The Structured Data Transformation Model (SDTM) is a standard for the structure and content of clinical trial tabulation datasets that are submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
This tool is a browser for the SDTM data model that displays the polyhierarchy of SDTM classes and domains as a tree. You can browse the attributes of each class and view their descriptions by clicking on the purple links. The structure of classes is rendered as a TypeScript-like type definition.
Class hierarchy
Associated persons are individuals other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. The structures of SDTM datasets that represent data about associated persons are based on the structures for data about study subjects, either general observation class structures or special-purpose domain structures. AP domains are created using SDTM variables, with the application of specific AP rules. (Source: SDTM v2.0, Section 4)
This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. (Source: CDISC Controlled Terminology, GNRLOBSC, RELATIONSHIP, 2021-09-24)
Class attributes
Study subject data
General observation classes
The majority of observations collected during a study can be divided among three general classes: Interventions, Events, or Findings. Datasets based on any of the general observation classes share a set of common Identifier and Timing variables. As a general rule, any valid Identifier or Timing variable is permissible for use in any submission dataset based on a general observation class. (Source: SDTM v2.0, Section 3.1)
type = ( | ) & {
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}
Interventions
This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). (Source: CDISC Controlled Terminology, GNRLOBSC, INTERVENTIONS, 2021-09-24)
type = & {
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: number,
: string,
: string,
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}
Events
This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). (Source: CDISC Controlled Terminology, GNRLOBSC, EVENTS, 2021-09-24)
type = & {
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}
Findings
This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. (Source: CDISC Controlled Terminology, GNRLOBSC, FINDINGS, 2021-09-24)
type = & {
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}
Findings about
This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. (Source: CDISC Controlled Terminology, GNRLOBSC, FINDINGS ABOUT, 2021-09-24)
type = & {
: string
}
Special-purpose domains
This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. (Source: CDISC Controlled Terminology, GNRLOBSC, C103377, 2021-06-25)
DM (Demographics)
A special-purpose domain that 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.
type = {
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}
CO (Comments)
A special-purpose domain that contains comments that may be collected alongside other data.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: number
}
SE (Subject Elements)
A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: number,
: string,
: string,
: string,
: number,
: number,
: string
}
SJ (Subject Repro Stages)
Describes the actual order of reproductive stages that were experienced by the subject, together with the start date/time and end date/time for each reproductive stage.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string
}
SV (Subject Visits)
A special purpose domain that contains information for each subject's actual and planned visits.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: number,
: number,
: string
}
SM (Subject Disease Milestones)
A special-purpose domain that is designed to record the timing, for each subject, of disease milestones that have been defined in the Trial Disease Milestones (TM) domain.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: number,
: number
}
Associated persons data
Associated persons are individuals other than study subjects who can be associated with a study, a particular study subject, or a device used in the study. The structures of SDTM datasets that represent data about associated persons are based on the structures for data about study subjects, either general observation class structures or special-purpose domain structures. AP domains are created using SDTM variables, with the application of specific AP rules. (Source: SDTM v2.0, Section 4)
type = {
: string,
: string,
: string,
: string
}
General observation classes
The majority of observations collected during a study can be divided among three general classes: Interventions, Events, or Findings. Datasets based on any of the general observation classes share a set of common Identifier and Timing variables. As a general rule, any valid Identifier or Timing variable is permissible for use in any submission dataset based on a general observation class. (Source: SDTM v2.0, Section 3.1)
type = ( | ) & {
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: number,
: string,
: string,
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: string,
: string,
: number,
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}
Interventions
This SDTM class captures investigational, therapeutic and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study drug), coincident with the study assessment period (e.g., concomitant medications), or self-administered by the subject (such as use of alcohol, tobacco, or caffeine). (Source: CDISC Controlled Terminology, GNRLOBSC, INTERVENTIONS, 2021-09-24)
type = & {
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: string,
: number,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string
}
Events
This SDTM class captures planned protocol milestones such as randomization and study completion, and occurrences, conditions, or incidents independent of planned study evaluations occurring during the trial (e.g., adverse events) or prior to the trial (e.g., medical history). (Source: CDISC Controlled Terminology, GNRLOBSC, EVENTS, 2021-09-24)
type = & {
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}
Findings
This SDTM class captures the observations resulting from planned evaluations to address specific tests or questions such as laboratory tests, ECG testing, and questions listed on questionnaires. (Source: CDISC Controlled Terminology, GNRLOBSC, FINDINGS, 2021-09-24)
type = & {
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}
Findings about
This SDTM class is a specialization of the findings general observation class. It is intended, as its name implies, to be used when collected data represent findings about an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. (Source: CDISC Controlled Terminology, GNRLOBSC, FINDINGS ABOUT, 2021-09-24)
type = & {
: string
}
Special-purpose domains
This SDTM class contains a set of domains which do not conform to the Findings, Events or Interventions observation classes. The domains included are DM, CO, SE and SV. (Source: CDISC Controlled Terminology, GNRLOBSC, C103377, 2021-06-25)
DM (Demographics)
A special-purpose domain that 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.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
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: string,
: string,
: string,
: string,
: number,
: string,
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: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: number
}
CO (Comments)
A special-purpose domain that contains comments that may be collected alongside other data.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: number
}
SE (Subject Elements)
A special-purpose domain that contains the actual order of elements followed by the subject, together with the start date/time and end date/time for each element.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: number,
: string,
: string,
: string,
: number,
: number,
: string
}
SJ (Subject Repro Stages)
Describes the actual order of reproductive stages that were experienced by the subject, together with the start date/time and end date/time for each reproductive stage.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string
}
SV (Subject Visits)
A special purpose domain that contains information for each subject's actual and planned visits.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: number,
: number,
: string
}
SM (Subject Disease Milestones)
A special-purpose domain that is designed to record the timing, for each subject, of disease milestones that have been defined in the Trial Disease Milestones (TM) domain.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: number,
: number
}
Study-level data
Trial design
This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control group, method of allocating treatments, blinding methods, assignment of epochs that subjects pass through in the course of a trial. (Source: CDISC Controlled Terminology, GNRLOBSC, TRIAL DESIGN, 2021-09-24)
TE (Trial Elements)
A trial design domain that contains the element code that is unique for each element, the element description, and the rules for starting and ending an element.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
TA (Trial Arms)
A trial design domain that contains each planned arm in the trial.
