Data Collection
Data Tabulation
From SDTMIG
Conformance with the SDTMIG domain models is minimally indicated by:
- Following the complete metadata structure for data domains
- Following SDTMIG domain models wherever applicable
- Using SDTM-specified standard domain names and prefixes where applicable
- Using SDTM-specified standard variable names
- Using SDTM-specified data types for all variables
- Following SDTM-specified controlled terminology and format guidelines for variables, when provided
- Including all collected and relevant derived data in one of the standard domains, special-purpose datasets, or general observation class structures
- Including all Required and Expected variables as columns in standard domains, and ensuring that all Required variables are populated
- Ensuring that each record in a dataset includes the appropriate Identifier and Timing variables, as well as a Topic variable
- Conforming to all business rules described in the CDISC Notes column and general and domain-specific assumptions
Data Analysis
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