002 Asthma 2005-08-12 No

01-003 Diabetes Type 2 2012-09-14 Yes

DS (Disposition)

The Disposition (DS) domain records subject's trial status,

such as whether they completed the study or dropped out,
and the reasons for discontinuation.

Purpose:

To document the subject’s status and any changes in their

participation in the study, including reasons for withdrawal
or early termination.

Example:

If a subject withdraws from the study due to an adverse

event, the DS domain captures this event along with the
reason.

USUBJID DSTERM DSDECOD DSSTDTC

01-001 Withdrawal Adverse Event 2024-06-01

01-002 Completed Study Completed 2024-06-05

01-003 Early Termination Protocol Violation 2024-06-10

DV (Protocol Deviations)

The Protocol Deviations (DV) domain captures any

deviations from the study protocol that occurred during the
trial, such as missed visits or incorrect dosages.

Purpose:

A subject missing a scheduled visit would be recorded in the

DV domain, including the reason and impact of the
deviation.

Example:

If a subject withdraws from the study due to an adverse

event, the DS domain captures this event along with the
reason.

USUBJID DVTERM DVSTDTC DVREAS

01-001 Missed Visit 2024-05-20 Personal

01-002 Incorrect Dosage 2024-05-21 Site Error

01-003 Late Visit 2024-05-22 Transport Issue

 HO (Healthcare Encounters Domain)

The Healthcare Encounters (HO) domain is used to capture

information about medical visits or healthcare interactions
that a subject experiences during the course of a clinical
trial. This domain documents any encounter a subject has
with a healthcare professional, whether it's for study-related
reasons or not.

Purpose:

The purpose of the HO domain is to record details about the

encounters a subject has with healthcare providers, such as
hospital visits, doctor consultations, or emergency room
admissions. This data can help identify patterns in
healthcare usage and may provide insight into the safety
and efficacy of the treatment under study.

Example:

In a clinical trial for a new dermatological cream, a subject

may visit a dermatologist for an unscheduled consultation
due to a skin reaction. This encounter, even though it's not a
formal part of the study, is recorded in the HO domain to
track the overall healthcare interactions of the subject.

STUDYID USUBJID HOVISIT HOLOC HODTC HOEVAL

Dermatologist
STUDY-001 01-001 Unscheduled Visit Hospital 2024-07-15 Visit
Emergency
STUDY-001 01-002 Emergency Visit ER 2024-07-18
Physician
STUDY-001 General
01-003 Routine Checkup Clinic 2024-07-20
Practitioner
 Finding Domains
LB (Laboratory Test Results)

The Laboratory Test Results (LB) domain captures the results

of laboratory tests conducted during the study, such as
blood tests or urine analysis. These tests are critical for
evaluating the safety and effectiveness of the investigational
treatment.

Purpose:

To collect and report data from various lab tests performed

on subjects, which help in determining the clinical safety
profile of the drug.

Example:

In a clinical trial testing a new dermatological treatment,

routine blood tests are conducted to monitor liver function.
The LB domain records each test result.

USUBJID LBTEST LBORRES LBSTRESC LBSTDTC

01-001 ALT (U/L) 35 35 2024-06-02

01-002 Creatinine (mg/dL) 1.2 1.2 2024-06-02

01-003 Hemoglobin (g/dL) 14 14 2024-06-03

PC (Pharmacokinetics Concentration)

The Pharmacokinetics Concentration (PC) domain records

measurements of drug concentration in the subject’s blood
or other biological samples. These data are essential to study
how the drug is absorbed, distributed, metabolized, and
excreted.

Purpose:

To track and analyze the concentration levels of the

investigational drug in biological samples over time,
providing insight into the drug's pharmacokinetics.

Example:

In a pharmacokinetic study, blood samples are taken at

different time intervals to measure drug concentration. The
PC domain records these measurements to understand the
drug’s behavior in the body.

USUBJID PCTEST PCORRES PCSTRESC PCDTC

01-001 Drug Level (ng/mL) 150 150 2024-06-02

01-002 Drug Level (ng/mL) 120 120 2024-06-02

01-003 Drug Level (ng/mL) 180 180 2024-06-03

QS (Questionnaires)

The Questionnaires (QS) domain captures responses to

standardized questionnaires given to subjects during the
clinical trial. These may include quality of life assessments,
mental health evaluations, or symptom checklists.

