Page History
The following new section was added:
- Section 6.8, Related References Dataset
New variables have been added to the following sections:
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.
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- Section 3.1.3 The Findings Observation Class
- --CELLEV, Number of Cells Evaluated
- --CELLEV, Number of Cells Evaluated
- Section 3.1.4, Identifiers for All Classes
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- SPTOBID, Applicant-defined Tobacco Product Identifier
- IGDCMPID, Ingredient or Component Identifier
- STOCONID, Applicant-defined Storage Conditions ID
- SPTOBID, Applicant-defined Tobacco Product Identifier
Many variable labels, notes, definitions, or examples were modified. In most cases, these modifications were to use the phrase "treatment or product" for the case when product use is not considered a treatment. In some cases a definition was added where there was none before. The type and location of revisions made are described in the following tables.
VARIABLES | |||||
|---|---|---|---|---|---|
Modifications made to existing Variable | |||||
Variable | Section | Label | Notes | Definition | Examples |
--TRT | Section 3.1.1, The Interventions Observation Class | X | X | X | |
--RSDISC | Section 3.1.1, The Interventions Observation Class | X | X | ||
--DOSFRM | Section 3.1.1, The Interventions Observation Class | X | |||
--DOSFRQ | Section 3.1.1, The Interventions Observation Class | X | |||
--DOSTOT | Section 3.1.1, The Interventions Observation Class | X | |||
--DOSRGM | |||||
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.
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Section 3.1.1, The Interventions Observation Class | X | ||||
-- |
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ACN | Section 3.1.2, The Events Observation Class | X | X | ||
--ACNOTH |
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Section 3.1.2, The Events Observation Class |
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X | |||
-- |
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REL | Section 3.1.2, The Events Observation Class | X | |||
--RLDEV | Section 3.1.2, The Events Observation Class | X | |||
--SPEC |
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Section 3.1.3, The Findings Observation Class |
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X | X | ||||
ACTARMUD | Section 3.2.1, Demographics | X | |||
RFENDTC | Section 3.2.1, Demographics | X | |||
RFSTDTC | Section 3.2.1, Demographics | X | |||
RFXENDTC | Section 3.2.1, Demographics | X | X | ||
RFXSTDTC | Section 3.2.1, Demographics | X | X | ||
SETCD | Section 5.1.2, Trial Sets | X |
The following textual changes have been made:
| Section # | Section Name | Prior Text (SDTM v2.0) | New Text (SDTM v2.1) |
|---|---|---|---|
| 1.2 | Implementation Advice for this Model | The SDTM has been designed to accommodate the broadest range of human and animal study data... | The SDTM has been designed to accommodate the broadest range of human and nonclinical study data... |
| 1.2 | Implementation Advice for this Model | Individual IGs have been created to provide specific recommendations for numerous domains of data commonly collected in human, animal, and medical device studies.... | Individual IGs have been created to provide specific recommendations for numerous domains of data commonly collected in human, nonclinical, and medical device studies.... |
| 1.2 | Implementation Advice for this Model | The following implementation guides have been published by CDISC: |
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| 2 | Model Concepts and Terms – Organization of the SDTM | The SDTM provides a general framework for describing the organization of information collected during human and animal studies. | The SDTM provides a general framework for describing the organization of information collected during human and nonclinical studies. |
| 2 | Model Concepts and Terms – Organization of the SDTM | The primary purpose of the SDTM is to represent data about study subjects—which may be humans or animals—or medical devices. | The primary purpose of the SDTM is to represent data about study subjects (e.g., humans, animals, medical devices). |
| 3.1 | The General Observations Classes | The Interventions Observation Class represents investigational, therapeutic, and other treatments that are administered to or used by a subject (with some actual or expected physiological effect). This includes treatments specified by the study protocol (i.e., "exposure"). | The Interventions Observation Class represents, investigational, therapeutic, and other treatments and products that are administered to or used by a subject (with some actual or expected physiological effect). This includes treatments and products specified by the study protocol (i.e., "exposure"). |
| 5.1 | The Trial Design Model | The Trial Design Model defines a standard structure for representing the planned sequence of activities and the treatment plan for the trial. | The Trial Design Model defines a standard structure for representing the planned sequence of activities and plan for the trial. |
| 5.1 | The Trial Design Model |
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- --PTFL, Point in Time Flag
- --PDUR, Planned Duration
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- SESTDY, Study Day of Start of Element
- SEENDY, Study Day of End of Element
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- 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:
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| Pagenav |
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