Page History
The following new section was added:
- Section 6.8, Related References Dataset
Some new variables
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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
- 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 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 | DefinitionUsage Restrictions? | Examples | Removed Variable||||||||
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 | key | SDTM-772|||||||||||
--TRT | Section 3.1.1, The Interventions Observation Class | X | X | X | |||||||||
--RSDISC | |||||||||||||
| showSummary | false | ||||||||||||
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 | key | SDTM-773Section 3.1.1, The Interventions Observation ClassX | 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 | |||||||||||
--SPECRLDEV | Section 3.1.3 2, The Findings Events Observation ClassX | X | |||||||||||
--CELLEVSPEC | Section 3.1.3, The Findings Observation Class | X | GNTXAID | Section 3.1.4 Identifiers for All Classes | X | ||||||||
SPTOBIDACTARMUD | Section 3.1.4 Identifiers for All Classes | X | STOCONID | Section 3.1.4 Identifiers for All Classes2.1, Demographics | X | ||||||||
--XDYRFENDTC | 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 | 2.1, Demographics | X | |||
RFSTDTCACTARMUD | |||||||||||||
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 | key | SDTM-774Section 3.2.1 1, Demographics | X | X | ||||||||
RFENDTCRFXENDTC | Section 3.2.1 1, Demographics | X | RFSTDTC | Section 3.2.1 Demographics | X | ||||||||
RFXENDTCRFXSTDTC | Section 3.2.1 1, Demographics | X | X | ||||||||||
RFXSTDTCSETCD | Section 35.1.2.1 Demographics X | X | |||||||||||
The following textual changes have been made:
| Section # | Section Name | Prior Text (SDTM v2.0) | New Text (SDTM v2.1) |
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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 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 and nonclinical studies. |
| 2 | Model Concepts and Terms – Organization of 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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| Pagenav |
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Overview
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