Purpose:

To gather subjective data directly from the subjects, which

can be used to assess patient-reported outcomes and
quality of life during the trial.

Example:

In a dermatology study, a subject may be asked to complete

a questionnaire about the severity of their skin condition
before and after treatment. The QS domain captures these
responses.

USUBJID QSTEST QSORRES QSSTRESC QSSTDTC

01-001 Skin Condition Severe Severe 2024-06-04

01-002 Quality of Life Good Good 2024-06-05

01-003 Pain Intensity Mild Mild 2024-06-06

MS (Microbiology Specimen)

The Microbiology Specimen (MS) domain records the details

of microbiology specimens collected from subjects, such as
skin swabs or blood cultures, and the results of
microbiological tests.

Purpose:

To document and analyze microbiology data, which can

help in identifying infections or microbial presence that may
affect the study outcomes.

Example:

If a subject develops a skin infection during a dermatology

trial, a microbiological test is conducted to identify the
organism. The MS domain records this data.

USUBJID MSTEST MSORRES MSSTRESC QSSTDTC

01-001 Bacterial Culture Positive Positive 2024-06-07

01-002 Viral PCR Negative Negative 2024-06-08

01-003 Fungal Culture Positive Positive 2024-06-09

RP (Reproductive System Findings)

The Reproductive System Findings (RP) domain captures

observations related to the reproductive system, including
tests such as hormone levels or physical examinations of
reproductive organs.

Purpose:

To document findings and test results related to

reproductive health, which could be significant in clinical
trials where reproductive function is a concern.

Example:

In a fertility study, hormone levels are regularly monitored to

assess ovarian function. The RP domain captures these
hormone levels.

USUBJID RPTEST RPORRES RPSTRESC RPSTDTC

01-001 Estrogen (pg/mL) 200 200 2024-06-10

Progesterone
01-002 (ng/mL)
12 12 2024-06-11

01-003 LH (IU/L) 25 25 2024-06-12

RS (Radiologic Findings)

The Radiologic Findings (RS) domain captures results from

imaging studies such as X-rays, MRIs, or CT scans. These
tests help assess the structural changes or abnormalities in
the body.

Purpose:

To collect and report data from radiologic imaging, which is

important for evaluating disease progression or treatment
response in clinical trials.

Example:

In a trial for bone health, subjects undergo regular X-rays to

monitor bone density. The RS domain records these
radiologic findings.

USUBJID RSTEST RSORRES RPSTRESC RSSTDTC

X-Ray
01-001 Normal Normal 2024-06-13
(Bone Density)
01-002 MRI (Brain) No Abnormality N/A 2024-06-14

01-003 CT Scan (Lungs) Abnormal Abnormal 2024-06-15

PP (Pharmacokinetics Parameters)

The Pharmacokinetics Parameters (PP) domain captures

derived pharmacokinetic parameters, such as the area
under the curve (AUC) or the half-life of the drug. These
parameters help in understanding how the drug behaves in
the body over time.

Purpose:

To provide detailed analysis of the pharmacokinetic behavior

of the drug, allowing researchers to evaluate drug
absorption, metabolism, and excretion.

Example:

After collecting blood samples for drug concentration, the

PP domain calculates key parameters like the drug’s half-life
and maximum concentration.

USUBJID PPTEST PPORRES PPSTRESC RSSTDTC

01-001 Cmax (ng/mL) 200 200 2024-06-16

01-002 AUC (ng·h/mL) 1000 1000 2024-06-17

01-003 Half-Life (hours) 6 6 2024-06-18

 EG (ECG Test Results)

The ECG Test Results (EG) domain records the results of

electrocardiogram (ECG) tests conducted on subjects during
a study.

Purpose:

To document findings from ECG tests, which assess the

electrical activity of the heart. These results are critical for
identifying any cardiac abnormalities that may be related to
the treatment.

Example:

In a dermatology trial, subjects may undergo ECGs to

monitor cardiac health while using an investigational
treatment, especially if there are concerns about cardiac
side effects.

