Page History
The following new section was added:
- Section 6.8, Related References Dataset
Some new variables
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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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VARIABLES | ||||||||||||||||||
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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 1, Demographics | X | X | |||||||||||||||
RFENDTC | Section 3.2.1 1, Demographics | X | ||||||||||||||||
RFSTDTC | Section 3.2.1 1, Demographics | X | ||||||||||||||||
RFXENDTC | Section 3.2.1 1, Demographics | X | X | |||||||||||||||
RFXSTDTC | Section 3.2.1 1, Demographics | X | X |
The following textual changes have been made:
Section # | Section Name | Prior Text (SDTM v2.0) | New Text (SDTM v2.1) |
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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., 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 |
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