Page History

Minor updates to the introduction were made to broaden the use cases and describe the relationship to older versions of the SDTM. A concept map showing the organization of the model was also added.

In examples of qualifier types, specific variable names have been replaced with descriptions because the variables are introduced later in the document. The description of Synonym Qualifiers was updated to reflect that some variables are synonym qualifiers of multiple variables.

The relationships domain Related Specimens (RELSPEC) was added.

Sections were reordered and regrouped, which resulted in the renumbering of sections and the elimination of some unnecessary section layers. The metadata tables now have Variable(s) Qualified, Usage Restrictions, Variable C-code, Definition, and Examples columns. The Notes column replaces the former Description column. A section called Table Structure has been added to show the variable metadata included in the tables. 

The section header Version History was removed. It was an unnecessary extra layer, because this section deals only with the changes from one version to the next. The Variable, Dataset, and Section Changes and Additions subsection was removed, as this was also an unnecessary extra layer.

Table numbers were removed, as they are redundant with section numbers.

Usage restrictions of "Not in nonclinical trials" were added.

A new section, Study Subject Data, was created which groups the general observation classes and special-purpose domains.

The variable APID was removed from Section 3.1.4, Identifiers for All Classes, because APID is only allowed in AP domains. It is still listed in new Section 4, Associated Persons Data.

The variables qualified for --DOSFRM, --DOSFRQ, and --DOSRGM were changed from --DOSE, --DOSTXT, and --DOSTOT to --TRT.

Because the role of the domain-specific variable --BEATNO was changed to Identifier, it was moved from Section 3.1.3, The Findings Observation Class, to Section 3.1.4, Identifiers for All Classes. --LNKID and --LNKGRP have been revised to clarify that the relationships are within a subject.

The special-purpose Subject Visits (SV) domain remains a special-purpose domain, but additional variables have been added to address the effect of an epidemic or pandemic on visits.

The role of the --LOINC variable was changed from Synonym Qualifier of --TESTCD to Record Qualifier. A single variable of --TESTCD may be associated with multiple values of --LOINC, depending on the values of other variables, such as --SPEC and --METHOD. The order of --METHOD was changed so that the variable appears after --PORTOT, rather than after --LOC.

The Trial Design Model has been reorganized and revised. Text in the top-level section was revised to replace a specific list of trial design concepts with a more general statement about the use of variables from trial design domains being used in subject-level domains. 

The role of the Trial Disease Milestones variable TMDEF was changed to Variable Qualifier with MIDSTYPE as the variable qualified.

New variables have been added to the following sections. Many of these are restricted to use in particular domains, as noted in the Usage Restrictions column.

• Section 3.1.1, The Interventions Observation Class
  • --REASOC, Reason for Occur Value
  • --CNTMOD, Contact Mode
  • --EPCHGI, Epi/Pandemic Change Indicator
• Section 3.1.2, The Events Observation Class
  • --REASOC, Reason for Occur Value--CNTMOD, Contact Mode
  • --EPCHGI, Epi/Pandemic Change Indicator
  • --RELDEV, Relationship of Event to Device
  • --SINTV, Needs Intervention to Prevent Impairment
  • --UNANT, Unanticipated Adverse Effect/Event
  • --RLPRT, Rel of AE to Device-Related Procedure
  • --RLPRC, Rel of AE to Non-Dev-Rel Study Activity
• Section 3.1.3, The Findings Observation Class
  • --SBMRKS, Sublineage Marker String
  • --CELSTA, Cell State
  • --CSMRKS, Cell State Marker String
  • --CNTMOD, Contact Mode
  • --EPCHGI, Epi/Pandemic Related Change Indicator
  • --TSTCND, Test Condition
  • --CNDAGT, Test Condition Agent
  • --BDAGNT, Binding Agent
  • --ABCLID, Antibody Clone Identifier
    
  • --MRKSTR, Marker String
    
  • --GATE, Gate
  • --GATEDEF, Gate Definition
  --TSTOPO, Test Operational Objective
  • --MSCBCE, Molecule Secreted by Cells
  • --SPTSTD, Sponsor Test Description
    
  • --TSTPNL, Test Panel
  • --RESSCL, Result Scale
  • --RESTYP, Result Type
  • --COLSRT, Collected Summary Result Type
  • --LLOD, Lower Limit of Detection
  • --INHERT, Inheritability
  • --GENREF, Genome Reference
  • --CHROM, Chromosome Identifier
  • --SYM, Genomic Symbol
  • --SYMTYP, Genomic Symbol Type
  • --GENLOC, Genetic Location
  • --GENSR, Genetic Sub-Region
  • --SEQID, Sequence Identifier
  • --PRVID, Published Variant Identifier
  • --COPYID, Copy Identifier
  • --TMTHSN, Test Method Sensitivity
  • --CLSIG, Clinically Significant, Collected
  • --REASPF, Reason Test Performed
• Section 3.1.5, Timing Variables for All Classes.
  • --PTFL, Point in Time Flag
  • --PDUR, Planned Duration
• Section 3.2.3.2, Subject Elements
  • SESTDY, Study Day of Start of Element
    
  • SEENDY, Study Day of End of Element
    
• Section 3.2.3.3, Subject Visits
  • SVPRESP, Pre-Specified
  • SVOCCUR, Occurrence
  • SVREASOC, Reason for Occur Value
  • SVCNTMOD, Contact Mode
  • SVEPCHGI, Epi/Pandemic Related Change Indicator

The following new section was added:

Section 6.7x,   Related Specimens Refrerences Dataset