The variable label, definition, and/or notes associated with the following variables have been changed in the following sections:
- Section 3.1.1 The Interventions Observation Class
- --TRT
- --RSDISC
- --DOSFRM
- --DOSFRQ
- --DOSTOT
- --DOSRGM
- Section 3.1.2 The Events Observation Class
- --ACN
- --ACNOTH
- --REL
- Section 3.1.3 The Findings Observation Class
- --SPEC
- Section 3.1.5 Timing Variables for All Classes
- --XDY
- --XENDY
- --XSTDY
- Section 3.2.1 Demographics
- ACTARMUD
- RFENDTC
- RFSTDTC
- RFXENDTC
- RFXSTDTC
Two variables have been added to the following section. Both of these are restricted in use, as noted in the Usage Restrictions column.
- Section 3.1.4 Identifiers for All Classes
- GNTXAID
- SPTOBID
The following new section was added:
- Section 6.8 Related References Dataset
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 |
|
| 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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