type = {
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string
}
TX (Trial Sets)
A trial design domain that contains one record for each trial set characteristic including experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations. This domain is not subject oriented.
type = {
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: string
}
TT (Trial Repro Stages)
Describes the planned unique reproductive stages in a non-clinical developmental and reproductive toxicology study, with reproductive stage code, description, and rules for start and end.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
TP (Trial Repro Paths)
Describes each planned reproductive path in a non-clinical developmental and reproductive toxicology study, with the ordered sequence of reproductive stages that comprise each reproductive path.
type = {
: string,
: string,
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: number
}
TV (Trial Visits)
A trial design domain that contains the planned order and number of visits in the study within each arm.
type = {
: string,
: string,
: number,
: string,
: number,
: string,
: string,
: string,
: string
}
TD (Trial Disease Assessments)
A trial design domain that provides information on the protocol-specified disease assessment schedule, to be used for comparison with the actual occurrence of the efficacy assessments in order to determine whether there was good compliance with the schedule.
type = {
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: number
}
TM (Trial Disease Milestones)
A trial design domain that is used to describe disease milestones, which are observations or activities anticipated to occur in the course of the disease under study, and which trigger the collection of data.
type = {
: string,
: string,
: string,
: string,
: string
}
TI (Trial Inclusion/Exclusion)
A trial design domain that contains one record for each of the inclusion and exclusion criteria for the trial. This domain is not subject oriented.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
TS (Trial Summary)
A trial design domain that contains one record for each trial summary characteristic. This domain is not subject oriented.
type = {
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
AC (Challenge Agent Characterization)
A special purpose domain for the characterization of challenge agents (i.e., the substances administered to cause the diseases or conditions of interest) for those study designs that involve the use of a challenge agent.
type = {
: string,
: string,
: number,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
Study reference datasets
This special purpose SDTM class contains further descriptions of study-specific identifiers that will be used in subject based domains. (Source: CDISC Controlled Terminology, GNRLOBSC, STUDY REFERENCE, 2021-09-24)
DI (Device Identifiers)
A special-purpose domain containing information that identifies a specific device unit.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string
}
OI (Non-host Organism Identifiers)
A special-purpose domain containing information that identifies levels of taxonomic nomenclature of microbes or parasites that have been either experimentally determined in the course of a study or are previously known, as in the case of lab strains used as reference in the study.
type = {
: string,
: string,
: string,
: number,
: string,
: string,
: string
}
Relationship datasets
This SDTM class provides a means to link related records between datasets. It includes the RELREC and SUPPQUAL datasets. (Source: CDISC Controlled Terminology, GNRLOBSC, RELATIONSHIP, 2021-09-24)
RELREC (Related Records)
A dataset used to describe relationships between records for a subject within or across domains, and relationships of records across datasets.
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
SUPPQUAL (Supplemental Qualifiers)
type = {
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string,
: string
}
POOLDEF (Pool Definition)
A dataset that identifies individual subjects included in a pool of subjects for which a single observation record (pool level) is captured.
type = {
: string,
: string,
: string,
: string
}
RELSUB (Related Subjects)
A dataset used to represent relationships between study subjects.
type = {
: string,
: string,
: string,
: string,
: string
}
DR (Device-Subject Relationships)
A special-purpose domain that contains the linkage of each subject to the device(s) to which they may have been exposed during the study.
type = {
: string,
: string,
: string,
: string
}
APRELSUB (Associated Persons Related to Subjects)
type = {
: string,
: string,
: string,
: string,
: string
}
RELSPEC (Related Specimens)
A dataset used to represent relationships between specimens.
type = {
: string,
: string,
: string,
: string,
: string,
: number
}
See also
FHIR type tree - Visualizing the hierarchy of FHIR data types and resources.