Walkthrough SDTM 3.3 Vs 3.4

In November 2021, the SDTMIG v3.4 and SDTM v2.0 were released. Since 2004, CDISC has provided an accepted standard for the submission of tabulation data in the form of the SDTM and SDTMIG. A large amount of information, as well as new tables, including those for domain specific variables, has been updated to the most recent version of SDTM. It includes a summary of the new domains, concepts, and variables.

New SDTM Domains

 SDTM IG v3.4 includes the addition of five new domains. BE stands for biospecimen event domain, and it contains information about actions that affect or may affect a specimen. Three new domains have been added to the finding’s domain class. The biospecimen findings (BS) are data about biospecimen characteristics. CP contains information about cell phenotype, lineage, and function based on the expression of specific markers in single cells or particle suspensions. The Genomic Findings (GF) domain contains information about the structure, function, evolution, mapping, and editing of genomic material of interest from subject and non-host organisms. RELSPEC is a new related specimen domain added to the Relationship class that is used to represent specimen relationships.

The morphology domain (MO) has been removed from the findings class in the SDTM IG v3.4.

Label updates

Table 1. List of label updates to the existing domain

Domain

SDTM IG v3.3

SDTM IG v3.4

DA

Drug Accountability

Product Accountability

TS

Trial Summary Information

Trial Summary 

 

Domain Structure Update

Table 2. List of structure updates

Domain

SDTM IG v3.3

SDTM IG v3.4

DA

One record per drug accountability finding per subject

One record per Product accountability finding per subject

SC

One record per characteristic per subject

One record per characteristic per visit per subject

SS

One record per finding per visit per subject

One record per status per visit per subject

SV

One record per subject per actual visit

One record per actual or planned visit per subject

TI

One record per I/E crierion

One record per I/E criterion

 

Variables removed

Table 3:  List of variables removed from SDTM

Domain

Variable Name

Variable Label

FT

FTEVAL

Evaluator

LB

LBSTREFC

Reference Result in Standard format

MS

MSENDTC

End Date/Time of observation

MS

MSENDY

Study Day of End of Observation

MS

MSENRF

End Relative to Reference Period

MS

MSENRTPT

End Relative to Reference Time Point

MS

MSENTPT

End Reference Time Point

MS

MSMODIFY

Modified Reported Name

MS

MSSPCUFL

Specimen Usability for the Test

MS

MSSTRF

Start Relative to Reference Time Period

MS

MSSTRTPT

Start Relative to Reference Time Point

MS

MSSTTPT

Start reference Time Point

QS

QSEVAL

Evaluator

UR

URSPCUFL

Specimen Usability for the Test

UR

URSPEC

Specimen Material Type


Changes in Variable Labels

Table 4: List of variables with changes in label

Domain

Variable Name

SDTM IG v3.4

SDTM IG v3.3

DV

DVENDY

Study Day of End of Deviation Event

Study Day of End of Observation

FT

FTMETHOD

Method of Test Examination

Method of Test

LB

LBTESTCD

Lab Test or Examination Short Name.

Lab Test or Examination Short Name

SM

DOMAIN

Domain Abbreviation

Domain

SV

SVENDTC

End Date/Time of Observation

End Date/Time of visit

SV

SVENDY

Study Day of End of Observation

Study Day of End of Visit

SV

SVSTDTC

Start Date/Time of Observation

Start Date/Time of visit

SV

SVSTDY

Study Day of Start of Observation

Study Day of Start of Visit

TM

DOMAIN

Domain Abbreviation

Domain

TS

TSVALNF

Parameter value Null Flavor

Parameter Null Flavor

 

Demographics (DM):  Demographics is a special purpose domain that includes a number of essential standard variables and two new variables have been added to the DM domain in the latest version of SDTM. The Date/Time of the First Challenge Agent Administration is RFCSTDTC, and the Date/Time of the Last Challenge Agent Administration is RFCENDTC. These variables will be used if a study uses a protocol-specified challenge agent to induce a condition that the investigational treatment is intended to cure, mitigate, treat, or prevent. In addition, for subjects who do not know their race, the value corresponding to RACE will be “UNKNOWN”, if a subject has race values such as refugee, was adopted, or cases where this information was not available, it could be populated as “UNKNOWN”. Furthermore, the ISO 3166-1 Alpha-3 codelist corresponding to the Country variable has been removed from the IG.

Subject Visits (SV):  Subject Visits is a special purpose domain that contains information about a subject’s actual and planned visits. The major approach change in SV domain is that it is now updated to include a subject’s actual and planned visits. Certain new variables have been added to SV, making the information about the visits easier to understand.

The additional new variables are:

  • SVPRESP: The pre-specified variable must have Y values for the planned visit.
  • SVOCCUR: Based on the occurrence of visits the variable may have values Y/N.
  • SVREASOC: The usage of reason for occur variable is to find the reason for the non-occurrences. 
  • SVCNTMOD: The contact mode variable is used to identify the mode of communication such as In-person, Telephone call, IVRS.
  • SVEPCHGI: The pandemic or EPI related change indicator visit used to indicates whether the visit was changed due to an epidemic or pandemic. 

