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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 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 treatments specified by the study protocol (i.e., "exposure"). | 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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