STUDYID USUBJID HOVISIT HOLOC HODTC HOEVAL

STUDY-001 01-001 Unscheduled Visit Hospital 2024-07-15 Dermatologist Visit

Emergency
STUDY-001 01-002 Emergency Visit ER 2024-07-18 Physician
General
STUDY-001 01-003 Routine Checkup Clinic 2024-07-20 Practitioner
 VS (Vital Signs)

The Vital Signs (VS) domain captures the measurements of

critical physiological parameters like heart rate, blood
pressure, and body temperature.

Purpose:

To track a subject's vital signs over the course of the study to

detect any abnormal physiological changes that may
indicate side effects or other medical concerns.

Example:

During a dermatological trial, the investigators monitor

subjects' vital signs to ensure that no systemic reactions to
the treatment, such as fever or hypertension, occur.

STUDYID USUBJID VSTEST VSORRES VSDTC VSLOC

STUDY-001 01-001 Heart Rate 72 bpm 2024-07-12 Clinic

STUDY-001 01-002 Blood Pressure 120/80 mmHg 2024-07-15 Hospital

 IS (Immunogenicity Specimen
Assessments)

The Immunogenicity Specimen Assessments (IS) domain

contains the results of tests performed on specimens to
evaluate immune responses, often for vaccines or biologic
therapies.

Purpose:

To measure how a subject's immune system responds to the

investigational product, which is critical for understanding
the immunogenicity profile of the treatment.

Example:

If a dermatology study involves a new biologic treatment,

the IS domain will track how the subjects' immune systems
react to it, such as by measuring antibody levels.

STUDYID USUBJID ISTEST ISORRES ISDTC ISLOC

STUDY-001 01-001 Antibody Level 35 µg/mL 2024-07-20 Clinic Lab

STUDY-001 01-002 T-cell Response Positive 2024-07-22 Research Lab

SC (Subject Characteristics)

The Subject Characteristics (SC) domain records baseline

demographic data and other important characteristics
about the subjects enrolled in the study.

Purpose:

To document key characteristics such as age, sex, ethnicity,

and other relevant data that can affect how a subject
responds to the investigational treatment.

Example:

In a dermatology trial, the SC domain might capture

subjects’ skin type or severity of the dermatological
condition, which could influence treatment outcomes.

STUDYID USUBJID SCTEST SCORRES SCDTC

STUDY-001 01-001 Fitzpatrick Skin Type Type III 2024-07-01

STUDY-001 01-002 Severity of Eczema Moderate 2024-07-03

01-003 Pain Intensity Mild Mild 2024-06-06

MI (Microscopic Findings)

The Microscopic Findings (MI) domain records the results of

histopathological analyses of tissue samples under a
microscope.

Purpose:

To document the microscopic findings from tissue biopsies,

which are vital in evaluating disease pathology or the effects
of the treatment at a cellular level.

Example:

In a study testing a new dermatological cream, skin biopsies

may be taken from subjects and analyzed under a
microscope to evaluate the treatment's effect on skin cell
inflammation.

STUDYID USUBJID MITEST MIORRES MIDTC

STUDY-001 01-001 Inflammation Count Moderate 2024-07-10

STUDY-001 01-002 Cell Proliferation High 2024-07-12

01-003 Pain Intensity Mild Mild 2024-06-06

SS (Subject Status)

The Subject Status (SS) domain captures the status of

subjects at specific time points, such as whether they are
alive, dead, or have withdrawn from the study.

Purpose:

To provide information on the overall status of subjects

during the trial, ensuring that critical changes in their health
or participation are properly recorded.

Example:

In a dermatology study, if a subject withdraws due to a

severe adverse event, this would be recorded in the SS
domain to track the reason for discontinuation.

STUDYID USUBJID SSTEST SSORRES SSDTC

STUDY-001 01-001 Subject Status Active 2024-07-05

STUDY-001 01-002 Subject Status Withdrawn 2024-07-12

01-003 Pain Intensity Mild Mild 2024-06-06

DA (Drug Accountability)

The Drug Accountability (DA) domain tracks the amount of

investigational product dispensed, returned, or otherwise
accounted for during the trial.

Purpose:

To ensure that the investigational drug is managed properly,

tracking how much was dispensed to subjects and how
much was returned or lost.

