The following new section was added:
- Section 6.8, Related References Dataset
New variables have been added to the following sections:
- 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
- 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 SDTM-820 - Getting issue details... STATUS 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 | Section 3.1.1, The Interventions Observation Class | X | |||
--ACN | Section 3.1.2, The Events Observation Class | X | X | ||
--ACNOTH | Section 3.1.2, The Events Observation Class | X | |||
--REL | Section 3.1.2, The Events Observation Class | X | |||
--SPEC | Section 3.1.3, The Findings Observation Class | X | X | ||
--XDY | Section 3.1.5, Timing Variables for All Classes | X | |||
--XENDY | Section 3.1.5, Timing Variables for All Classes | X | |||
--XSTDY | Section 3.1.5, Timing Variables for All Classes | 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 |
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 |
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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 | 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 | 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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