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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.
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Modifications made to existing Variable | ||||||||||||||||||
Variable | Section | New Variable | Label | Notes | Definition | Usage Restrictions? | Examples | Removed Variable
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--TRT | Section 3.1.1 The Interventions Observation Class | X | X | X | ||||||||||||||
--RSDISC
| Section 3.1.1 The Interventions Observation Class | X | 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 | |||||||||||||||
--CELLEV | Section 3.1.3 The Findings Observation Class | X | ||||||||||||||||
GNTXAID | Section 3.1.4 Identifiers for All Classes | X | ||||||||||||||||
SPTOBID | Section 3.1.4 Identifiers for All Classes | X | ||||||||||||||||
STOCONID | Section 3.1.4 Identifiers for All Classes | 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 | 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 | ...(IGs) have been created to provide specific recommendations for numerous domains of data commonly collected in human, animal, and medical device studies,,,, | ...(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, such as humans, animals, or 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 | Planned treatment arms (Section 5.1.1... | Planned arms (Section 5.1.1... |
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