Example:

In a dermatology trial, investigators would track how much

cream was given to subjects and ensure the remaining
product is returned and accounted for at each visit.

STUDYID USUBJID DATEST DAORRES DADTC

STUDY-001 01-001 Cream Dispensed 100g 2024-07-15

STUDY-001 01-002 Cream Returned 80g 2024-07-22

01-003 Pain Intensity Mild Mild 2024-06-06

PE (Physical Examination)

The Physical Examination (PE) domain captures the results

of physical exams conducted on subjects during the study.

Purpose:

To document the findings from routine physical exams,

which provide a general assessment of the subject's health
status.

Example:

In a dermatology trial, physical exams might focus on

assessing the skin's condition and noting any lesions, rashes,
or other abnormalities.

STUDYID USUBJID PETEST PEORRES PEDTC

STUDY-001 01-001 Skin Condition Clear 2024-07-10

STUDY-001 01-002 Skin Condition Mild Rash 2024-07-15

01-003 Pain Intensity Mild Mild 2024-06-06

MB (Microbiology Specimen)

The Microbiology Specimen (MB) domain contains

information on microbiological tests performed on
specimens, such as bacterial cultures or viral loads.

Purpose:

To track microbiological assessments that help determine

the presence of infections or other microbial activity in
subjects.

Example:

During a dermatology study, swabs may be taken from

infected skin areas and cultured to identify the presence of
bacteria, which is recorded in the MB domain.

STUDYID USUBJID MBTEST MBORRES MBDTC

STUDY-001 01-001 Bacterial Culture Positive 2024-07-08

STUDY-001 01-002 Viral Load Negative 2024-07-11

01-003 Pain Intensity Mild Mild 2024-06-06

MO (Morphology)

The Morphology (MO) domain records morphological

assessments of tissue samples, describing the size, shape,
and appearance of tissues under study.

Purpose:

To provide detailed descriptions of the physical attributes of

tissues, which is important for understanding pathological
changes.

Example:

In a dermatological study, biopsies may be examined for any

morphological changes in skin structure, which could
indicate the effectiveness or side effects of the treatment.

STUDYID USUBJID MOTEST MOORRES MODTC

STUDY-001 01-001 Tissue Thickness Increased 2024-07-14

STUDY-001 01-002 Cell Size Enlarged 2024-07-16

01-003 Pain Intensity Mild Mild 2024-06-06

TR (Tumor Response)

The Tumor Response (TR) domain captures findings related

to the response of tumors to the investigational product.

Purpose:

To document changes in tumor size or appearance during

the study, which are critical for evaluating the effectiveness
of cancer treatments.

Example:

In studies involving skin cancer treatment, tumor responses

are recorded in the TR domain to track reductions in tumor
size or progression.

STUDYID USUBJID TRTEST TRORRES TRDTC

STUDY-001 01-001 Tumor Size Decreased 2024-07-12

STUDY-001 01-002 Tumor Growth No Change 2024-07-15

01-003 Pain Intensity Mild Mild 2024-06-06

DD (Death Details)

The Death Details (DD) domain captures information about

deaths that occur during the study, including the cause and
timing.

Purpose:

To document deaths among study subjects, which is

important for evaluating the safety profile of the
investigational product.

Example:

If a subject in a dermatological trial dies due to an unrelated

cause, this information is recorded in the DD domain for
transparency.

STUDYID USUBJID DDTEST DDORRES DDDTC

STUDY-001 01-001 Cause of Death Heart Attack 2024-07-19

STUDY-001 01-002 Date of Death 2024-07-20 2024-07-20

01-003 Pain Intensity Mild Mild 2024-06-06

IE (Inclusion/Exclusion Criteria)

The Inclusion/Exclusion Criteria (IE) domain captures

whether a subject meets or does not meet the predefined
criteria for participation in the study.

Purpose:

To document which inclusion or exclusion criteria a subject

met or did not meet at the start of the study.

Example:

In a dermatology study, certain subjects may be excluded if

they have a history of severe allergic reactions. This
information would be recorded in the IE domain.