Adverse Events (AE): AE is an events domain that contains information regarding untoward occurrences in a patient or subject due to the administration of a pharmaceutical product and which may not have any causal relationship with the treatment. There is addition of certain new variables to the domain for the medical devices. SPDEVID be the sponsor device identifier which is a sequence of characters used by the sponsor to uniquely identify a specific device. AEACNDEV be the other variable, it is an action taken with a device as the result of the event. Relationship of event to device (AERLDEV) is the relationship to a device identified in the data. AEUNANT (Unanticipated Adverse Device effect) denotes any serious adverse effect on health or safety or any life-threatening problem or death caused by or associated with a device. Rel or AE to Non-Dev-Rel study activity (AERLPRT) is the   investigator’s assessment of the event’s causality in relation to other protocol required activities, actions or assessments such as implant/insertion, revision/adjustment, explant/removal etc. Another additional variable is AESINTV which are the records whether medical or surgical interventions was necessary to preclude permanent impairment of a body function, or to prevent permanent damage to a body structure, with either situation suspected to be due to the use of a medical product.

Product Accountability (DA): Product accountability is a findings domain which includes information on the receipt, dispensing, return and packaging. In SDTM v3.4, the label corresponding to DA has been changed to product accountability. DA is updated to record the study products such as study drug, nutrition transferred to or from the study subject.  Device transfers are not captured in this domain, but are included in Device tracking and Disposition (DT).

Findings About (FA):  – The major update to the findings about domain FA is that records in FA may or may not have a parent record in an events or interventions domain. If an FA record has a parent record, the value in FAOBJ should correspond to the value in —TERM or —TRT, unless the parent domain is dictionary coded or subject to controlled terminology, in which case FAOBJ should correspond to the value in —DECOD.

Immunogenicity Specimen assessments (IS):  One of the most significant changes in the IS domain is the definition, which has been changed from ‘A findings domain for assessments that determine whether a therapy induced an immune response’ to ‘A findings domain for assessments of antigen-induced humoral or cell-mediated immune response in the subject.’ The IS domain captures assessments that clearly describe whether an allergen, microorganism, or endogenous molecule provoked/caused/induced an immune response in a subject, such as a subject’s antibody reaction (autoantibodies) against auto/self-antigens for auto-immune studies or antibody production in response to allergens. The IS domain will also include evaluations of antibodies produced in response to microbial infection.

Laboratory Test Results (LB): 

Table 5: List of variables newly added to LB.

Variable Name

Variable Label

Usage

LBTSTCND

Test Condition

Identifies any planned condition imposed by the assay system on the specimen at the time the test is performed.

LBBDAGNT

Binding Agent

The LBBDAGNT variable is used to indicate that there is a binding relationship between the entities in the LBTEST and LBBDAGNT variables.

LBTSTOPO

Test operational Objective

Text description of the high-level purpose of the test at the operational level. (Confirmatory, Quantification or Screening test)

LBRESSCL

Result Scale

Classifies the scale of the original result value; for example, in ordinal, nominal, Quantitative or narrative.

LBRESTYP

Result Type

Classifies the kind of result (ie. Property type) originally reported for the test. Example include substances concentration, proportion, mass rate and arbitrary concentration.

LBCOLSRT

Collected Summary Result Type

Used to indicate the type of collected summary result. This includes source summary results collected on a CRF or provided by an external vendor. 

LBLOD

Lower Limit of Detection

The lowest threshold (as originally resolved or collected) for reliably detecting presence or absence of substance measured by a specific test.

LBSPCUFL

Specimen Usability for the Test

Describes the usability of the specimen for the Test (Y/N).

LBANMETH

Analysis Method

Analysis method applied to obtain a summarized result. Analysis method describes the method of secondary processing applied to a complex observation result.

LBTMTHSN

Test method sensitivity

The sensitivity of the test methodology with respect to observation, detection, or Quantification.

LBCLSIG

Clinically Significant, Collected

Used to indicate whether a collected observation is clinically significant based on judgement.

LBPTFL

Point in Time Flag

An indication that the specimen was collected at a single point in Time. The value is Y or ‘Null’.

LBPDUR

Planned Duration

Planned duration of specimen collection. If LBPTFL is “Y” then LBPDUR is null.

 

Other Major Updates

  • For all datasets containing subject-level data must have the unique subject identifiers. USUBJID values must be unique for each trial subjects in all the study. This means there may not be two or more USUBJID for the same subjects. Specific format is not needed for the USUBJID. 
  • In SDTM IG V3.4, values for “ISO8601” have been updated to be more specific.
  • ISO 8601 datetime or interval:  For 25 variables ​
  • ISO 8601 duration                    :  For 11 Variables ​
  • ISO 8601 duration or interval: For 1 Variable – –EVLINT Variable
  • The reason for occur value (–REASOC) is added to the EC domain. 
  • For the PRDECODE variable, added CT reference to the procedure codelist (PROCEDUR).  
  • The new variable –CLSIG is added to the LB, VS and EG domains. 
  • The core value corresponding to DSDY updated to permissible from expected. Also, the DSSTDY core value has been updated to expect from permissible. 

 

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