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| Metadataspec |
|---|
| Category | Standards for Collection | Standards for Tabulation | Standards for Analysis |
|---|
| Product Description |
| Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) | | Nonclinical |
| Study Data Tabulation Model (SDTM) |
| | Product Impact on Individual Health | Clinical Data Acquisition Standards Harmonization (CDASH) Model | Study Data Tabulation Model (SDTM) | Analysis Data Model (ADaM) | | Product Impact on Population Health |
|
| Analysis Data Model (ADaM) |
|
Subjects are... Note that generally the term "trial" is equivalent to "study" in the nonclinical context. In addition, "subjects" are equivalent to "animals."
Values in this column should be used with values in TIG Core to determine when a field should be present on a CRF.
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