STUDYID USUBJID IETEST IEORRES IEDTC

STUDY-001 01-001 History of Allergies Excluded 2024-07-05

STUDY-001 01-002 Age ≥18 Included 2024-07-07

01-003 Pain Intensity Mild Mild 2024-06-06

TU (Tumor Identification)

The TU (Tumor Identification) domain is primarily used in

oncology studies to document tumors identified in subjects.
This domain focuses on key characteristics of each tumor,
such as its location, type, and other relevant details. It's a
crucial part of clinical trials for cancer treatments, where
tumor tracking is needed to measure the efficacy of a
treatment or intervention.

Purpose:

To capture detailed information about tumors, including

their anatomical location, size, and identification date. This
data is used to monitor tumor progression, regression, or
stability over time.

Example:

In a clinical trial assessing a new treatment for skin cancer,

the TU domain would be used to document tumors found
during the study. For example, if a patient develops multiple
skin tumors, each would be recorded in the TU domain with
details such as the anatomical site and whether it was a new
or existing tumor.

STUDYID USUBJID TULOC TUTESTCD TUDTC

STUDY-001 SUBJ-001 Skin (Arm) TUMORID 2024-07-01

STUDY-001 SUBJ-001 Skin (Back) TUMORID 2024-07-08

01-003 Pain Intensity Mild Mild 2024-06-06

 Finding About
Domains
Finding About (FA) :
The Finding About (FA) domain captures additional details
about observations recorded in other findings domains. For
instance, if there is an observation about a subject’s
condition in the QS domain, the FA domain can capture
additional characteristics like severity or relationship to
treatment.

Purpose:

To provide supplementary data for observations in other

findings domains, enriching the context and providing a
more complete picture.

Example:

If a questionnaire (QS) records a subject’s pain, the FA

domain could include more information about the location
or severity of the pain.

USUBJID FATEST FAORRES FASTRES FASTDTC

01-001 Pain Severity Moderate Moderate 2024-06-19

01-002 Skin Irritation Severe Severe 2024-06-20

01-003 Fatigue Level Mild Mild 2024-06-21

SR (Subject Relationships)

The SR domain records relationships between multiple

subjects in a study. These relationships may be biological,
familial, or other types of relationships relevant to the study
outcomes. For example, in studies involving twins or family
members, this domain helps identify how one subject's data
might influence another's, providing a clearer context for
data analysis.

Purpose:

To document and explain the relationships between

different subjects within a clinical trial. The domain provides
insights into how these relationships may influence the
outcomes of the study, particularly in genetic, familial, or
socially related studies.

Example:

In a genetic study where twins are participating, the SR

domain would document the relationship between the two
twin subjects. For instance, if one subject is a donor in a
transplant study, and the other is the recipient, the
relationship would be recorded in the SR domain to clarify
their biological and treatment-related connection.

STUDYID USUBJID RELID RELTYPE RELSUBJ

STUDY-001 SUBJ-001 001 TWIN SUBJ-002

STUDY-001 SUBJ-001 001 TWIN SUBJ-001

01-003 Pain Intensity Mild Mild 2024-06-06

 Trial Design
Domains
TA (Trial Arms)
The Trial Arms (TA) domain defines the different arms of the
clinical study. Each arm represents a group of subjects that
receives a specific treatment or intervention.

Purpose:

To document the various treatment groups in a trial,

indicating whether a subject is assigned to a treatment
group, a control group, or a placebo group. This helps in
tracking how different subjects were treated during the
study.

Example:

In a clinical trial for a new dermatological cream, the TA

domain tracks which subjects received the investigational
cream, which received a placebo, and which were part of the
control group.

STUDYID ARMCD ARM ARMN

01-001 ARM01 Investigational Drug 1

01-001 ARM02 Placebo 2

01-001 ARM03 Control 3

TE (Trial Elements)

The Trial Elements (TE) domain outlines the distinct phases

or periods of the trial that subjects pass through, such as
screening, treatment, and follow-up phases.

Purpose:

To capture the structure of the clinical trial by defining each

element or time period in which certain procedures are
carried out. This helps ensure that subjects are following the
correct sequence of study activities.

Example:

In a dermatology trial, subjects may go through three

phases: screening, treatment (where they apply the cream),
and follow-up to monitor skin reactions. The TE domain
tracks these phases.

