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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