STUDYID ETCD ELEMENT EPOCH

01-001 SCRN Screening Screening

01-001 TREAT Treatment Treatment

01-001 FUP Follow-Up Follow-Up

TV (Trial Visits)

The Trial Visits (TV) domain records the schedule of planned

visits during the trial. Each visit is tied to a specific time
point and involves certain procedures.

Purpose:

To provide a timeline of when subjects should attend visits

throughout the study, along with the procedures expected
at each visit. This ensures that subjects attend at predefined
intervals.

Example:

In a dermatology study, subjects visit the clinic every two

weeks for assessment of skin reactions. The TV domain
schedules these visits, helping maintain a consistent
timeline across all participants.

STUDYID VISITNUM VISIT VISITDY

01-001 1 Screening Visit -14

01-001 2 Week 2 14

01-001 3 Week 4 28
TI (Trial Inclusion/Exclusion Criteria)

The Trial Inclusion/Exclusion (TI) domain records the criteria

used to determine subject eligibility for the trial. It includes
both inclusion criteria (what qualifies a subject) and exclusion
criteria (what disqualifies a subject).

Purpose:

To track the rules that define which subjects can participate in

the study, ensuring the trial's population is aligned with its
objectives. This helps manage study safety and the validity of
results.

Example:

In a dermatology study, subjects must have mild-to-moderate

eczema to qualify. The TI domain documents such inclusion
criteria, as well as exclusion factors like recent use of similar
treatments.

STUDYID CRITTYPE CRITNAME CRITDESC

Subject must be between 18 and 65

01-001 INCLUSION Age Criterion
years old.
No use of other eczema treatments
01-001 EXCLUSION Prior Treatment
in the last 30 days.
TS (Trial Summary)

The Trial Summary (TS) domain contains key summary-level

information about the clinical trial, including the study
design, objectives, and overall structure.

Purpose:

To provide an overview of the clinical trial in a structured

format, offering key details like the study phase, therapeutic
area, and the duration of the study. This serves as a high-
level reference for stakeholders.

Example:

In a dermatology trial, the TS domain summarizes that the

study is a Phase II trial aimed at evaluating the safety and
efficacy of a new skin cream.

STUDYID TSPARMCD TSPARM TSVAL

01-001 PHASE Study Phase Phase II

01-001 TRT Treatment Type Investigational Skin Cream

01-001 DUR Study Duration 6 Months

 Relationship Domains
SUPP (Supplemental Qualifiers)

The Supplemental Qualifiers (SUPP) domain contains

additional data related to other SDTM domains. It is used
when standard domains do not have specific fields for some
collected data, allowing the study team to store
supplementary information.

Purpose:

To add extra information or qualifiers to the core domains.

This is important for capturing non-standard data that
might be crucial to the study but does not fit into predefined
domains.

Example:

In a dermatology trial, if a subject experiences an

unexpected skin reaction not covered in the adverse event
domain (AE), it can be recorded in the SUPP domain for
further detail.

STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QVAL

STUDY-001 AE 01-001 AESEQ 1 SEVDETAILS Severe Rash

STUDY-001 DM 01-001 DMSEQ 1 ETHNIC Asian

 RELREC (Related Records)

The Related Records (RELREC) domain establishes links

between records from different SDTM domains. It allows the
study team to associate data from multiple domains when
they are related, such as linking an adverse event with a
corresponding laboratory test.

Purpose:

To create connections between data points across domains.

This is particularly useful in studies where events or findings
are closely related and need to be interpreted together.

Example:

If a subject experiences an adverse event (AE) during a

dermatology study and a related lab test shows abnormal
liver enzymes, the RELREC domain can link the AE record
with the corresponding laboratory result.

STUDYID RDOMAIN USUBJID IDVAR IDVARVAL RELID

STUDY-001 AE 01-001 AESEQ 1 REL001

STUDY-001 LB 01-001 LBSEQ 3 REL001

Thank you for exploring the classification of
SDTM domains for beginners. If you have
any suggestions or feedback regarding this
guide, please feel free to reach out.
Additionally, if you require any assistance
with Clinical SAS, do not hesitate to contact
me directly. I will be happy to help wherever
possible.

Saurabh Patil
SAS Programmer